All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.
Diabetes Reversal Roadmap is backed with a 60 Day No Questions Asked Money Back Guarantee. If within the first 60 days of receipt you are not satisfied with Wake Up Lean™, you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.
Going slow has always been accompanied by an air of wisdom. “Adopt the pace of nature,” advised Ralph Waldo Emerson. “Her secret is patience.” A couple millennia and change before that, Lao Tzu said something similar: “Nature does not hurry, yet everything is accomplished.”
Yet these days, paeans to slowness have taken on a slightly more urgent tone. “We are on a bus speeding faster and faster toward a cliff, and we celebrate every added mile per hour as progress,” wrote the French economist Timothée Parrique in Slow Down or Die, published last May. “It’s madness. Maximizing growth is like stepping on the accelerator with the absolute certainty of dying in a social and ecological collapse.”
The Japanese philosopher and economist Kohei Saito covered similar territory in Slow Down, his 2024 degrowth manifesto. Our obsession with GDPs is contributing not only to our collective suffering but to our eventual demise. After all, economic growth might be seen as the societal manifestation of individual craving—we want, therefore we buy.
In the age of AI, when the average person consumes more information in a day than someone in the 15th century would have in their entire lifetime, one can see why slowness feels essential. People are caught up in the rat race, leading stressful, overly connected lives. Yet it is one thing to slow down at a systemic level, and quite another to slow down as an individual.
In the age of AI, when the average person consumes more information in a day than someone in the 15th century would have in their entire lifetime, one can see why slowness feels essential.
Can mindfulness help us take our foot off the accelerator? And can a personal practice have a meaningful impact on the speed at which society moves?
Doing Mode to Being Mode
“Mindfulness practice is certainly a tangible way of slowing down,” says mindfulness scholar Andrew Olendzki. “If only for a brief session, one deliberately drops out of ‘doing’ mode to linger in ‘being’ mode.”
Lingering in being mode has a tangible impact on our internal speedometer. “Mindfulness practice is a way of re-training oneself to slow down in every way, and the rate of breathing is the most accessible way of doing this,” says Olendzki.
Indeed, research shows that long-term meditators display slower respiratory rates than non-meditators. Being able to slow down physiologically when one is operating at a higher register might bring a degree of deliberateness to “fast-paced” endeavors. It can help us embody the tortoise despite the prevalence of so many hares.
Being able to slow down physiologically when one is operating at a higher register might bring a degree of deliberateness to “fast-paced” endeavors. It can help us embody the tortoise despite the prevalence of so many hares.
When this deliberateness pervades the body, it can extend to the mind, providing a countercurrent to the speed at which modern life moves. It can teach us not just to slow down during common contemplative practices, like meditation or journaling or yoga, but to access a lower gear in the midst of the everyday, which is when we most feel the pressure to maintain forward momentum.
“For most people today, the speed comes from external engagements: busy schedules, phones set to notify every incoming message, and the basic tendency to ‘do a lot’ in the modern lifestyle,” says Olendzki. “I think the pace at which one lives one’s life is a matter of habit, and like all habits is learned. Much in our society encourages moving fast, and I like to think we still have some choice in how much we participate in this.”
Unlearning Our Addiction to Speed
In some respects, then, slowing down involves a type of unlearning. We are so used to moving at the speed of information that we don’t realize that we don’t have to respond to every notification that vibrates in our pockets. The anthropologist Thomas Hylland Eriksen distinguished between “fast time”—writing an email or completing a report, and “slow time”—leisure activities like creating art or sitting still. He noted that when fast time and slow time meet—deadline pressure versus writing poetry—fast time always wins. But when we notice this imbalance we can choose to prioritize slow time.
Mindfulness might support our efforts to slow down insofar as it reorients us toward the rhythm of the breath, the pace of nature, and the workability of the mind.
We may need support in making this choice. Perhaps this is why the past couple of years have seen books about Slow Birding, Slow Productivity, Slow Pleasure, and Slow Seasons—a guide to reconnecting with nature. In an age of abundance those of us in privileged positions are not thirsty for more but for less.
In this sense, Lao Tzu, Emerson, and Weller may be on to something when they advise us to take a cue from natural rhythms. In his book Weller recalled his mentor, Clarke Berry, placing his hand on a rock and indicating that he operates at geologic speed:
Geologic speed—the rhythm of eons, of millennia—is etched deep in our bones. When we grant ourselves the time and pace of stone, we come into a deep memory of who we are, where we belong and what is sacred. We remember the values associated with this ancient cadence, among them patience, restraint, and reciprocity.
Mindfulness might support our efforts to slow down insofar as it reorients us toward the rhythm of the breath, the pace of nature, and the workability of the mind. Whether or not that can address the political and economic issues that plague society is questionable, but individuals that can achieve respite may help shape systems that prioritize it. After all, mindfulness isn’t about getting anywhere, or getting ahead, or even getting it.
“Be as mindful as you can of the pace you inhabit in any given day,” wrote Weller. “Try to notice what happens when you slow down and enter the stream of connection with the daylight, the wind, the sounds of the city, birdsong, cricket, or silence.”
Life may be terminal, but our velocity doesn’t have to be.
“Intervention studies to enhance healthy ageing need appropriate outcome measures, such as blood-borne biomarkers, which are easily obtainable, cost-effective, and widely accepted.” We need blood-borne biomarkers of mortality risk. For example, having higher levels of C-reactive protein in your blood may increase your risk of dying prematurely by 42%. C-reactive protein is one of the most widely used inflammatory biomarkers for predicting mortality, but those with the highest levels of interleukin-6 (IL-6), another marker of inflammation, may increase premature death risk by 49%. What can we do to bring it down?
I’ve previously talked about foods that can contribute to inflammation, like meat and sugar, versus foods like nuts that don’t. But what about anti-inflammatory foods that actually attenuate that inflammation?
What happens when blueberries are added to a high-fat, high-glycemic-load meal consisting of white potatoes, white bread, ham, cheese, and butter? Adding a single cup of blueberries caused a significant drop in IL-6 from that meal, as you can see below and at 1:15 in my video Which Foods Are Anti-Inflammatory?.
What about raspberries? People were fed eggs, butter, white potatoes, white flour biscuits, and sausage with or without two cups of frozen raspberries blended with water into a smoothie, compared to giving others the same amount of calories and carbs in banana form. Bananas were no match for meat, eggs, dairy, and crappy carbohydrates; that meal resulted in a tripling of IL-6 levels within four hours. But by drinking those two cups of raspberries instead, their bodies were able to hold the line, as you can see below and at 1:45 in my video.
Why did raspberries work but bananas didn’t? Maybe it’s the antioxidants.
Well, antioxidant supplementsfailed miserably. There was no benefit from antioxidant vitamins and minerals like vitamins C or E, beta-carotene, or selenium. Maybe it’s those special antioxidant pigments, the anthocyanins, that give berries those bright red, blue, and purple colors? Indeed, that’s what dozens of randomized controlled trials have demonstrated, whereas a half-dozen studies combined show pomegranates, a fruit packed with anthocyanin pigments, can bring down inflammation over time.
What about adding spices to meals as an approach to cool down inflammation? Supplementation with grape and turmeric extracts did not affect the inflammatory response to a milkshake. But giving people one teaspoon a day of actual turmeric—that is, the whole spice, not purified curcumin supplements—resulted in a significant drop in IL-6 levels.
Garlic powder reduced IL-6 levels as well, starting at about half a teaspoon a day. Ginger powder (ground ginger) had the same results with doses ranging from half a teaspoon to one and a half teaspoons.
Of course, another way to mediate the inflammation caused by a Sausage and Egg McMuffin is to not eat it in the first place. What about just eating a plant-based diet? To my surprise, the drop in IL-6 did not reach statistical significance. Whenever a dietary intervention doesn’t have the result you expect, you always have to ask, “What exactly was the diet they actually ate?” The study mostly looked at the Mediterranean diet, which certainly has more plants, but maybe the diets didn’t go far enough? For more clarity, we turn to Dr. Turner-McGrievy’s famous New DIETs study, where people either continued to eat their fully omnivorous diets or were randomized to eat a vegan diet, a vegetarian diet, a pesco-vegetarian diet, or a semi-vegetarian diet that, for example, limited red meat. So, whereas the vegan might eat red beans and brown rice with chopped tomatoes and roasted peppers for dinner, the vegetarian might add some cheese, the pesco-vegetarian might add shrimp, and the semi-vegetarian might add some turkey sausage. Below is a more in-depth look at the five diet patterns, which you can also see at 4:01 in my video.
What happened within two months to their Dietary Inflammatory Index scores? The Dietary Inflammatory Index is a measure of how inflammatory your diet is. Negative scores mean your overall diet is anti-inflammatory, and the lower, the better, whereas positive scores mean your overall diet is on balance pro-inflammatory, which is exactly where the people in the study started. That comes as no surprise, given that they were eating regular diets and our nation is awash with inflammation-related disease.
But when the study participants switched to strictly plant-based nutrition, their diet flipped to become an anti-inflammatory diet. That was the case even if they just cut out meat or all meat except fish. But if they instead switched mostly to poultry or only limited their meat intake, their diet remained inflammatory. You can see the results below or at 4:47 in my video.
Now, not all plant foods are anti-inflammatory. If all you do is boost your intake of less healthy plant foods, like juice, white bread, white potatoes, soda, and cake, you can end up even more inflamed. But if you eat a really clean diet of whole plant foods, you get significant reductions in lipoprotein(a)—Lp(a)—which we didn’t even think was possible with diet—as well as drops in LDL cholesterol and even the most dangerous form of LDL cholesterol. Also, nearly across the board, you get a drop in inflammatory markers; we’re talking a 30% drop in C-reactive protein and a 20% drop in IL-6. So, maybe previous studies with plant-centered diets were unsuccessful because they weren’t plant-based enough, with animal products still being substantially consumed. Therefore, the total “elimination of animal products and processed foods…may be a more prudent dietary strategy” to combat inflammation.
Sleep is not just downtime for the body; it is active maintenance time for the brain. The relationship between sleep and brain health shapes how well a person can think, focus, manage emotions, and remember important information.
Research in sleep memory science shows that during sleep, the brain replays, organizes, and stores experiences from the day, turning short-term impressions into more stable memories. Understanding how sleep and brain health interact explains why good rest is essential for learning, performance, and long-term cognitive wellbeing.
The Science of Sleep and Brain Health
Sleep and brain health are tightly linked through the different stages of sleep that repeat in cycles through the night.
During non-rapid eye movement (NREM) sleep, especially deep slow‑wave sleep, brain activity slows, energy is restored, and waste products are cleared. In rapid eye movement (REM) sleep, brain activity becomes more dynamic, supporting emotional processing and creativity.
Sleep memory science suggests these stages work together to protect neurons, balance brain chemicals, and maintain healthy brain networks.
While a person sleeps, the brain trims weaker connections, strengthens important ones, and supports the structure needed for clear thinking and a stable mood. When sleep is too short or fragmented, this nightly “maintenance” is less effective.
Sleep Stages, Memory, and Brain Health
The link between sleep and brain health is especially clear in memory formation. Deep NREM sleep helps consolidate factual information, such as what someone studies, reads, or practices during the day. The brain replays recent experiences and begins transferring them from short-term storage toward longer-term networks.
REM sleep is closely tied to emotional memories, creative insight, and problem-solving. In this stage, the brain combines new information with older memories, helping people make sense of experiences and form new ideas. Cycling through all sleep stages several times each night allows memory systems to work smoothly.
Types of Memory in Sleep Memory Science
Sleep memory science often focuses on three main types of memory:
Declarative memory: facts, concepts, and information (such as vocabulary, dates, or formulas).
Procedural memory: skills and habits (such as playing an instrument or refining a sport technique).
Emotional memory: how events feel and how the brain tags certain experiences as important or threatening.
All three rely on healthy sleep and brain health. Deep sleep tends to support declarative and skill memories, while REM sleep helps process emotional and creative content. When sleep is shortened or low quality, people may forget details more easily, perform learned tasks less smoothly, and feel more emotionally reactive.
Benefits of Healthy Sleep for Brain Health
Good sleep supports sharper focus, better concentration, and more reliable attention. A well‑rested brain absorbs new information more easily and stays organized under pressure. Decisions tend to be clearer, reaction times quicker, and mental flexibility stronger when sleep patterns are consistent.
Sleep and brain health also shape mood and emotional resilience. With enough sleep, the brain is better able to regulate stress and prevent minor frustrations from feeling overwhelming.
Over time, healthy sleep habits are linked with a lower risk of cognitive decline and some neurodegenerative conditions, making sleep a key pillar of long‑term brain protection.
Short‑Term Effects on Thinking and Memory
Even a single night of poor sleep can change how the brain functions the next day. Many people notice brain fog, slower thinking, difficulty concentrating, and reduced accuracy. Tasks that require sustained attention, such as driving, studying, or detailed work, become harder.
Sleep memory science shows that restricted sleep makes it more difficult to move information from short‑term to long‑term storage. New material feels harder to remember, and previously learned facts may be harder to recall. This is why staying up late to cram often results in feeling unprepared and forgetful.
Long‑Term Effects on Sleep and Brain Health
Chronic sleep loss can gradually disrupt sleep and brain health in more serious ways. Long‑term insufficient sleep is linked to a higher risk of anxiety, depression, and burnout, as the brain struggles to balance stress and mood.
Over time, ongoing poor sleep may affect brain structure and connectivity, which in turn influences memory and thinking.
Research in sleep memory science also points to an association between long‑term poor sleep and increased risk of cognitive decline. When the brain does not get enough deep sleep, it may clear waste products less efficiently and struggle to maintain healthy cells, which can affect how the brain ages.
Sleep Memory Science in Everyday Life
The role of sleep and brain health appears clearly in everyday situations. Students who study and then sleep typically recall more than those who stay up late revising the same material.
Athletes often perform better and learn new techniques more quickly when adequate sleep is part of training, because the brain refines motor patterns during the night.
Professionals who prioritize sleep frequently find they think more clearly, solve problems faster, and generate better ideas. Sleep memory science also supports the idea of “sleeping on it” before making big decisions. By processing information overnight, the brain often produces clearer insight by morning.
Habits That Support Sleep and Brain Health
Certain daily habits can significantly support sleep and brain health. Keeping a consistent sleep and wake time, even on weekends, helps stabilize the body’s internal clock. A sleep‑friendly environment, cool, dark, and quiet, encourages deeper, more restorative rest.
Limiting screens, caffeine, nicotine, and heavy meals in the hours before bed reduces stimulation that interferes with falling asleep.
Calm routines such as light reading, gentle stretching, or relaxation breathing can signal to the brain that it is time to wind down. Over time, these practices strengthen healthy sleep patterns, improving thinking, mood, and memory.
When to Seek Help for Sleep Problems
Sometimes, ongoing sleep difficulties reflect an underlying sleep disorder that affects sleep and brain health.
Signs that it may be time to seek help include regularly taking a long time to fall asleep, waking often during the night, loud snoring with gasping or pauses, or feeling very tired despite spending enough hours in bed. These may point to conditions such as insomnia, sleep apnea, or restless legs syndrome.
Speaking with a healthcare provider or sleep specialist can lead to proper evaluation and treatment. Addressing sleep problems early supports sleep memory science in action and protects long‑term brain function.
Prioritizing Sleep and Brain Health for Stronger Memory
Treating sleep as a core part of health gives the brain what it needs to function at its best. Solid evidence from sleep memory science shows that sleep strengthens learning, stabilizes mood, and protects cognitive abilities over time.
For anyone noticing ongoing issues with focus, mood, or memory, examining sleep habits is a powerful starting point. By prioritizing sleep and brain health, people build a stronger foundation for clearer thinking, more reliable memory, and healthier aging.
Frequently Asked Questions
1. Can improving sleep help with learning a new language?
Yes. Deeper, more consistent sleep helps the brain consolidate vocabulary, grammar, and pronunciation, making new language skills stick more effectively.
2. Is it better to sleep right after studying or take a break first?
Short breaks are helpful, but sleeping within a few hours of studying usually gives the strongest boost to memory consolidation.
3. Do early birds and night owls benefit differently from sleep for memory?
Both do. The key is getting enough high‑quality sleep in line with their natural rhythm, not the exact clock time they sleep.
4. Can changing my bedtime by an hour really affect memory?
Yes. Even small, consistent shifts that reduce total sleep time can gradually weaken focus, learning efficiency, and memory performance.
The FDA has not approved a new generalized anxiety disorder treatment since 2009. With a high placebo effect, complex neurobiology, and a long list of failed candidates, GAD represents one of psychiatry’s most persistent clinical challenges. Here is what the data shows, and how precision trial design is finally shifting the odds.
The Gap in the Market
Generalized Anxiety Disorder affects an estimated 6.8 million adults in the United States alone, yet the last drug to receive FDA approval specifically for the condition was pregabalin, cleared in 2009. Since then, psychiatry has cycled through a series of promising candidates that ultimately could not clear the regulatory bar, leaving clinicians relying on a toolkit that is now a decade and a half old.
The treatment gap is not for lack of scientific interest. It reflects a specific set of structural challenges: GAD’s biological complexity, the outsized placebo response typical of anxiety trials, and the rigorous endpoint standards that the FDA has maintained. For US biotech firms eyeing this space, the challenge is real, and so is the opportunity.
The last FDA-approved GAD therapy was cleared in 2009. The biology has not changed. The trial methodology has.
What Makes Gad Difficult to Treat
GAD is characterized by persistent, excessive worry about everyday matters that causes measurable functional impairment. Unlike discrete phobias or panic disorder, it is diffuse, chronic, and deeply intertwined with both neurobiological and psychological systems.
The neurochemical picture is complex. GAD is associated with dysregulation across multiple transmitter systems, including serotonin, norepinephrine, and gamma-aminobutyric acid (GABA). Early drug development concentrated heavily on GABA-targeting compounds. The results were largely disappointing, reinforcing what researchers now recognize: single-pathway interventions tend to fall short in a condition this multifactorial.
Genetics plays a partial role. Heritability estimates for GAD sit around 30%, a figure high enough to justify genetic research targets, but low enough to confirm that environmental and psychological factors remain significant contributors. That complexity creates both a challenge for trial design and an argument for individualized treatment approaches.
The diagnostic framework has evolved. Under DSM-5 (code 300.02 / F41.1), GAD requires excessive anxiety and worry occurring more days than not for at least six months, with the individual finding the worry difficult to control. The ICD-11 (code 6A71) similarly emphasizes persistent, excessive worry across multiple activities. For trial sponsors, precision in patient selection using these criteria is not just a clinical formality; it directly affects outcome data.
The Six FDA-Approved Treatments: A Historical Snapshot
Six drugs have received FDA approval for the treatment of GAD. The timeline tells a story about where science has concentrated and where it has plateaued.
Drug
FDA Approval
Mechanism / Notes
Buspirone
1986
Anxiolytic targeting serotonin receptors; distinct from benzodiazepines
Paroxetine
2001
SSRI; commonly prescribed where depression co-occurs with GAD
Escitalopram
2002
SSRI with demonstrated efficacy across GAD and major depressive disorder
Duloxetine
2007
SNRI; covers GAD, major depressive disorder, and neuropathic pain
Venlafaxine
2008
SNRI; used across GAD, depression, and panic disorder
Pregabalin
2009
Originally an anticonvulsant; adopted for GAD based on CNS calming effects
The six approved agents cluster around SSRIs and SNRIs, with buspirone representing the only serotonin-specific anxiolytic and pregabalin the lone anticonvulsant-class entry. No novel mechanism has made it to approval in the 16 years since. The reasons lie partly in the drugs that did not make it.
Lessons from the Failures: Five Candidates That Could Not Cross the Line
Analyzing failed drug development is as instructive as studying successes. The last decade of GAD trials has produced a consistent set of failure patterns that inform how new trials should be designed.
Candidate
Primary Failure Mode
Detail
Tofisopam
Limited Efficacy
Failed to outperform placebo in large-scale trials
Esmirtazapine
Discontinued
Development halted on strategic grounds despite promising early data
Gepirone ER
Insufficient Efficacy
Did not meet primary efficacy endpoints
Fasoracetam
Inconclusive
Lacked a clear efficacy signal in GAD-specific trials
PF-06372865
Safety & Efficacy
Development halted over safety concerns and insufficient trial performance
Several themes recur across these failures. Limited sample sizes produced underpowered results. Short trial durations missed the chronic nature of GAD’s trajectory. And the placebo response in anxiety studies is structurally higher than in most other therapeutic areas, which means that even moderately effective compounds can appear statistically indistinguishable from inactive controls if the trial is not designed to account for it.
There is also a financial dimension. The cost and risk profile of CNS drug development has led multiple pharma organizations to redirect resources toward indications with clearer regulatory pathways. That dynamic has left an opening for lean, well-organized biotech firms to move into GAD with more focused programs and lower overhead structures.
The placebo response in anxiety trials is structurally higher than in most other therapeutic areas. A trial not designed to account for this will produce misleading results regardless of the compound’s actual efficacy.
What High-Quality Gad Trial Design Actually Requires
The FDA’s standards for GAD are not ambiguous. What has proven difficult is executing against them consistently. Based on the available evidence from failed candidates, successful trial design in this indication requires attention to five interconnected variables.
Patient selection precision. Rigorous application of DSM-5 and ICD-11 criteria at enrollment is foundational. Trials that use loose inclusion criteria or fail to screen out comorbid conditions with overlapping symptom profiles inflate variance and obscure the treatment signal.
Appropriate outcome measures. The Hamilton Anxiety Rating Scale (HAM-A) remains the primary FDA-recognized endpoint for GAD, but it functions best when paired with secondary measures that capture patient-reported experience. Reliance on a single endpoint has contributed to approval failures even when a partial clinical benefit was observable.
Managing the placebo effect. GAD trials consistently show placebo response rates that make separation from active treatment difficult to demonstrate. Strategies including optimized rater training, centralized assessment protocols, and blinding procedures are not optional enhancements; they are structural requirements for generating reliable efficacy data.
Safety monitoring infrastructure. Several failed candidates ran into safety signals that might have been identified and managed earlier with more granular pharmacovigilance protocols. Real-time safety oversight reduces the risk of late-stage discontinuation.
Regulatory alignment from day one. FDA engagement during trial design, not after data collection, is one of the most consistent differentiators between programs that advance and those that do not. Pre-IND consultation, alignment on endpoint selection, and documented regulatory strategy significantly reduce the probability of a complete response letter.
The iNGENu CRO Approach to Gad Research
iNGENu CRO is an Australian-headquartered clinical research organization built specifically to support early-to-mid-stage biotech firms pursuing FDA approval. In GAD and broader psychiatric indications, the organization brings several structural advantages that address the failure patterns described above.
FDA-compliant data from non-US trials. iNGENu’s Australian trial infrastructure generates data under 21 CFR 312.120 compliance, meaning results from Asia-Pacific trials can be submitted directly to the FDA without the need for a US IND at the early-phase stage. This shortens start-up timelines to as little as eight to twelve weeks for Phase 1 and 2 programs.
Physician-led trial execution. Sponsors engage directly with iNGENu’s medical and scientific leadership, including its Chief Executive Officer and PhD scientists, from the start of the engagement. This reduces the communication overhead that leads to protocol drift in larger CRO structures.
Cost structure aligned with biotech economics. Through the Australian Government’s 43.5% R&D Tax Incentive, eligible sponsors can recover a significant portion of trial expenditure as a direct cash refund. iNGENu reports that more than 99% of its clients qualify for this program. For early-stage firms managing tight capital structures, the cost differential can be decisive.
Validated psychiatric trial infrastructure. iNGENu operates dedicated clinical capabilities in psychiatric disorder research, with assessment instruments, rater training protocols, and patient-centered design features suited to the specific demands of GAD and related anxiety conditions. This infrastructure directly addresses the endpoint measurement and placebo management challenges that have historically contributed to trial failures in this space.
Sponsors engage directly with iNGENu’s medical and scientific leadership from the start of the engagement. This structure reduces the communication overhead that causes protocol drift.
The Market Case for Moving Now
The commercial argument for GAD drug development is straightforward. Prevalence is high, existing treatments have significant tolerability and efficacy limitations, and there has been no new approved mechanism in the indication since 2009. For a US biotech capable of demonstrating meaningful separation from placebo on validated endpoints, the market entry would be entering largely uncrowded territory.
The parallel shift toward personalized medicine approaches in psychiatry also creates an opening for novel mechanisms. Multi-target drugs, biomarker-stratified patient selection, and next-generation pharmacological approaches are all areas where early-stage investment today could translate to a differentiated regulatory position within a realistic development timeline.
iNGENu CRO’s whitepaper on generalized anxiety disorder clinical endpoints, FDA approvals, and trial enhancements maps this landscape in detail for sponsors actively evaluating GAD as a program priority. The document is available directly through iNGENu CRO and covers diagnostic criteria, clinical endpoints, historical approval and failure analysis, and the firm’s approach to trial design.
Conclusion
GAD drug development has not stalled because the patient’s need is unclear. It has stalled because the trial execution demands are high and the consequences of methodological shortcuts are severe. The programs most likely to succeed in this space will be those that approach the design phase with the same rigor they bring to the molecule itself.
With the FDA’s endpoint standards well established, the biological rationale for novel mechanisms documented in the literature, and a cost-accessible clinical infrastructure available through Australia’s regulatory pathway, the conditions for a new wave of GAD approvals are better than they have been in years. The question for sponsors is whether their trial architecture is capable of delivering on the opportunity.
BOOK A DISCOVERY CALL WITH iNGENu CRO
iNGENu CRO provides high-quality, FDA-compliant clinical research for innovative biotech firms. To discuss your GAD or psychiatric clinical trial program, contact the team directly: Email: hello@ingenucro.com Website: www.ingenucro.com
All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.
The Empowerment Package is backed with a 60 Day No Questions Asked Money Back Guarantee. If within the first 60 days of receipt you are not satisfied with Wake Up Lean™, you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.
If you find you often react without thinking, explore this practice to respond with greater awareness.
Daily life is full of irritations: moments of inconvenience, situations where we don’t get what we were hoping for, delays, disappointments, prickly interactions that can leave us confused and exasperated.
If we’re honest, we can probably admit that sometimes our reactions in those moments tend to be reflexive rather than intentional. We feel our anger or annoyance rise, and we react almost as though we’re reading a script.
Can we explore these habitual reactions in a way that gives us enough space to respond differently? In today’s practice, teacher Patricia Rockman guides us through a meditation to help us meet whatever is arising, so that we have more agency when the next moment arises.
This meditation is about working with habits. In particular, our habitual reactions to difficult situations that commonly arise. These could be anger at being stuck in traffic, sadness at not getting what you want, or frustration when dealing with companies that keep you on hold for what feels like eternity. Whatever it may be, whether it is something significant or something that might seem mundane, mindfulness practices can help us deal with our habitual reactivity in more skillful ways.
A Meditation to (Gently) Interrupt Habitual Reactions
Read and practice the guided meditation script below, pausing after each paragraph. Or listen to the audio practice.
Get into a comfortable posture, one that is familiar to you and that you use when engaging in a practice, and bring attention to your body. If you are sitting, bring attention to your points of contact; where your sitting bones are on your chair or cushion, or where your feet or legs are in contact with the surface.
Bring attention to where your hands are in relation to your body, whether they are resting on your thighs or folded in your lap. Bring attention to your chest rising, your chin in line with your navel, and your tongue at rest behind your teeth. If you are choosing to lie down for this practice, it is preferable for you to lie on your back.
Bring attention to your body as it makes contact with the mat, floor, or bed. Note your points of contact, and also note where your body is not in contact. Whatever your position, allow the surface that you are lying or sitting on to take on the work of holding you up. Bring attention to the front body and the back body, and everything in between.
Now shift your attention to the sensations of breathing where they are most readily available, whether at the nostril, the chest, or the abdomen. Really hone in on the sensations of the breath as they make themselves known to you, picking one place and resting your attention there.
Attend to the in-breath and the out-breath. Attend to the movement of the body as the air moves in and out. Attend to the nostrils; you may be noticing the coolness of the air as it goes in, and the warmth as it moves out. Attend to the breath or the chest, focusing on the expansion of the body with the in-breath, and the deflation of the body as the breath leaves.
Allow the body to settle. Allow the breath to settle. Breathe in, breathe out, breathe in, breathe out. Each breath is a new breath. Each breath is a receiving and a releasing.
You will notice from time to time that your attention will move into thinking, into the future, past, planning, anxiety, or daydreaming. Your task is simply to notice this habitual tendency of mind, and gently return to your breath over and over again, without judgment and without a story. There is no right or wrong here, there is simply attending to your breath, noting when your attention moves, and bringing it back again.
Notice when the breath is low, and when the breath is short. Notice when it is shallow, and when it is deep. Mindfulness is about coming to know our experience in its entirety, whether wanted or unwanted, and in this case it is coming to know the experience of breathing.
Breathe out and let go of this primary focus on the breath, and allow it to be present but in the background. On an in-breath, establish attention in your entire body. Bring an open receptivity to experience and to sensations in the body as they come and go. Note their arrival, persistence, or passing, and explore these. Bring a friendly interest and curiosity to this investigation of the sensorial nature of experience, whatever it is.
Notice how your body feels. There may be ease, tension, relaxation, discomfort, or pain in a part of your body. Whatever it is, when a sensation calls out for attention, investigate it and explore its depth and various qualities. Whether you lean into it or lean away, whether it is pleasant, unpleasant, or even neutral, without changing anything in this moment, simply attend to what is arising in your body as it shows.
Attend to what is arising as best as you can and without judging it, but notice judgment or aversion if they do arise. As best as you can, explore the sensation as it is, without judgment.
Investigate sensations as they arise. Once you are finished investigating one sensation, wait for another to arise and investigate that one. Remember that a sensation may be internal or external. Perhaps sounds are making themselves known as they come and go. Get to know your bodily sensations, in your body, in this moment.
Note when your attention moves into thinking, or you feel an impulse to act or shift position. Acknowledge that this is what is here right now. Turn your attention back to your body, over and over again. Explore one sensation, let go of it, and then bring your attention into another as it enters your awareness.
Now, if you want to, bring to mind a manageable stressful situation. Maybe it’s a recent time when you were irritated, sad, confused, or anxious. Perhaps it was a situation in a relationship or at work. Bringing to mind this situation, remember that if what comes up is at all overwhelming for you, feel free at any time to turn your attention back to breathing with your body.
If your eyes are closed, open them. Consider a stressor and note what arises immediately. It could be a bodily sensation, a thought, or an emotion. Perhaps there is a behavior or an impulse to act. Start to get to know your stress reactivity signatures.
If there are thoughts, observe them as best as you can. If there are emotions, try naming them, such as “sadness”, or “anxiety”. Remember that labeling emotions helps to settle them and make them more manageable. Labeling emotions creates an opportunity to give you a choice about what happens next.
If there are body sensations, make a note of these, and actually turn your attention to them. Explore them even if they’re unwanted. Get to know them. Stay with them for as long as they are holding your attention. Note whether they increase, persist, or fade. Recognize that this is a moment of stress, and that it’s ok; it’s already here. Bring a compassionate and kind holding to this experience. Be with it as it is, even though it may be unwanted. Explore your body and the sensations for as long as they’re here.
Now, shift your attention back to the sensations of breathing, perhaps in your belly. If there are any remaining sensations, hold attention at the same time. Engaging in the option, should you choose, to expand into these on the in-breath, softening, expanding, and releasing on the out-breath, letting go, or allowing and letting be, if this is possible. If this is not necessary, then simply bring attention to the belly and the rising and falling of the breath that comes and goes.
Expand around the breath to the entire body once again, to any and all sensations. Be with the body, with your breathing in the background and sensations in the foreground, from head to toe. Bringing a feeling of spaciousness to your experience; be open and receptive, with an open front and strong back.
When you’re ready, let go of this practice, and if possible bring a more expanded and spacious awareness to your next moments.
Now, if you feel inclined, take a paper and pen and write down any words, thoughts, emotions, bodily sensations, and impulses to act that came to mind. Write down what came up for you in that practice when you introduced the stressor. Name the emotions, and listing them. What bodily sensations and what impulses to act or behaviors, if any, went through your mind? These components of experience may show themselves in a variety of ways, moving from thoughts, to emotions, to bodily sensations, to behaviors, and back to emotions and thoughts, and that’s OK. Record these as they show up to you.
Once you’ve finished, take a moment to look at what you’ve written and think about where in your habitual reaction you might intervene with mindfulness. How might you bring awareness to these habitual reactions when they arrive, to provide more choice if this is needed, or to introduce other options about how to respond? How might you stop yourself, to be able to take a step back and gain perspective?
Bring Mindful Attention to Habitual Reactions
Perhaps make a commitment to yourself about how you might practice with this in some small way when difficulty arises. Perhaps once a week or once a day, simply bring mindful attention to an experience, or bring the breath your mind when difficulty shows, or shift an attitude, or engage in a different behavior.
Whatever you may do, remember that awareness is always a moment away, and mindfulness is portable it can be with us wherever we are, in any moment, at any time.
Unchecked stress may lead to overwhelm, unhelpful coping, and burnout. When you learn to recognize the warning signs, you can take wise action to manage your stress—with a little kind attention, and a lot of self-compassion. Read More
Inflammatory markers can double within six hours of eating a pro-inflammatory meal. Which foods are the worst?
Excessive inflammation may play a role in a number of leading causes of death and disability, including type 2 diabetes, obesity, and heart disease. “But what are the stimuli that jumpstart the destructive inflammatory cascade?” You typically hear about the pro-inflammatory nature of a chronic high-fat diet, but the inflammatory effect “may not be limited to chronic intake but may be evident after the consumption of a single meal.”
Within hours after eating an unhealthy meal, inflammatory markers like interleukin-6 (IL-6) can skyrocket, doubling within six hours. The majority of studies show an increase in IL-6 after consuming a high-fat meal. But the meals they tested weren’t just filled with meat, eggs, dairy, and oil, but also junky refined carbohydrates like white flour and added sugar.
When people are given essentially straight butter fat and no carbs, they can still get a spike in inflammation within hours, proving the added fat itself is pro-inflammatory. But when people are given straight sugar water without any fat, the result is the same, proving the added sugar is pro-inflammatory, too, as you can see below and at 1:26 in my video Foods That Cause Inflammation.
Why should we be concerned with the inflammatory responses after unhealthy meal ingestion? Because extensive research points to the idea that “persistent low-grade inflammation is an underlying factor in several high-mortality chronic diseases and that diet can contribute to, or attenuate, that inflammation.”
You’ll note in the graph below that IL-6 levels jumped up to about 3 pg/mL after the meal. (You can also check it out at 1:55 in my video.)
When levels start regularly getting up to about 3 pg/mL, that’s associated with twice the risk of death. That increased risk was found across the board, compiling eight other similar studies, likely because it’s linked with increased risk of heart disease, the number one killer of men and women, even as strongly as some other major well-known risk factors like high cholesterol.
Now, not all high-fat foods cause inflammation. More than a dozen studies combined show that whole plant foods such as nuts do not increase inflammatory markers, even when eating up to handfuls of nuts a day. In fact, spread half an avocado on a beef burger, and you may be able to blunt some of the inflammation caused by the meat—even lean meat—as you can see below and at 2:35 in my video.
There are reviews purporting to show a drop in inflammatory markers after eating wild game, which is about as lean a meat as you can get, but that’s only compared to store-bought meat. Give people some really fatty meat and their IL-6 shoots up, as do their tumor-necrosis factor and C-reactive protein. Inflammatory, inflammatory, inflammatory—within hours of consumption. But what if you instead eat a kangaroo steak, which is extremely low in fat, similar to elk or moose? You’ll get the same strong inflammatory response within hours of eating it, as you can see below and at 3:15 in my video.
Now, certainly less inflammatory than conventional meat you might get at the store, but pro-inflammatory nonetheless, increasing markers of inflammation within mere hours.
Intermittent fasting has gained attention as a flexible way of eating that may support weight management, metabolic health, and overall well-being, and many people look for clear information on intermittent fasting benefits. This article explains how intermittent fasting works, the main potential benefits, and the key risks to consider.
What Is Intermittent Fasting and How Does It Work?
Intermittent fasting is an eating pattern that alternates between periods of eating and voluntary fasting, focusing on when to eat rather than exactly what to eat. Common methods include the 16:8 approach (16 hours fasting, 8 hours eating), the 5:2 method (regular eating five days a week and reduced intake on two days), and alternate‑day fasting.
The aim is to extend the time between meals so the body relies more on stored energy, particularly fat, for fuel.
During a fast, insulin levels fall and the body shifts from using glucose from recent meals to using stored fat more heavily.
Hormonal and cellular changes, including increased release of certain stress hormones and activation of repair processes, are thought to underlie many intermittent fasting benefits. Responses vary from person to person, depending on health status, lifestyle, and diet quality.
What Are the Main Intermittent Fasting Benefits?
Intermittent fasting benefits often discussed in research include modest weight loss, improved metabolic markers, and better structure around eating times. Many people naturally reduce calorie intake when eating is limited to a defined window, which can support gradual weight loss and help some individuals avoid constant snacking.
These effects are usually stronger when fasting is combined with nutrient‑dense, minimally processed foods.
Studies also suggest that intermittent fasting can improve certain markers such as blood sugar, insulin sensitivity, blood pressure, and cholesterol in some individuals.
However, these improvements often occur alongside other changes, such as more mindful food choices and increased physical activity. The overall lifestyle pattern, not just the fasting schedule, plays a major role in the magnitude of intermittent fasting benefits.
Can Intermittent Fasting Help with Weight Loss?
Weight loss is one of the most commonly reported intermittent fasting benefits. By shortening the daily eating window or reducing intake on specific days, many people consume fewer calories without strict tracking.
This can encourage the body to draw more on stored fat, especially when combined with balanced meals and adequate protein during eating periods, according to Johns Hopkins Medicine.
When compared with traditional daily calorie restriction, intermittent fasting tends to produce similar average weight‑loss results across studies. The main difference is often practicality and personal preference.
Some individuals find time‑based rules easier to follow than counting calories, while others may struggle with long fasting stretches and feel better with smaller, more frequent meals.
How Does Intermittent Fasting Affect Blood Sugar and Insulin?
Intermittent fasting benefits may include improvements in blood sugar control and insulin sensitivity, particularly in individuals with overweight or prediabetes.
Fasting windows give the body breaks from frequent glucose intake, which can help lower fasting blood sugar levels and improve how cells respond to insulin. This may reduce the risk of developing type 2 diabetes in some people.
However, individuals taking medications that lower blood sugar, such as insulin or certain tablets, face a higher risk of low blood sugar during extended fasts.
For them, experimenting with intermittent fasting benefits should only happen under medical supervision, and in some cases fasting may not be appropriate. Close monitoring and possible adjustment of medication are essential if a fasting pattern is introduced.
Is Intermittent Fasting Good for Heart and Brain Health?
Research indicates that intermittent fasting benefits may extend to heart health markers. Some studies report reductions in blood pressure, LDL cholesterol, triglycerides, and inflammation when fasting is combined with a generally healthy diet.
These changes, if maintained, could help lower long‑term cardiovascular risk, although more long‑term trials are needed.
There is also growing interest in intermittent fasting benefits for brain health and healthy aging. Fasting appears to stimulate cellular repair processes and may support resilience against certain age‑related changes, based largely on animal and early human studies.
While these findings are promising, evidence in humans over many years is still limited, so brain and longevity benefits are best viewed as potential rather than guaranteed outcomes, as per Harvard Health.
What Are the Possible Risks and Who Should Avoid It?
Alongside potential intermittent fasting benefits, there are clear risks and side effects. Common issues include hunger, headaches, low energy, irritability, and reduced concentration, especially when someone first starts or chooses an overly aggressive schedule.
Some may overeat during eating windows or gravitate toward calorie‑dense, low‑nutrient foods, which can cancel out benefits and cause discomfort.
Intermittent fasting is not recommended for everyone. Individuals with a history of eating disorders or disordered eating patterns, those who are underweight, pregnant or breastfeeding people, children, and teenagers are generally advised to avoid structured fasting.
People with diabetes or other blood sugar disorders, particularly those on medication, should only consider fasting under careful medical guidance, if at all. In these groups, potential risks often outweigh intermittent fasting benefits.
Is Intermittent Fasting Safe Long-Term and How Can Someone Start?
Long‑term data on intermittent fasting are still emerging, and most studies last weeks or months rather than years. Some people maintain intermittent fasting benefits and feel well over time, while others notice increased stress, fatigue, or social disruption.
Regular health check‑ups, blood tests, and honest self‑assessment are important for anyone following a fasting pattern for the long term.
For those who wish to explore intermittent fasting benefits, starting slowly is often more comfortable. Extending the overnight fast by one or two hours and gradually moving toward a consistent pattern like 12:12 or 14:10 can help the body adjust.
Emphasizing whole foods, staying hydrated, prioritizing sleep, and paying attention to mood and energy can make the experience safer and more sustainable. If persistent negative symptoms appear, it may be a sign that another eating approach is more suitable.
Benefits of Intermittent Fasting
Intermittent fasting benefits can include weight loss, better metabolic markers, and possible advantages for heart and brain health, but they depend strongly on the individual and the overall lifestyle surrounding the fasting pattern.
The approach requires thoughtful planning, realistic expectations, and awareness of who should avoid it or proceed only with medical support.
For those who are good candidates and find the structure manageable, intermittent fasting can serve as one potential tool among many for supporting health, as long as decisions are guided by personal needs, evidence‑based information, and professional advice when needed.
Frequently Asked Questions
1. Can someone drink coffee or tea during intermittent fasting?
Yes, unsweetened black coffee, plain tea, and water are generally allowed during fasting windows, as long as they contain no sugar, cream, or milk that would meaningfully add calories.
2. Does intermittent fasting slow down metabolism over time?
Short- to moderate-term intermittent fasting typically does not slow metabolism and may temporarily increase it slightly, but extreme or prolonged calorie restriction can reduce metabolic rate in some individuals.
3. Can intermittent fasting be combined with intense exercise?
It can be, but many people feel better scheduling intense workouts during or near their eating window to support performance, recovery, and adequate protein and calorie intake.
4. How long does it take to notice intermittent fasting benefits?
Many people report changes like reduced snacking and slight weight shifts within a few weeks, while more significant changes in markers like blood sugar or cholesterol may take several months of consistent practice.
The construction industry experiences the highest frequency of fall-related deaths. These deaths are mostly falls from heights.
The highest counts of nonfatal fall injuries are in the educational and health services and the healthcare and social assistance industries. These injuries are mostly slips and falls on the same level.
Other industries at high risk of fall injuries include:
Nursing and residential care
Ambulance services
Building cleaning and maintenance
Transportation and material moving
Fact
In 2020, 805 workers died from falls.1 211,640 suffered severe injuries requiring days away from work in the private industry.2
Impacts
Fall injuries create a considerable financial burden. In the United States, workers’ compensation and medical expenses associated with workplace falls are estimated to cost $70 billion annually.3
Other countries face similar challenges in the workplace. In fact, the international public health community has a strong interest in developing strategies to reduce fall injuries.
National campaign to prevent falls
Falls are the number one cause of construction worker fatalities. The goal of the national campaign is to prevent fatal falls. Each year as part of the campaign, there is a National Stand-Down focusing on fall prevention.
Safety risks
Falls in the workplace frequently involve:
Unprotected edges
Unsafely positioned ladders
Misused fall protection
Water, grease, and other contaminants on the floor
Clutter and tripping hazards in walkways
Irregularities in the floor and wall openings
Prevention
Federal regulations and industry consensus standards provide specific measures and performance-based recommendations for fall prevention and protection. However, persistent unsafe practices and low safety culture across many industries define steady fall injury rates each year.
Reducing fall injury and death rates require:
Implementing new effective fall prevention and protection technologies
Using appropriate PPE like harnesses, fall guards, and slip-resistant footwear4
Improving the work safety culture by educating the workforce
These efforts require continued collaboration from:
Regulators
Industry leaders
Professional associations
Labor unions
Employers and employees
Safety professionals
Researchers
What CDC is doing
As a leader in occupational safety research, NIOSH plays a key role in these complex fall-injury prevention efforts. NIOSH bases fall-injury prevention research strategic planning and goal setting on:
The magnitude or emergence of the problem as shown by data
Immediacy of need
Resources and expertise available to work on the problem
Current research
Strength of partnerships
Status and momentum on research-to-practice efforts
Input from the National Academy of Sciences program review enhances the strategic planning process.
Resources
Fatality Assessment and Control Evaluation (FACE) Reports
Review Falls related NIOSH FACE and State FACE reports for recommendations to prevent similar deaths in CDC Stacks. View by Collection (NIOSH/FACE) or search for reports using keywords in the search bar.
More on falls
See the NIOSHTIC-2 database search results on falls. NIOSHTIC-2 is a database of occupational safety and health publications funded in whole or in part by NIOSH.
