Sleep Supplement for Sleep
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new sleep supplement to determine its impact on sleep quality. Participants will integrate the supplement into their routine for 30 days while maintaining their usual diet. The study will compare the supplement's effects on issues such as falling asleep and staying asleep. Those who have trouble sleeping, do not use sleep aids, and are willing to stop other supplements might be a good fit. Participants should live in the U.S. and be free from chronic sleep disorders or jobs that disrupt nighttime sleep. As an unphased trial, this study allows participants to contribute to early-stage research on improving sleep quality.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any supplements, medications, or over-the-counter products used to help with sleep during the study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that melatonin, a common ingredient in sleep aids, is generally safe for short-term use. Participants in clinical trials who took melatonin reported few side effects, similar to those who took a placebo (a harmless pill used for comparison). This suggests that most people tolerate melatonin well for short periods.
However, limited information exists on the long-term safety of melatonin. Some reports suggest potential heart risks with prolonged use, but more research is needed to understand these effects. Melatonin is available without a prescription, but the U.S. Food and Drug Administration (FDA) has not approved it as a treatment. This means its safety hasn't been tested as thoroughly as FDA-approved medications. Always consult a healthcare provider before starting any new supplement.12345Why do researchers think this study treatment might be promising?
The Sleep Supplement is unique because it offers a natural and potentially safer alternative to traditional sleep aids, such as prescription medications like benzodiazepines or over-the-counter options like antihistamines. While most sleep treatments work by targeting the brain's neurotransmitters to induce drowsiness, this supplement may utilize natural ingredients that align with the body's biological rhythms, potentially reducing the risk of side effects. Researchers are excited about this treatment because it promises a gentler approach to improving sleep quality, which could be particularly beneficial for individuals sensitive to conventional sleep medications.
What evidence suggests that this sleep supplement might be an effective treatment for sleep?
Research shows that the Sleep Supplement, which participants in this trial may receive, might help improve sleep quality. One study found that people taking a similar supplement slept better, fell asleep faster, and woke up less during the night. Another study discovered that ingredients like valerian and melatonin, often found in sleep supplements, helped with insomnia. Evidence also indicates that certain extracts can help individuals fall asleep quicker and increase deep sleep. Overall, previous studies suggest that sleep supplements could be beneficial for better sleep.678910
Who Is on the Research Team?
Philip Sapp, PhD, MS
Principal Investigator
Athletic Greens - AG1
Are You a Good Fit for This Trial?
This study is for healthy adults aged 25-59 with a BMI between 18.5 and 29.9, who have trouble sleeping but no uncontrolled chronic diseases. Participants must score ≤7 on the RU-SATED sleep scale, limit caffeine to ≤400 mg/day, avoid it after 2 PM, and not drink alcohol close to bedtime. They can't use other sleep aids or supplements during the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive interventional treatment and complete questionnaires for a total of 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sleep Supplement
Trial Overview
The trial tests a sleep supplement over 30 days in a randomized controlled setting. Participants will be randomly assigned to receive either the supplement or a placebo and will complete questionnaires about their sleep quality and morning wellbeing at different times.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Sleep Supplement
Usual Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Athletic Greens International
Lead Sponsor
Citations
Current Evidence on Common Dietary Supplements for ...
The supplement group exhibited enhanced sleep quality, reduced sleep latency, and decreased sleep disturbances. These improvements were ...
Over-the-counter products for insomnia in adults: A scoping ...
Most studied over-the-counter products improved insomnia symptoms in adults. Notably, valerian and melatonin are well-studied, and appear safe.
A better prescription for good sleep
A new Penn sleep study will test five popular sleep medications to give doctors better-informed treatment options.
Melatonin for the Treatment of Primary Sleep Disorders
Primary outcomes examined were improvement in sleep latency, sleep quality and total sleep time. Meta-regression was performed to examine the influence of dose ...
Rice bran extract supplement improves sleep efficiency ...
We previously reported that rice bran extract supplement (RBS) administration to mice decreased sleep latency and induced non-rapid eye movement (NREM) sleep.
6.
newsroom.heart.org
newsroom.heart.org/news/long-term-use-of-melatonin-supplements-to-support-sleep-may-have-negative-health-effectsLong-term use of melatonin supplements to support sleep ...
Melatonin supplements are promoted and marketed as a safe sleep aid; however, data demonstrating their long-term cardiovascular safety are ...
7.
mayoclinic.org
mayoclinic.org/healthy-lifestyle/adult-health/expert-answers/melatonin-side-effects/faq-20057874Melatonin side effects: What are the risks?
Melatonin is generally safe for short-term use. More research is needed to better understand its safety and usefulness over the long term. Unlike many sleep ...
Current Insights into the Risks of Using Melatonin as a ...
In the analysis of safety data from randomized, placebo-controlled trials, minimal adverse effects were reported with both melatonin and placebo ...
9.
baptisthealth.net
baptisthealth.net/baptist-health-news/long-term-use-of-sleep-supplement-melatonin-linked-to-potential-heart-risksLong-Term Use of Sleep Supplement Melatonin Linked to ...
While melatonin is often perceived as a safe, short-term sleep solution, there has been a lack of data on its long-term safety, especially ...
10.
health.ucdavis.edu
health.ucdavis.edu/blog/cultivating-health/melatonin-and-your-sleep-is-it-safe-what-are-the-side-effects-and-how-does-it-work/2025/02Melatonin and your sleep: Is it safe, what are the side ...
No. Melatonin is sold over the counter as a dietary supplement. These products are not approved by the U.S. Food and Drug Administration. As a ...
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