Nutritional Supplement for Sleep Quality
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new powdered sleep supplement to determine its effectiveness in improving sleep quality for individuals with mild sleep issues, such as difficulty falling asleep or waking during the night. Participants will receive either the supplement or a placebo (a harmless, inactive substance) to compare effects. It suits those who frequently struggle with sleep but lack diagnosed sleep disorders. Those dealing with these challenges and able to pause other sleep aids might find this trial a good fit. As an unphased trial, it offers a unique opportunity to contribute to research that could lead to new solutions for sleep issues.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any supplements, medications, herbal remedies, or over-the-counter sleep aids used to help with sleep for the duration of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the new powdered sleep supplement aims to improve sleep quality. Although detailed safety data for this specific supplement is not available, similar over-the-counter sleep aids containing ingredients like melatonin and magnesium have been well-researched. These ingredients are generally safe for most people.
Studies have found that melatonin can aid sleep without causing major side effects. Magnesium is also known to be safe and can promote relaxation and sleep. This suggests that the sleep supplement in the trial, which may contain similar ingredients, is likely safe.
However, if the supplement includes different or new ingredients, the safety information might be less clear. Since no specific reports of negative effects exist, it is reasonable to consider the supplement generally well-tolerated, based on the safety of its likely ingredients. Participants can discuss any concerns with the study team before joining the trial.12345Why are researchers excited about this trial?
Most treatments for sleep issues, like prescription medications or herbal remedies such as melatonin, work by altering sleep chemicals or hormones. But this novel powdered sleep supplement stands out because it offers a fresh, gentle approach by potentially enhancing sleep quality without relying on heavy pharmaceutical ingredients. Researchers are excited about its potential because it’s easy to consume as a powder, and it might provide a more natural alternative to traditional sleep aids. Additionally, the formulation aims to improve sleep without the side effects often associated with stronger medications, making it an appealing option for those seeking a milder, more holistic solution.
What evidence suggests that this novel sleep supplement could be effective for improving sleep quality?
Research shows that some ingredients in sleep supplements can improve sleep. For example, one study found that L-theanine, a common ingredient, helped people fall asleep 24 minutes faster and sleep 22 minutes longer. This suggests that supplements with similar ingredients might enhance sleep quality. In this trial, participants will receive either a novel powdered sleep supplement or a placebo. Although details about the new powdered sleep supplement are not available, ingredients like L-theanine have shown promising results in improving sleep.14678
Who Is on the Research Team?
Ellen O'Gorman
Principal Investigator
Citruslabs
Are You a Good Fit for This Trial?
Adults aged 35-65 with a BMI of ≥18.5 and ≤29.9 kg/m2, experiencing sleep issues but generally healthy, can join this trial. They must score ≤7 on the RU-SATED sleep questionnaire, limit alcohol before bedtime, caffeine to ≤400 mg/day and stop other sleep aids during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the novel sleep supplement or placebo for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Novel powdered sleep supplement
Trial Overview
The trial is testing a new powdered supplement versus a placebo in improving sleep quality for adults with minor sleep problems. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real supplement.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Novel powdered sleep supplement
Maltodextrin + Flavoring
Find a Clinic Near You
Who Is Running the Clinical Trial?
Athletic Greens International
Lead Sponsor
Citations
The Effects of a Nutritional Supplement on Sleep Quality
This study to assess the effect of a novel dietary supplement on sleep related outcomes. ... Dietary Supplement : Novel powdered sleep supplement ...
The effects of L-theanine consumption on sleep outcomes
Significant improvement in sleep onset latency (mean reduction −24 ± 25 min; p = 0.002); total sleep time (mean increase of 22 ± 32 min; p = 0.01) and sleep ...
Effect of a nutraceutical combination on sleep quality among ...
Mean PSQI decreased by 3.11 points (32.3%) in the active group, and by 3.86 points (39.5%) in the placebo group (p = 0.41). SF-36 increased more with placebo (+ ...
Dietary Supplement Interventions and Sleep Quality ...
Methods: We aim to systematically evaluate the efficacy of dietary supplement interventions in sleep quality improvement across populations with sleep disorders ...
A Series of Personalized Melatonin Supplement Interventions ...
However, our results show that melatonin supplements did not significantly improve sleep duration or sleep quality.
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.
Effects of a Novel Supplement on Sleep, Metabolism, Body ...
This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, ...
Bioactive blend developed for sleep quality
New research by The Company has shown that a specific proprietary bioactive blend can help to improve natural sleepiness and sleep quality.
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