A daily supplement duo aims to sharpen the mind and deepen sleep — a trial puts it to the test
NCT ID NCT07721506
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This 12-week trial tests whether a two-part dietary supplement system — a PM powder taken before bed and AM capsules taken with breakfast — can improve sleep quality, mood, mental clarity, and digestive comfort in generally healthy adults aged 18 to 65 who have trouble sleeping. Participants wear a Fitbit to track sleep and complete questionnaires remotely. The study is open-label and single-arm, meaning everyone gets the supplement and knows they are taking it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a dietary supplement system with a PM powder and AM capsules
- What this could lead to
- If it works, this could point toward a non-prescription option for improving sleep quality, mood, and mental clarity in generally healthy adults.
- What could go wrong
- This is a small, single-arm, open-label trial with no placebo group, so results may be influenced by the placebo effect. The supplement is not FDA-approved for these uses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and female adults aged 18 to 65 years. * Self-reports difficulty falling asleep, staying asleep, or having poor sleep quality overall, in the last 4 weeks. * Self-reports seeking support in at least one of the following domains: Difficulty switching off, perceived stress load, mental overload, next-day mental fatigue, reduced mental clarity or reduced cognitive readiness. * Generally healthy. * Willing and able to take the PM product (one serving mixed in water) in the evening and the AM product (two capsules with food) in the morning daily for 12 weeks. * Willing to maintain current diet, exercise, caffeine, alcohol, and sleep routines for the duration of the study. * Willing to wear a Fitbit continuously during the trial, and for 7 days prior to starting the test product. * Resides in the United States. Exclusion Criteria: * Known allergy or hypersensitivity to any ingredient in the test product. * Currently pregnant, breastfeeding, or trying to conceive, or will be during the study period. * Currently undergoing treatment for cancer, or have had a serious illness requiring hospitalization in the last 3 months. * Diagnosed severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, major depressive disorder requiring active treatment adjustment) that, in the judgment of the Investigator, would compromise participation or interpretation of results. * Diagnosed inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or other significant gastrointestinal condition requiring active management. * Current use of prescription antidepressants/anxiolytics, or other prescription neurologically-active medications that have been initiated or had a dose change within the past 90 days. * Current use of prescription sleep medications. * Regular use (i.e. more than once per week) of melatonin, sedating antihistamines, CBD/THC used for sleep, valerian, ashwagandha, or other sleep-targeted supplements. * Initiation of a new dietary supplement targeted at sleep, mood, cognition, or digestion within the 30 days prior to enrollment, or planning to start such a supplement during the study. * Heavy drinkers, defined as more than 8 alcoholic drinks per week for women and more than 15 alcoholic drinks per week for men. * Currently taking thyroid medication. * Currently testing, or plan to in the next 12 weeks, a product for another research study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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