A daily supplement duo aims to sharpen the mind and deepen sleep — a trial puts it to the test

NCT ID NCT07721506

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The official record

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  2. A doctor treating you

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