Can a lotus seed extract help menopausal women sleep through the night?
NCT ID NCT07678359
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether a daily capsule containing lotus seed and rice germ extract, called ZenRest™, can improve sleep quality in menopausal women aged 40 to 65 who have mild-to-moderate sleep problems. Participants take either the supplement or a placebo for six weeks, and sleep is measured using questionnaires and a wearable Oura Ring. The goal is to see if this natural blend offers a safe way to ease sleep troubles linked to menopause.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lotus seed and rice germ extract blend (ZenRest™)
- What this could lead to
- If it works, this could offer a natural, non-hormonal option to help menopausal women sleep better.
- What could go wrong
- This is a small, early pilot study. The supplement may not improve sleep more than a placebo, and individual results may vary.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 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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40 to 65 years
- Sex
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Female participants only
- 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: * Female, aged 40-65 years at time of enrollment * Confirmed menopausal status: (a) natural menopause (≥12 consecutive months of amenorrhea without other clinical cause), or (b) surgical menopause (bilateral oophorectomy with documented date of procedure) * Positive onboarding sleep screener: rates sleep quality as "Fairly Bad" or "Very Bad" AND reports sleep difficulty at least once per week in the prior month * PSQI global score \>5 at T0 baseline assessment (formal eligibility gate) * Owns and actively uses an Oura Ring Generation 4 at time of enrollment * Demonstrates ≥80% Oura Ring wear compliance in the 30 days prior to enrollment, confirmed via Alethios platform sync at onboarding * Willing to wear Oura Ring Generation 4 continuously for 42 nights throughout the study period * Willing to maintain stable diet, sleep habits, medications, and supplement use throughout the 42-day study period * No planned major disruptions to sleep schedule, shift work, or travel across ≥3 time zones during the study period * Access to a smartphone or computer to complete eConsent and digital questionnaires * Able to provide informed consent via the Alethios eConsent platform Exclusion Criteria: * Current use of prescription sleep medications (benzodiazepines, non-benzodiazepine hypnotics, doxepin, suvorexant) within 30 days of enrollment * Current use of melatonin supplements at doses \>1 mg/day within 14 days of enrollment * Diagnosis of a clinically significant sleep disorder requiring treatment (obstructive sleep apnea unless adequately treated and stable, restless legs syndrome, narcolepsy) * Diagnosis of a major psychiatric disorder currently requiring pharmacological treatment * Current use of hormone replacement therapy initiated within 90 days of enrollment, or any planned changes to HRT during the study (stable long-term HRT is acceptable) * Regular use of GABAergic, serotonergic, or sedating supplements (valerian, passionflower, ashwagandha, kava) within 14 days of enrollment * Shift work or schedule regularly requiring sleep between 06:00 and 22:00 * Planned travel across 3 or more time zones during the 42-day study period * Known allergy to lotus, rice, or related botanicals * Active cardiovascular, hepatic, renal, or neurological condition that in the PI's judgment would affect sleep or participant safety * Participation in another interventional study within 30 days of enrollment * In the opinion of the PI, any condition compromising participant safety or data integrity
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Alethios, Inc.
San Francisco, California, 94109, United States
Contact Email: •••••@•••••
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