Back to search results

ZenRest™ for Sleep Quality in Menopausal Women

This study is looking at whether a dietary supplement called ZenRest™ Lotus Seed & Rice Germ Extract Blend can improve sleep quality in women aged 40-65 who are going through menopause and have mild to moderate sleep problems. Researchers will compare ZenRest™ to a placebo (an inactive, look-alike capsule) to see if the supplement helps with how well you sleep, as reported by you, and also with objective sleep measurements from a wearable device like an Oura Ring. The study aims to find out if ZenRest™ can make your sleep better and reduce issues like daytime sleepiness. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This interventional study plans to enroll 60 women aged 40-65. Participants will be randomly assigned to receive either ZenRest™ or a placebo, and neither they nor the researchers will know which treatment they are receiving (this is called a blinded study).
What's involved
You would take a capsule once daily, 30-60 minutes before bedtime, for 6 weeks (42 days). Your sleep quality will be measured at the beginning and end of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 6, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07678359

Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women

Not Yet Recruiting
NAAges 40–65InterventionalTreatment
Nutraland USA, Inc.
~60 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Lotus Seed & Rice Germ ExtractPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
Measured over Baseline (T0) to Week 6 (T42)

Conditions

Sleep Quality
Menopause

Explore related trials

Menopause presentSleep Complaints

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Dr. Bill Clark, PhD · PRINCIPAL_INVESTIGATOR · Natprologix, LLC

Who to contact

Dr. Bill Clark, Ph.D.
[email protected]
727-365-3420
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6Baseline (T0) to Week 6 (T42)

    Evaluation of the change in the Pittsburgh Sleep Quality Index (PSQI) global summary score. Scores range from 0 to 21, where higher scores indicate worse sleep quality and a 3-point reduction represents the minimum clinically important difference.