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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Sleep Quality, Menopause

In brief

The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints. The main questions it aims to answer are: * Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo? * Does ZenRest™ improve objective sleep metrics, specifically sleep efficiency, when monitored via an Oura Ring wearable device? * Does the extract improve secondary sleep and lifestyle factors, such as insomnia severity, daytime sleepiness, and vitality? Researchers will compare ZenRest™ to a placebo (a look-alike capsule that contains no active ingredients) to see if the botanical blend has a measurable effect on sleep quality.

Key facts

Study ID

NCT07678359

Run by

Nutraland USA, Inc.

People needed

60

Starts

2026-07-01

Expected to finish

2026-10-01

Last updated by the study team

2026-07-01

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alethios, Inc. — San Francisco, California, United States

Full record on ClinicalTrials.gov

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