Nutraland USA, Inc.
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.
ZenRest™ is a proprietary blend of Lotus Seed Extract (Nelumbo nucifera) and Rice Germ Extract (Oryza sativa). This trial evaluates the physiological effects of continuous daily intake (50 mg/day) over a 6-week period, specifically targeting menopausal women with mild-to-moderate sleep complaints. The study utilizes a fully decentralized clinical trial framework. Behavior and physiological metrics are collected remotely utilizing home-based, integrated smart ring wearable tracking methodologies to minimize participant burden. In addition to evaluating subjective sleep indices by measuring chan…
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…
A proprietary blend of Lotus Seed Extract (Nelumbo nucifera) standardized to contain Neferine \>/=2.0% and Isoquercitrin \& Hyperoside \>/=0.5%, and Rice Germ Extract (Oryza sativa) providing Polyamines \>/=0.5% calculated as spermidine. Administered as a 50 mg capsule taken orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).
An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).
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