A Randomized, Double-Blind, Placebo-Controlled, 6-Week Pilot Study to Evaluate the Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women
Nutraland USA, Inc.
Summary
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.
Description
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…
Eligibility
- Age range
- 40–65 years
- Sex
- Female
- Healthy volunteers