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

Официальное название

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

Обзор

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.

Подробное описание

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 changes in the Pittsburgh Sleep Quality Index (PSQI) from baseline to end of study, the protocol investigates continuous objective sleep architecture by assessing daily wearable ring data. This secondary analysis utilizes the Oura Ring platform to evaluate advanced parameters, including sleep efficiency, total sleep time, deep sleep and REM sleep duration, sleep latency, and resting heart rate and heart rate variability dynamics.

Вмешательства

• Пищевая добавка Lotus Seed & Rice Germ Extract
  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).
• Другое Placebo
  An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).

Первичные конечные точки

• Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6 [Срок оценки: Baseline (T0) to Week 6 (T42)]

Вторичные конечные точки (10)

• Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6 [Срок оценки: Baseline Week (7-days prior to T0) and final week (T42)]
• Change from Baseline Objective Total Sleep Time at Week 6 [Срок оценки: Baseline Week (7-days prior to T0) and final week (T42)]
• Change from Baseline Objective Sleep Latency at Day 42 [Срок оценки: Baseline Week (7-days prior to T0) to Final Week (T42)]
• Change from Baseline Objective REM Sleep Duration at Day 42 [Срок оценки: Baseline week (7-days prior to T0) and final week (T42)]
• Change from Baseline Objective Deep Sleep Duration at Day [Срок оценки: Baseline week (7-days prior to T0) and final week (T42)]
• Change from Baseline Nocturnal Resting Heart Rate at Day 42 [Срок оценки: Baseline week (7-days prior to T0) and final week (T42)]
• Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 42 [Срок оценки: Baseline Week (7-days prior to T0) to Final Week (T42)]
• Change from Baseline in Insomnia Severity Index (ISI) Total Score at Week 6 [Срок оценки: Baseline (T0) to Week 6 (T42)]
• Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6 [Срок оценки: Baseline (T0) to Week 6 (T42)]
• Change from Baseline in Health-Related Quality of Life (SF-36 Domain Scores) at Week 6 [Срок оценки: Baseline (T0) to Week 6 (T42)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Alethios, Inc. — San Francisco

Идентификаторы

NCT: NCT07678359 · NLZR-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗