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

2026年6月25日 更新者：Nutraland USA, Inc.

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • San Francisco、California、美国、94109
        • Alethios, Inc.
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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 ≥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 Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：ZenRest™ Group
50 mg proprietary lotus seed and rice germ extract blend capsule, taken once daily, 30-60 minutes before bedtime for 6 weeks (42 days).
膳食补充剂：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).
安慰剂比较：Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).
其他：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
大体时间：Baseline (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.
Baseline (T0) to Week 6 (T42)

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6
大体时间：Baseline Week (7-days prior to T0) and final week (T42)
Average weekly percentage of time spent in bed classified as sleep, calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline Week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Total Sleep Time at Week 6
大体时间：Baseline Week (7-days prior to T0) and final week (T42)
Total accumulated sleep duration in minutes per night, calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline Week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Sleep Latency at Day 42
大体时间：Baseline Week (7-days prior to T0) to Final Week (T42)
The time taken to transition from full wakefulness to sleep in minutes, calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) to the final week (mean of days 36-42).
Baseline Week (7-days prior to T0) to Final Week (T42)
Change from Baseline Objective REM Sleep Duration at Day 42
大体时间：Baseline week (7-days prior to T0) and final week (T42)
Total duration of Rapid Eye Movement (REM) sleep in minutes per night, calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Deep Sleep Duration at Day
大体时间：Baseline week (7-days prior to T0) and final week (T42)
Total duration of Deep (slow-wave) sleep in minutes per night, calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Nocturnal Resting Heart Rate at Day 42
大体时间：Baseline week (7-days prior to T0) and final week (T42)
Average overnight resting heart rate in beats per minute (bpm), calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 42
大体时间：Baseline Week (7-days prior to T0) to Final Week (T42)
Overnight Heart Rate Variability (HRV) in milliseconds (ms), calculated using nightly passive Oura Ring wearable device metrics comparing the baseline week (mean of 7 days prior to starting study product at T0) against the final week (mean of days 36-42).
Baseline Week (7-days prior to T0) to Final Week (T42)
Change from Baseline in Insomnia Severity Index (ISI) Total Score at Week 6
大体时间：Baseline (T0) to Week 6 (T42)
A 7-item questionnaire assessing the severity and impact of insomnia symptoms. Total scores range from 0 to 28, where higher scores indicate greater insomnia severity. A decrease from baseline represents an improvement.
Baseline (T0) to Week 6 (T42)
Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
大体时间：Baseline (T0) to Week 6 (T42)
An 8-item questionnaire measuring a participant's general level of daytime sleepiness across daily activities. Total scores range from 0 to 24, where higher scores indicate greater excessive daytime sleepiness. A decrease from baseline represents an improvement.
Baseline (T0) to Week 6 (T42)
Change from Baseline in Health-Related Quality of Life (SF-36 Domain Scores) at Week 6
大体时间：Baseline (T0) to Week 6 (T42)
A 36-item tool measuring health status across 8 distinct domains (including vitality and mental health). Each domain is scored from 0 to 100, where higher scores represent a better quality of life and health status. An increase from baseline indicates an improvement.
Baseline (T0) to Week 6 (T42)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nutraland USA, Inc.

合作者

Alethios, Inc.

调查人员

  • 首席研究员：Dr. Bill Clark, PhD、Natprologix, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NLZR-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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