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

2026년 6월 25일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • San Francisco, California, 미국, 94109
        • Alethios, Inc.
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
건강 보조 식품: 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).
위약 비교기: Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).
다른: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nutraland USA, Inc.

협력자

Alethios, Inc.

수사관

  • 수석 연구원: Dr. Bill Clark, PhD, Natprologix, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 6월 25일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 25일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NLZR-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다