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

25 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94109
        • Alethios, Inc.
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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).
Suplemento dietético: 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).
Comparador de Placebo: Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).
Outro: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Nutraland USA, Inc.

Colaboradores

Alethios, Inc.

Investigadores

  • Investigador principal: Dr. Bill Clark, PhD, Natprologix, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

25 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2026

Primeira postagem (Real)

1 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NLZR-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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