Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women
25 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alethios, Inc.
- Número de teléfono: 650-206-8006
- Correo electrónico: support@alethios.com
Copia de seguridad de contactos de estudio
- Nombre: Dr. Bill Clark, Ph.D.
- Número de teléfono: 727-365-3420
- Correo electrónico: drbill@natprologix.com
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94109
- Alethios, Inc.
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Contacto:
- Zeenia Framroze, BA MPhil
- Número de teléfono: 650-206-8006
- Correo electrónico: support@alethios.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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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).
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Comparador de placebos: Placebo
An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).
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An identical, matching inactive look-alike capsule containing microcrystalline cellulose.
Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
Periodo de tiempo: Baseline (T0) to Week 6 (T42)
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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.
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Baseline (T0) to Week 6 (T42)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6
Periodo de tiempo: Baseline Week (7-days prior to T0) and final week (T42)
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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).
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Baseline Week (7-days prior to T0) and final week (T42)
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Change from Baseline Objective Total Sleep Time at Week 6
Periodo de tiempo: Baseline Week (7-days prior to T0) and final week (T42)
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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).
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Baseline Week (7-days prior to T0) and final week (T42)
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Change from Baseline Objective Sleep Latency at Day 42
Periodo de tiempo: Baseline Week (7-days prior to T0) to Final Week (T42)
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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).
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Baseline Week (7-days prior to T0) to Final Week (T42)
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Change from Baseline Objective REM Sleep Duration at Day 42
Periodo de tiempo: Baseline week (7-days prior to T0) and final week (T42)
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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).
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Baseline week (7-days prior to T0) and final week (T42)
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Change from Baseline Objective Deep Sleep Duration at Day
Periodo de tiempo: Baseline week (7-days prior to T0) and final week (T42)
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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).
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Baseline week (7-days prior to T0) and final week (T42)
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Change from Baseline Nocturnal Resting Heart Rate at Day 42
Periodo de tiempo: Baseline week (7-days prior to T0) and final week (T42)
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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).
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Baseline week (7-days prior to T0) and final week (T42)
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Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 42
Periodo de tiempo: Baseline Week (7-days prior to T0) to Final Week (T42)
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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).
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Baseline Week (7-days prior to T0) to Final Week (T42)
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Change from Baseline in Insomnia Severity Index (ISI) Total Score at Week 6
Periodo de tiempo: Baseline (T0) to Week 6 (T42)
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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.
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Baseline (T0) to Week 6 (T42)
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Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Periodo de tiempo: Baseline (T0) to Week 6 (T42)
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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.
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Baseline (T0) to Week 6 (T42)
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Change from Baseline in Health-Related Quality of Life (SF-36 Domain Scores) at Week 6
Periodo de tiempo: Baseline (T0) to Week 6 (T42)
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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.
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Baseline (T0) to Week 6 (T42)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr. Bill Clark, PhD, Natprologix, LLC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NLZR-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .