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| Name | Class |
|---|---|
| Alethios, Inc. | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZenRest™ Group | Experimental | 50 mg proprietary lotus seed and rice germ extract blend capsule, taken once daily, 30-60 minutes before bedtime for 6 weeks (42 days). |
|
| Placebo | Placebo Comparator | An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotus Seed & Rice Germ Extract | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bill Clark, Ph.D. | Contact | 727-365-3420 | drbill@natprologix.com | |
| Alethios, Inc. | Contact | 650-206-8006 | support@alethios.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Bill Clark, PhD | Natprologix, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios, Inc. | San Francisco | California | 94109 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Placebo | Other | An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days). |
|
| Change from Baseline Objective Total Sleep Time at Week 6 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| D001523 |
| Mental Disorders |