Sleep QualityNCT07678359
Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women
A study testing Lotus Seed & Rice Germ Extract in people with Sleep Quality and Menopause, run by Nutraland USA, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Menopause
- What is being tested?
- Lotus Seed & Rice Germ Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alethios, Inc.
San Francisco, California, 94109
Zeenia Framroze, BA MPhil, 650-206-8006, support@alethios.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Sleep Quality, Menopause
- Being tested
- Lotus Seed & Rice Germ Extract, Placebo
- Keywords
- ZenRest, Lotus Seed Extract, Rice Germ Extract, Spermidine, Neferine, Menopause, Sleep Quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotus Seed & Rice Germ ExtractDietary 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).
PlaceboOther
An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Lotus Seed & Rice Germ Extract |
| Placebo | Placebo comparator | An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) to Week 6 (T42)
Secondary outcomes (10)
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).
Measured: Baseline Week (7-days prior to T0) and final week (T42)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0) to Week 6 (T42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraland USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr. Bill Clark, PhD, Principal investigator, Natprologix, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678359
- Sponsor's protocol ID
- NLZR-001
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07678359
- Acronym / sponsor ID
- NLZR-001
- Conditions
- Sleep Quality, Menopause
- Keywords
- ZenRest, Lotus Seed Extract, Rice Germ Extract, Spermidine, Neferine, Menopause, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nutraland USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZenRest™ Group | Experimental | Dietary Supplement: Lotus Seed & Rice Germ Extract50 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 | Other: PlaceboAn identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotus Seed & Rice Germ ExtractA 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). | Dietary supplement | ZenRest™ Group |
| PlaceboAn identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days). | Other | Placebo |
Primary outcome
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6
Time frame: 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.
10 secondary outcomes
Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6
Time frame: Baseline Week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Total Sleep Time at Week 6
Time frame: Baseline Week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Sleep Latency at Day 42
Time frame: Baseline Week (7-days prior to T0) to Final Week (T42)
Change from Baseline Objective REM Sleep Duration at Day 42
Time frame: Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Objective Deep Sleep Duration at Day
Time frame: Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Nocturnal Resting Heart Rate at Day 42
Time frame: Baseline week (7-days prior to T0) and final week (T42)
Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 42
Time frame: Baseline Week (7-days prior to T0) to Final Week (T42)
Change from Baseline in Insomnia Severity Index (ISI) Total Score at Week 6
Time frame: Baseline (T0) to Week 6 (T42)
Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Time frame: Baseline (T0) to Week 6 (T42)
Change from Baseline in Health-Related Quality of Life (SF-36 Domain Scores) at Week 6
Time frame: Baseline (T0) to Week 6 (T42)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Bill Clark, PhD principal investigator
Natprologix, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotus Seed & Rice Germ Extract in people with Sleep Quality and Menopause, run by Nutraland USA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Bill Clark, Ph.D. (727-365-3420, drbill@natprologix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6 (time frame: Baseline (T0) to Week 6 (T42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.