Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorNutraland USA, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lotus Seed & Rice Germ Extract
Dietary supplementA 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).
Placebo
Other interventionAn identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ZenRest™ GroupExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0) to Week 6 (T42)Secondary outcomes
1
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).
Time frame
Baseline Week (7-days prior to T0) and final week (T42)2
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).
Time frame
Baseline Week (7-days prior to T0) and final week (T42)3
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).
Time frame
Baseline Week (7-days prior to T0) to Final Week (T42)4
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).
Time frame
Baseline week (7-days prior to T0) and final week (T42)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nutraland USA, Inc.
Lead sponsor
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov
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