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
Qualifiers
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
Treatments tested in this trial
- Lotus Seed & Rice Germ Extract
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nutraland USA, Inc.
Lead sponsor
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov