Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women

Part of paid clinical trials in San Francisco, California.

Sponsor
Nutraland USA, Inc.
Study ID
NCT07678359
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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).
  • 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).

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • Placebo Comparator: Placebo
    An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).

Primary Outcome Measure

Change from Baseline in Subjective Sleep Quality (PSQI Global Score) at Week 6 [ Time Frame: Baseline (T0) to Week 6 (T42) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios, Inc.San FranciscoCalifornia94109
Zeenia Framroze, BA MPhil
[email protected]
650-206-8006

Find similar trials in San Francisco, CA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Alethios, Inc.· San Francisco, CA

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