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

NCT07678359 | Not Yet Recruiting

• 1 other identifier: NLZR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Quality; Menopause

Keywords

ZenRest; Lotus Seed Extract; Rice Germ Extract; Spermidine; Neferine; Menopause; Sleep Quality

Outcome Measures

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.

  Baseline (T0) to Week 6 (T42)

Secondary Outcomes (10)

• Change from Baseline in Objective Sleep Efficiency (%) via Oura Ring at Week 6

  Baseline Week (7-days prior to T0) and final week (T42)

• Change from Baseline Objective Total Sleep Time at Week 6

  Baseline Week (7-days prior to T0) and final week (T42)

• Change from Baseline Objective Sleep Latency at Day 42

  Baseline Week (7-days prior to T0) to Final Week (T42)

• Change from Baseline Objective REM Sleep Duration at Day 42

  Baseline week (7-days prior to T0) and final week (T42)

• Change from Baseline Objective Deep Sleep Duration at Day

  Baseline week (7-days prior to T0) and final week (T42)

Study Arms (2)

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).

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).

Other: Placebo

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).

ZenRest™ Group

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).

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nutraland USA, Inc.: lead
• Alethios, Inc.: collaborator

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dr. Bill Clark, PhD

  Natprologix, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Bill Clark, Ph.D.

CONTACT

727-365-3420; drbill@natprologix.com

Alethios, Inc.

CONTACT

650-206-8006; support@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion: September 1, 2026
• Study Completion: October 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)