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COMPLETED
NCT07600528
NA

A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes

Sponsor: OmniSolutions Laboratory Holdings Limited

View on ClinicalTrials.gov

Summary

This was a single-center, open-label, exploratory self-controlled study evaluating NatureU Sweet Dream on sleep outcomes in adults with mild to moderate sleep disturbance. Seventeen participants were enrolled, 2 participants were lost to follow-up, and 15 participants provided valid effectiveness data. Participants completed two independent test-food sessions using wearable sleep monitoring. The comparator session used a commercially available melatonin product, and the test-product session used NatureU Sweet Dream. The main outcomes were deep sleep duration and deep sleep percentage measured by a wearable device and exported through the Huawei Health application. No adverse reactions were reported during the study.

Official title: A Single-Center, Open-Label, Exploratory Self-Controlled Study of NatureU Sweet Dream on Deep Sleep Duration and Deep Sleep Percentage in Adults With Sleep Disturbance

Key Details

Gender

All

Age Range

18 Years - 44 Years

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2024-04-15

Completion Date

2024-04-17

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

NatureU Sweet Dream

NatureU Sweet Dream is an oral functional food product containing GABA and Lactium. Participants took the product with warm water 1 hour before sleep during the test-product session.

DIETARY_SUPPLEMENT

Commercially Available Melatonin Product

The comparator was a commercially available melatonin product taken during the comparator session.

Locations (1)

Shanghai CTI Medical Laboratory

Shanghai, Shanghai Municipality, China