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A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes
Sponsor: OmniSolutions Laboratory Holdings Limited
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
Conditions
Interventions
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.
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