A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes

OmniSolutions Laboratory Holdings Limited17 enrolled

Overview

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.

The study evaluated the effect of NatureU Sweet Dream, an oral functional food product containing GABA and Lactium, on sleep outcomes. During the screening period, study staff explained the study procedures, product intake method, and wearable monitoring method, and participants signed informed consent before enrollment. Participants were issued a Huawei Band 8 wearable device and the study product. Participants maintained normal diet and routines, avoided alcohol, and used the wearable device for sleep monitoring. In each independent test-food session, participants avoided excessive exercise 2 hours before sleep, took the assigned product with warm water 1 hour before sleep, turned off light sources before sleep, and exported sleep monitoring data the next morning from the Huawei Health application. Study enrollment started on April 15, 2024. Primary completion and last follow-up occurred on April 17, 2024. This exploratory study had no blinding and was intended to generate preliminary within-participant evidence for sleep-related outcomes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions. * Adult participant with mild to moderate sleep disturbance. * Able and willing to use the wearable sleep monitoring device according to study instructions. * Able to maintain normal diet and routine habits during the study. * Able to avoid alcohol during the study period. * Able to avoid excessive exercise 2 hours before sleep during test nights. * Able to take the assigned product with warm water 1 hour before sleep during test nights. * Willing to complete the full study procedures and provide sleep monitoring data. Exclusion Criteria: * Known allergy or hypersensitivity to the study product, comparator product, or any related ingredients. * Severe sleep disorder or other condition judged by the investigator to make participation inappropriate. * Acute or chronic illness that could affect sleep assessment or participant safety. * Use of medications, supplements, or procedures that could affect sleep outcomes during the study period. * Alcohol intake or other behavior likely to interfere with sleep testing. * Inability to use the wearable monitoring device or mobile application as required. * Serious protocol deviation or inability to tolerate the test food. * Any factor that could seriously affect study results. * Any other reason judged by the investigator to require withdrawal or exclusion.

Outcomes

Primary Outcomes

Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product

Deep sleep duration in minutes was measured using the Huawei Band 8 wearable device and exported from the Huawei Health application after each test-food session. The primary endpoint was the difference in deep sleep duration after NatureU Sweet Dream compared with the commercially available melatonin product.

Time frame: 24 hours

Secondary Outcomes

Difference in Deep Sleep Percentage Between NatureU Sweet Dream and Comparator Product

Deep sleep percentage was measured using the Huawei Band 8 wearable device and exported from the Huawei Health application after each test-food session. The secondary endpoint was the difference in deep sleep percentage after NatureU Sweet Dream compared with the commercially available melatonin product.