A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes (NUSD)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Sleep Quality
• Intervention / Treatment: Dietary supplement: NatureU Sweet Dream; Dietary supplement: Commercially Available Melatonin Product

Detailed Description

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
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai CTI Medical Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NatureU Sweet Dream; Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session.	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.
Active Comparator: Commercially Available Melatonin Product; Participants received a commercially available melatonin product during the comparator session.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability During Test-Food Sessions	Safety monitoring included adverse reactions reported during the study. The report stated that no adverse reactions occurred among the 15 participants with valid data.	72 hours

Collaborators and Investigators

• Sponsor: OmniSolutions Laboratory Holdings Limited
• Investigators: Study Director: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): April 17, 2024
• Study Completion (Actual): April 17, 2024

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sleep; GABA; NatureU Sweet Dream; deep sleep duration; deep sleep percentage; Lactium
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SECCR/2024-56-01 (Other Identifier: Shanghai Ethics Committee for Clinical Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy protection and ethical considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No