A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes

NCT07600528 | Completed

• 1 other identifier: SECCR/2024-56-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disturbance; Sleep Quality

Keywords

NatureU Sweet Dream; sleep; deep sleep duration; deep sleep percentage; GABA; Lactium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 hours

Other Outcomes (1)

• Safety and Tolerability During Test-Food Sessions

  72 hours

Study Arms (2)

NatureU Sweet Dream

EXPERIMENTAL

Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session.

Dietary Supplement: NatureU Sweet Dream; Dietary Supplement: Commercially Available Melatonin Product

Commercially Available Melatonin Product

ACTIVE COMPARATOR

Participants received a commercially available melatonin product during the comparator session.

Dietary Supplement: NatureU Sweet Dream; Dietary Supplement: Commercially Available Melatonin Product

Interventions

NatureU Sweet Dream DIETARY_SUPPLEMENT

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; NatureU Sweet Dream

Commercially Available Melatonin Product DIETARY_SUPPLEMENT

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

Commercially Available Melatonin Product; NatureU Sweet Dream

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OmniSolutions Laboratory Holdings Limited: lead

Study Sites (1)

Shanghai CTI Medical Laboratory

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Luke Law, Dr

  OmniSolutions Laboratory Holdings Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The study was open-label with no masking.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants completed two independent test-food sessions: one comparator session with a commercially available melatonin product and one test-product session with NatureU Sweet Dream.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 20, 2026
• Study Start: April 15, 2024
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)