Sleep DisturbanceNUSDNCT07600528
A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes
A study testing NatureU Sweet Dream and Commercially Available Melatonin Product in people with Sleep Disturbance and Sleep Quality, run by OmniSolutions Laboratory Holdings Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Sleep Disturbance, Sleep Quality
- What is being tested?
- NatureU Sweet Dream and Commercially Available Melatonin Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Sleep Disturbance, Sleep Quality
- Being tested
- NatureU Sweet Dream, Commercially Available Melatonin Product
- Keywords
- NatureU Sweet Dream, sleep, deep sleep duration, deep sleep percentage, GABA, Lactium
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatureU Sweet DreamDietary 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 ProductDietary supplement
The comparator was a commercially available melatonin product taken during the comparator session.
| Study group | Role | What they receive |
|---|---|---|
| NatureU Sweet Dream | Experimental | Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session. Receives: 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. Receives: Dietary Supplement: NatureU Sweet Dream; Dietary Supplement: Commercially Available Melatonin Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 Apr 2024
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OmniSolutions Laboratory Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Law, Dr, Study director, OmniSolutions Laboratory Holdings Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600528
- Sponsor's protocol ID
- SECCR/2024-56-01
- Other IDs
- SECCR/2024-56-01
- Acronym
- NUSD
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy protection and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07600528
- Acronym / sponsor ID
- NUSD / SECCR/2024-56-01
- Conditions
- Sleep Disturbance, Sleep Quality
- Keywords
- NatureU Sweet Dream, sleep, deep sleep duration, deep sleep percentage, GABA, Lactium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OmniSolutions Laboratory Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NatureU Sweet Dream | Experimental | Dietary Supplement: NatureU Sweet Dream, Dietary Supplement: Commercially Available Melatonin ProductParticipants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session. |
| Commercially Available Melatonin Product | Active comparator | Dietary Supplement: NatureU Sweet Dream, Dietary Supplement: Commercially Available Melatonin ProductParticipants received a commercially available melatonin product during the comparator session. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatureU Sweet DreamNatureU 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, NatureU Sweet Dream |
| Commercially Available Melatonin ProductThe comparator was a commercially available melatonin product taken during the comparator session. | Dietary supplement | Commercially Available Melatonin Product, NatureU Sweet Dream |
Primary outcome
Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product
Time frame: 24 hours
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.
1 secondary outcome
Difference in Deep Sleep Percentage Between NatureU Sweet Dream and Comparator Product
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy protection and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Law, Dr study director
OmniSolutions Laboratory Holdings Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NatureU Sweet Dream and Commercially Available Melatonin Product in people with Sleep Disturbance and Sleep Quality, run by OmniSolutions Laboratory Holdings Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.