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| ID | Type | Description | Link |
|---|---|---|---|
| SECCR/2024-56-01 | Other Identifier | Shanghai Ethics Committee for Clinical Research |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NatureU Sweet Dream | Experimental | Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session. |
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| Commercially Available Melatonin Product | Active Comparator | Participants received a commercially available melatonin product during the comparator session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Law, Dr | OmniSolutions Laboratory Holdings Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai CTI Medical Laboratory | Shanghai | Shanghai Municipality | China |
Individual participant data will not be shared due to privacy protection and ethical considerations.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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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.
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The study was open-label with no masking.
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| Commercially Available Melatonin Product | Dietary Supplement | The comparator was a commercially available melatonin product taken during the comparator session. |
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| D020920 | Dyssomnias |