A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes (NUSD)
13 maj 2026 uppdaterad av: OmniSolutions Laboratory Holdings Limited
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina
- Shanghai CTI Medical Laboratory
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: NatureU Sweet Dream
Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session.
|
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.
The comparator was a commercially available melatonin product taken during the comparator session.
|
|
Aktiv komparator: Commercially Available Melatonin Product
Participants received a commercially available melatonin product during the comparator session.
|
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.
The comparator was a commercially available melatonin product taken during the comparator session.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product
Tidsram: 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.
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in Deep Sleep Percentage Between NatureU Sweet Dream and Comparator Product
Tidsram: 24 hours
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety and Tolerability During Test-Food Sessions
Tidsram: 72 hours
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 april 2024
Primärt slutförande (Faktisk)
17 april 2024
Avslutad studie (Faktisk)
17 april 2024
Studieregistreringsdatum
Först inskickad
6 maj 2026
Först inskickad som uppfyllde QC-kriterierna
13 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SECCR/2024-56-01 (Annan identifierare: Shanghai Ethics Committee for Clinical Research)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to privacy protection and ethical considerations.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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