Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

13. mai 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

17

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Shanghai CTI Medical Laboratory

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: NatureU Sweet Dream
Participants received NatureU Sweet Dream with warm water 1 hour before sleep during the test-product session.
Kosttilskudd: 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.
Kosttilskudd: Commercially Available Melatonin Product
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.
Kosttilskudd: 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.
Kosttilskudd: Commercially Available Melatonin Product
The comparator was a commercially available melatonin product taken during the comparator session.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in Deep Sleep Percentage Between NatureU Sweet Dream and Comparator Product
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety and Tolerability During Test-Food Sessions
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

OmniSolutions Laboratory Holdings Limited

Etterforskere

  • Studieleder: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. april 2024

Primær fullføring (Faktiske)

17. april 2024

Studiet fullført (Faktiske)

17. april 2024

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SECCR/2024-56-01 (Annen identifikator: Shanghai Ethics Committee for Clinical Research)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to privacy protection and ethical considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Søvnforstyrrelser

Kliniske studier på NatureU Sweet Dream

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Indonesia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere