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Gac Fruit Oil Supplementation for Visual Health and Sleep Quality

28. maj 2026 opdateret af: Yuanpei University of Medical Technology

Study on Visual Health Promotion and Carotenoids From Momordica Cochinchinensis

This study evaluated the effects of gac fruit oil supplementation on visual health, sleep quality, depressive symptoms, cognitive function, and brain imaging parameters in adults with sleep disturbance. Participants aged 40 to 65 years were recruited and received gac fruit oil capsules for 30 days. The supplementation protocol consisted of two capsules in the morning and two capsules in the evening each day. Assessments were performed before and after the intervention, including macular pigment measurement, ocular surface disease evaluation, tear film analysis, contrast sensitivity testing, accommodative microfluctuation analysis, optical coherence tomography, the Pittsburgh Sleep Quality Index, a depression scale, the Mini-Mental State Examination, and brain magnetic resonance imaging. The study aimed to explore whether 30 days of gac fruit oil supplementation was associated with changes in visual function, sleep quality, mood-related measures, cognitive function, and brain imaging findings.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Hsinchu, Taiwan, 30015
        • Yuanpei University of Medical Technology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 40 to 65 years.
  • Participants with sleep disturbance.
  • Participants who were willing to participate in the study and provide written informed consent.

Exclusion Criteria:

  • History of ocular surgery.
  • Cataract.
  • Glaucoma.
  • Current supplementation intended to increase macular pigment level.
  • Pregnancy.
  • Severe illness.
  • Use of medications that may affect or stimulate sleep.
  • Use of medications that promote sleep.
  • Unable to undergo magnetic resonance imaging, including but not limited to individuals with a pacemaker, artificial heart valve, metal aneurysm clip, metallic tracheostomy tube, possible metallic fragments in the orbit, cochlear implant, implanted electrodes, neurostimulator, implanted drug infusion device, hemostatic clips, vascular stents, claustrophobia, previous brain surgery, or history of traumatic brain injury with implanted metal materials.
  • Participants who experienced discomfort during the study or wished to withdraw could discontinue participation at any time without providing a reason.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gac Fruit Oil Supplementation
Participants received gac fruit oil capsules for 30 days. The supplementation protocol consisted of two capsules in the morning and two capsules in the evening each day.
Kosttilskud: Gac Fruit Oil Capsules
Participants took gac fruit oil capsules orally for 30 days. The supplementation protocol consisted of two capsules in the morning and two capsules in the evening each day, for a total of four capsules per day.
Andre navne:
  • Momordica cochinchinensis Oil Capsules

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Sleep Quality
Tidsramme: Baseline and 30 days
Sleep quality was assessed using the Pittsburgh Sleep Quality Index before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Depressive Symptoms
Tidsramme: Baseline and 30 days
Depressive symptoms were assessed using a depression scale before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Macular Pigment Level
Tidsramme: Baseline and 30 days
Macular pigment level was assessed using a macular pigment screener before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Ocular Surface Disease Symptoms
Tidsramme: Baseline and 30 days
Ocular surface disease symptoms were assessed using the Ocular Surface Disease Index before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Tear Film Parameters
Tidsramme: Baseline and 30 days
Tear film parameters were assessed using a non-contact ocular surface analyzer before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Contrast Sensitivity
Tidsramme: Baseline and 30 days
Contrast sensitivity was assessed using the CVS-1000 contrast sensitivity test before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Accommodative Microfluctuation
Tidsramme: Baseline and 30 days
Accommodative microfluctuation was assessed using an accommodative microfluctuation analyzer before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Retinal Structure
Tidsramme: Baseline and 30 days
Retinal structure was assessed using optical coherence tomography before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Cognitive Function
Tidsramme: Baseline and 30 days
Cognitive function was assessed using the Mini-Mental State Examination before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Change in Brain Magnetic Resonance Imaging Parameters
Tidsramme: Baseline and 30 days
Brain magnetic resonance imaging parameters were assessed before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yuanpei University of Medical Technology

Efterforskere

  • Ledende efterforsker: Chao-Kai Chang, Yuanpei University of Medical Technology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2022

Primær færdiggørelse (Faktiske)

16. juli 2023

Studieafslutning (Faktiske)

16. juli 2023

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YPU-IRB-1110708

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study data include health-related questionnaire responses, ophthalmic examination data, and brain magnetic resonance imaging data. Data were collected under the informed consent and confidentiality procedures approved by the institutional review board.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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