Gac Fruit Oil Supplementation for Visual Health and Sleep Quality
Study on Visual Health Promotion and Carotenoids From Momordica Cochinchinensis
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2023
CompletedFirst Submitted
Initial submission to the registry
May 28, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedJune 3, 2026
May 1, 2026
11 months
May 28, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Sleep Quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index before and after 30 days of gac fruit oil supplementation.
Baseline and 30 days
Secondary Outcomes (9)
Change in Depressive Symptoms
Baseline and 30 days
Change in Macular Pigment Level
Baseline and 30 days
Change in Ocular Surface Disease Symptoms
Baseline and 30 days
Change in Tear Film Parameters
Baseline and 30 days
Change in Contrast Sensitivity
Baseline and 30 days
- +4 more secondary outcomes
Study Arms (1)
Gac Fruit Oil Supplementation
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults aged 40 to 65 years.
- Participants with sleep disturbance.
- Participants who were willing to participate in the study and provide written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yuanpei University of Medical Technology
Hsinchu, 30015, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chao-Kai Chang
Yuanpei University of Medical Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2026
First Posted
June 3, 2026
Study Start
September 1, 2022
Primary Completion
July 16, 2023
Study Completion
July 16, 2023
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.