- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07623070
Gac Fruit Oil Supplementation for Visual Health and Sleep Quality
May 28, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hsinchu, Taiwan, 30015
- Yuanpei University of Medical Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Quality
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depressive Symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chao-Kai Chang, Yuanpei University of Medical Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
July 16, 2023
Study Completion (Actual)
July 16, 2023
Study Registration Dates
First Submitted
May 28, 2026
First Submitted That Met QC Criteria
May 28, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YPU-IRB-1110708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Disturbance
-
Università degli Studi di BresciaCompletedSleep Phase Rhythm DisturbanceItaly
-
The First Affiliated Hospital of Xiamen UniversityNot yet recruitingPostoperative Sleep Disturbance
-
Our Lady's Hospice and Care ServicesSt Vincent's University Hospital, IrelandEnrolling by invitation
-
Zhuan ZhangNot yet recruitingCircadian Rhythm | Postoperative Sleep DisturbanceChina
-
Riphah International UniversityCompletedSleep Disturbance in AthletesPakistan
-
University of BergenGlamoxCompletedSleep | Sleep Deprivation | Shift-Work Related Sleep DisturbanceNorway
-
Sam Houston State UniversityThe University of Texas Health Science Center, Houston; Memorial Hermann Texas...CompletedSleep Disturbance in Hospitalized Antepartum PatientsUnited States
-
Pacific UniversityCompletedInsomnia | Shift-Work Related Sleep DisturbanceUnited States
-
Seoul National University HospitalNot yet recruiting
-
University of North Carolina, Chapel HillWinclove Probiotics B.V.; National Strength and Conditioning Association FoundationCompletedHealthy | Shift-Work Related Sleep DisturbanceUnited States
Clinical Trials on Gac Fruit Oil Capsules
-
Academia Sinica, TaiwanNational Taiwan University HospitalCompleted
-
Indiana University School of MedicineCompletedEnd-Stage Renal Disease Patients on HemodialysisUnited States
-
Academia Sinica, TaiwanNot yet recruiting
-
University of ReadingBiotechnology and Biological Sciences Research CouncilCompletedExtracellular Vesicles; Generation and FunctionUnited Kingdom
-
Zhejiang UniversitySir Run Run Shaw HospitalUnknown
-
Jingjing JiaoCompletedSleep | Cognitive Decline | Bone Mineral DensityChina
-
Burapha UniversityCompletedBody Massage Oil From Snake Fruit | Facial Mask From Snake Fruit | Jelly From Snake FruitThailand
-
Shiraz University of Medical SciencesCompletedDiabetic NeuropathiesIran, Islamic Republic of
-
University of California, San DiegoCompletedObesity | Metabolic Syndrome | Insulin ResistanceUnited States
-
Birmingham Community Healthcare NHSNSA, LLCCompleted