Gac Fruit Oil Supplementation for Visual Health and Sleep Quality

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

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:
  • Momordica cochinchinensis Oil Capsules

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

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.

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