NCT07623070

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Gac fruit oilMomordica cochinchinensisSleep qualityVisual healthDepressive symptoms

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

EXPERIMENTAL

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.

Dietary Supplement: Gac Fruit Oil Capsules

Interventions

Gac Fruit Oil CapsulesDIETARY_SUPPLEMENT

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.

Also known as: Momordica cochinchinensis Oil Capsules
Gac Fruit Oil Supplementation

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomniasBehavioral SymptomsBehavior

Study Officials

  • Chao-Kai Chang

    Yuanpei University of Medical Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All participants received the same intervention: gac fruit oil capsules for 30 days. Outcomes were assessed before and after the intervention.
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.

Locations