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Completed

NCT Number: NCT07623070

Gac Fruit Oil Supplementation for Visual Health and Sleep Quality

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.

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Key information

Conditions

Sleep Disturbance Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Visual Health

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuanpei University of Medical Technology

Hsinchu, 30015, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gac Fruit Oil Capsules

Dietary 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.

Other names: Momordica cochinchinensis Oil Capsules

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Yuanpei University of Medical Technology

Other

Registry information

Official study title

Study on Visual Health Promotion and Carotenoids From Momordica Cochinchinensis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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