Sleep DisturbanceNCT07623070
Gac Fruit Oil Supplementation for Visual Health and Sleep Quality
A study testing Gac Fruit Oil Capsules in people with Sleep Disturbance and Visual Health, run by Yuanpei University of Medical Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Sleep Disturbance, Visual Health
- What is being tested?
- Gac Fruit Oil Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 16 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 65 years.
- Participants with sleep disturbance.
- Participants who were willing to participate in the study and provide written informed consent.
Who cannot join
- History of ocular surgery.
- Cataract.
- Glaucoma.
- Current supplementation intended to increase macular pigment level.
- Pregnancy.
- Severe illness.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep Disturbance, Visual Health
- Being tested
- Gac Fruit Oil Capsules
- Keywords
- Gac fruit oil, Momordica cochinchinensis, Sleep quality, Visual health, Depressive symptoms
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gac Fruit Oil CapsulesDietary supplement
Also called Momordica cochinchinensis Oil Capsules
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Gac Fruit Oil Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Secondary outcomes (9)
Change in Depressive Symptoms
Depressive symptoms were assessed using a depression scale before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Macular Pigment Level
Macular pigment level was assessed using a macular pigment screener before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Ocular Surface Disease Symptoms
Ocular surface disease symptoms were assessed using the Ocular Surface Disease Index before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Tear Film Parameters
Tear film parameters were assessed using a non-contact ocular surface analyzer before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Contrast Sensitivity
Contrast sensitivity was assessed using the CVS-1000 contrast sensitivity test before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Accommodative Microfluctuation
Accommodative microfluctuation was assessed using an accommodative microfluctuation analyzer before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Retinal Structure
Retinal structure was assessed using optical coherence tomography before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Cognitive Function
Cognitive function was assessed using the Mini-Mental State Examination before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Change in Brain Magnetic Resonance Imaging Parameters
Brain magnetic resonance imaging parameters were assessed before and after 30 days of gac fruit oil supplementation.
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Sep 2022
- Primary completion16 Jul 2023
- Study completion16 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same intervention: gac fruit oil capsules for 30 days. Outcomes were assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanpei University of Medical Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-Kai Chang, Principal investigator, Yuanpei University of Medical Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623070
- Sponsor's protocol ID
- YPU-IRB-1110708
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Visual Health Promotion and Carotenoids From Momordica Cochinchinensis
- ClinicalTrials.gov ID
- NCT07623070
- Acronym / sponsor ID
- YPU-IRB-1110708
- Conditions
- Sleep Disturbance, Visual Health
- Keywords
- Gac fruit oil, Momordica cochinchinensis, Sleep quality, Visual health, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuanpei University of Medical TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 16 Jul 2023 (actual)
- Study completion
- 16 Jul 2023 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same intervention: gac fruit oil capsules for 30 days. Outcomes were assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Gac Fruit Oil Supplementation | Experimental | Dietary Supplement: Gac Fruit Oil CapsulesParticipants 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40 to 65 years.
- Participants with sleep disturbance.
- Participants who were willing to participate in the study and provide written informed consent.
Key exclusion criteria (10 listed)
- History of ocular surgery.
- Cataract.
- Glaucoma.
- Current supplementation intended to increase macular pigment level.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gac Fruit Oil CapsulesAlso: Momordica cochinchinensis Oil CapsulesParticipants 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. | Dietary supplement | Gac Fruit Oil Supplementation |
Primary outcome
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.
9 secondary outcomes
Change in Depressive Symptoms
Time frame: Baseline and 30 days
Change in Macular Pigment Level
Time frame: Baseline and 30 days
Change in Ocular Surface Disease Symptoms
Time frame: Baseline and 30 days
Change in Tear Film Parameters
Time frame: Baseline and 30 days
Change in Contrast Sensitivity
Time frame: Baseline and 30 days
Change in Accommodative Microfluctuation
Time frame: Baseline and 30 days
Change in Retinal Structure
Time frame: Baseline and 30 days
Change in Cognitive Function
Time frame: Baseline and 30 days
Change in Brain Magnetic Resonance Imaging Parameters
Time frame: Baseline and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Kai Chang principal investigator
Yuanpei University of Medical Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gac Fruit Oil Capsules in people with Sleep Disturbance and Visual Health, run by Yuanpei University of Medical Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality (time frame: Baseline and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.