Eye HealthNCT05064865
Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults
A study testing Freeze-dried table grape powder in people with Eye Health and Age-related Macular Degeneration, run by National University of Singapore at 1 site in Singapore.
Trial summary
Aging epidemics in Singapore are rapidly increasing and Age-related macular degeneration (AMD) prevalence is significantly associated with older age. This study aims to understand the effect of consuming freeze-dried table grape powder on AMD in an older population. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Health, Age-related Macular Degeneration
- What is being tested?
- Freeze-dried table grape powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Jan 2022to Oct 2024
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants, aged between 60 and 85 years old inclusive
- Able to give informed consent in English
Who cannot join
- Smokers
- Allergy to grapes
- Known eye diseases (macular degeneration, cataracts, retinopathy or glaucoma), blindness in at least one eye or have had eye surgery
- Abnormal kidney and liver function
- Taking eye medication and/or dietary supplements for the eyes for the past 3 months
- Taking supplements containing carotenoids (e.g. Vitamin A, lutein, zeaxanthin) for the past 3 months
Show all 14Show fewer
- Currently on type 2 diabetic medication.
- Currently on anti-hypertensive or cholesterol-lowering; unless this prescription has been ongoing for more than 3 years prior to study participation.
- Currently on a specialized diet (e.g. vegetarian, vegan, weight loss diet, low fat diet)
- Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
- Significant change in weight (≥ 3 kg body weight) in the past 3 months
- Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- Poor peripheral venous access based on past experiences with blood draw
- Participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Aging epidemics in Singapore are rapidly increasing and Age-related macular degeneration (AMD) prevalence is significantly associated with older age. This study aims to understand the effect of consuming freeze-dried table grape powder on AMD in an older population.
Read the detailed description
This will be carried out through a 16-week double-blind, randomized, placebo-controlled trial of parallel study design. Thirty-eight men and women (aged between 60 and 85 years old inclusive) will recruited and assigned to an intervention or placebo group. The intervention group will consume 46 g/day of a freeze-dried table grape and the control group will consume the same amount of a placebo, table grape placebo powder. Measurements of 1) macular pigment optical density (MPOD), a clinical marker for eye health, 2) carotenoids status, 3) markers of oxidative stress, 4) markers of endothelial function, 5) body size and blood pressure, and 6) dietary assessment will be assessed over the 16-week study. This study will consist of 1 screening visit and 5 study visits in 4-week intervals to the Food Science and Technology Department, Occupational Health Clinic and National University Heart Centre.
- Conditions
- Eye Health, Age-related Macular Degeneration
- Being tested
- Freeze-dried table grape powder, Placebo of the table grape powder
- Keywords
- Eye Health, Age-related Macular Degeneration, carotenoids
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried table grape powderDietary supplement
Consumption of 46g/day freeze-dried table grape powder
Placebo of the table grape powderDietary supplement
Consumption of 46g/day placebo version of the freeze-dried table grape powder
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried table grape powder | Experimental | The intervention group will consume 46 g/day of a freeze-dried table grape powder. Receives: Dietary Supplement: Freeze-dried table grape powder |
| Placebo grape powder | Placebo comparator | The control group will consume the same amount of a placebo with a similar taste to the table grape powder. Receives: Dietary Supplement: Placebo of the table grape powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macular pigment optical density
Macular pigment optical density will be measured using macular pigment scanner
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in skin carotenoid status
Skin carotenoid status (a.u) measured using NuSkin II, resonance Raman spectroscopy
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in blood carotenoid concentration
Blood carotenoid concentration to be quantified by HPLC
Measured: Every eight weeks (week 0, week 8, week 16)
Secondary outcomes (15)
Change in flow mediate dilation
Flow mediate dilation (%)
Measured: week 0 and week 16
Change in endothelial function
Endothelial functions are determined by the function of endothelial progenitor cells
Measured: week 0 and week 16
Change in the concentration if Endothelin-1 in plasma
Endothelin-1 concentration
Measured: week 0 and week 16
Change in the concentration if Nitric Oxide in plasma
Nitric Oxide concentration
Measured: week 0 and week 16
Change in body weight
Body weight (kg) measured using body scale
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) measured using sphygmomanometer
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
change in waist circumference
Waist circumference (cm) measured using measuring tape
Measured: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in the concentration of malondialdehyde in plasma
Malondialdehyde concentration
Measured: Every eight weeks (week 0, week 8, week 16)
Change in the concentration of 8-iso-prostaglandin F2α in plasma
8-iso-prostaglandin F2α concentration
Measured: Every eight weeks (week 0, week 8, week 16)
Change in blood glucose concentration
Blood glucose concentration (mmol/l)
Measured: Every eight weeks (week 0, week 8, week 16)
Change in total cholesterol
Total cholesterol (mmol/l)
Measured: Every eight weeks (week 0, week 8, week 16)
Change in high-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mmol/l)
Measured: Every eight weeks (week 0, week 8, week 16)
Change in low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (mmol/l)
Measured: Every eight weeks (week 0, week 8, week 16)
Change in total triglyceride
Total triglyceride (mmol/l)
Measured: Every eight weeks (week 0, week 8, week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start28 Jan 2022
- Primary completion31 Aug 2022
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye HealthStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Ministry of Education, Singapore
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- Jung Eun Kim, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064865
- Sponsor's protocol ID
- S15
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Electronic copies of the data with identifiable participant information will be key data will be de-identified prior to statistical analysis
Publications
Gehrs KM, Anderson DH, Johnson LV, Hageman GS. Age-related macular degeneration--emerging pathogenetic and therapeutic concepts. Ann Med. 2006;38(7):450-71. doi: 10.1080/07853890600946724.
PubMed 17101537Hu W, Zheng R, Feng Y, Tan D, Chan Chung-Tsing G, Su X, Kim JE. Impacts of regular consumption of grapes on macular pigment accumulation in Singapore older adults: a randomized controlled trial. Food Funct. 2023 Sep 19;14(18):8321-8330. doi: 10.1039/d3fo02105j.
PubMed 37605542
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults
- ClinicalTrials.gov ID
- NCT05064865
- Acronym / sponsor ID
- S15
- Conditions
- Eye Health, Age-related Macular Degeneration
- Keywords
- Eye Health, Age-related Macular Degeneration, carotenoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Ministry of Education, Singapore
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Oct 2021 (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.
Aging epidemics in Singapore are rapidly increasing and Age-related macular degeneration (AMD) prevalence is significantly associated with older age. This study aims to understand the effect of consuming freeze-dried table grape powder on AMD in an older population.
Detailed description
This will be carried out through a 16-week double-blind, randomized, placebo-controlled trial of parallel study design. Thirty-eight men and women (aged between 60 and 85 years old inclusive) will recruited and assigned to an intervention or placebo group. The intervention group will consume 46 g/day of a freeze-dried table grape and the control group will consume the same amount of a placebo, table grape placebo powder. Measurements of 1) macular pigment optical density (MPOD), a clinical marker for eye health, 2) carotenoids status, 3) markers of oxidative stress, 4) markers of endothelial function, 5) body size and blood pressure, and 6) dietary assessment will be assessed over the 16-week study. This study will consist of 1 screening visit and 5 study visits in 4-week intervals to the Food Science and Technology Department, Occupational Health Clinic and National University Heart Centre.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried table grape powder | Experimental | Dietary Supplement: Freeze-dried table grape powderThe intervention group will consume 46 g/day of a freeze-dried table grape powder. |
| Placebo grape powder | Placebo comparator | Dietary Supplement: Placebo of the table grape powderThe control group will consume the same amount of a placebo with a similar taste to the table grape powder. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female participants, aged between 60 and 85 years old inclusive
- Able to give informed consent in English
Key exclusion criteria (14 listed)
- Smokers
- Allergy to grapes
- Known eye diseases (macular degeneration, cataracts, retinopathy or glaucoma), blindness in at least one eye or have had eye surgery
- Abnormal kidney and liver function
- Taking eye medication and/or dietary supplements for the eyes for the past 3 months
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 |
|---|---|---|
| Freeze-dried table grape powderConsumption of 46g/day freeze-dried table grape powder | Dietary supplement | Freeze-dried table grape powder |
| Placebo of the table grape powderConsumption of 46g/day placebo version of the freeze-dried table grape powder | Dietary supplement | Placebo grape powder |
Primary outcome
Change in macular pigment optical density
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Macular pigment optical density will be measured using macular pigment scanner
Change in skin carotenoid status
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Skin carotenoid status (a.u) measured using NuSkin II, resonance Raman spectroscopy
Change in blood carotenoid concentration
Time frame: Every eight weeks (week 0, week 8, week 16)
Blood carotenoid concentration to be quantified by HPLC
15 secondary outcomes
Change in flow mediate dilation
Time frame: week 0 and week 16
Change in endothelial function
Time frame: week 0 and week 16
Change in the concentration if Endothelin-1 in plasma
Time frame: week 0 and week 16
Change in the concentration if Nitric Oxide in plasma
Time frame: week 0 and week 16
Change in body weight
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in BMI
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in blood pressure
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
change in waist circumference
Time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Change in the concentration of malondialdehyde in plasma
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in the concentration of 8-iso-prostaglandin F2α in plasma
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in blood glucose concentration
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in total cholesterol
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in high-density lipoprotein cholesterol
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in low-density lipoprotein cholesterol
Time frame: Every eight weeks (week 0, week 8, week 16)
Change in total triglyceride
Time frame: Every eight weeks (week 0, week 8, week 16)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 17101537Gehrs KM, Anderson DH, Johnson LV, Hageman GS. Age-related macular degeneration--emerging pathogenetic and therapeutic concepts. Ann Med. 2006;38(7):450-71. doi: 10.1080/07853890600946724.
- Derived from this study: PubMed 37605542Hu W, Zheng R, Feng Y, Tan D, Chan Chung-Tsing G, Su X, Kim JE. Impacts of regular consumption of grapes on macular pigment accumulation in Singapore older adults: a randomized controlled trial. Food Funct. 2023 Sep 19;14(18):8321-8330. doi: 10.1039/d3fo02105j.
- Individual participant dataSharing planned: No. Electronic copies of the data with identifiable participant information will be key data will be de-identified prior to statistical analysis
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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.
Jung Eun Kim principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried table grape powder in people with Eye Health and Age-related Macular Degeneration, run by National University of Singapore at 1 site in Singapore.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 macular pigment optical density (time frame: Every four weeks (week 0, week 4, week 8, week 12, week 16)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064865, which also lists 2 linked publications.
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 9 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.