- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06349304
Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults
April 4, 2024 updated by: Jung Eun Kim, National University of Singapore
Impact of Regular Consumption of Grape on Eye Health and Regulation of Advanced Glycation End-products in Singapore Older Adults
The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults.
The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The study will be a 16-week, double-blind, randomized, placebo-controlled trial using a parallel study design.
46 adults (aged 60 - 85) will be recruited and randomly assigned to the intervention or placebo group to investigate whether regular consumption of freeze-dried table grape powder (46g/d) can improve eye health parameters, blood/skin AGE and glycemic status, and reduce inflammation and oxidative stress.
This study will consist of 1 screening visit and 5 study visits with 4-week intervals.
Study Type
Interventional
Enrollment (Estimated)
46
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 Contact
- Name: Marcus Ting
- Phone Number: 97851245
- Email: marcusting@u.nus.edu
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
Yes
Description
Inclusion Criteria:
- Male and female participants, aged between 60 and 85 years old inclusive
- English-literate and able to give informed consent in English
Exclusion Criteria:
- Smokers
- Allergy to grapes or food dyes/additives, or had serious food allergies in the past
- Known eye diseases (macular degeneration, cataracts, retinopathy or glaucoma), blindness in at least one eye or have had eye surgery
- Unable to view bright lights or flashing lights
- Has Type 1 or 2 diabetes, uremia, cardiovascular disease, abnormal kidney and liver function
- Taking eye medication and/or dietary supplements for the eyes for the past 3 month
- Taking supplements containing carotenoids (e.g. Vitamin A, lutein, zeaxanthin) for past 3 months
- Currently on a specialised 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
- Currently on anti-hypertensive, cholesterol-lowering or psychoactive drugs
- Scored ≤ 7 on the abbreviated mental test
- Poor peripheral venous access based on past experiences with blood draw
- Participating in another clinical study
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Freeze-dried table grape powder
Subjects in this group will be given pouches, each containing 46 g of freeze-dried table grape powder, with an instruction sheet on how to prepare the powder into a drink for consumption.They will consume one pouch a day.
|
Consumption of grape powder as part of daily diet
|
Placebo Comparator: Placebo table grape powder
Subjects in this group will be given pouches, each containing 46 g of placebo grape powder, with an instruction sheet on how to prepare the powder into a drink for consumption.They will consume one pouch a day.
|
Consumption of placebo grape powder as part of daily diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular pigment optical density
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
A measurement of macular pigment of the eye using a heterochromatic flicker photometry device.
The measurements are in arbitrary units.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Visual acuity
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Participants will read out letters on a ETDRS LogMAR chart at a fixed distance where letters becomes smaller as it goes down the chart.
Tests results will be recorded in number of letters read, where the more letters the better the outcome.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Photostress recovery time
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
An ophthalmoscope will be used to shine a light into the participants eye for 10 seconds, and participants will be required to read letters off a chart the moment their vision returns to normal.
The faster the recovery time, the better the outcome.
Units will be in seconds
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Visual function questionnaire 25
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
A questionnaire to for participants to self-evaluate their perception of their current eye health based on general vision, ocular pain, near activities, distance activities, vision specific functions, driving, color vision and peripheral vision.
The best possible score is 100 and worst possible score is 0.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Skin advanced glycation end products levels
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Measurement of skin advanced glycation end products level using a skin autofluorescence device, where participants wlll be instructed to place their forearm over the device and a light will be shone and a reading can be captured by detecting fluorescence.
The results will be presented as arbitrary units.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Dietary advanced glycation end products level
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Participants will be instructed to record down 3-day food records, from Thursday to Saturday, before each clinical visit.
This will be used to estimate their advanced glycation end products intake from food by referring to existing nutrient databases.
Units will be based on a common advanced glycation end product measured, carboxymethyllysine (CML), thus the unit will be mg CML/ kg food
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Blood advanced glycation end products levels
Time Frame: Week 0, Week 8 and Week 16
|
Participants will have their blood drawn by medical professionals at the Occupational Health Clinic.
The blood will be processed and stored.
Measurements will be done using ultra-performance liquid chromatography coupled with mass spectrometry techniques to determine the levels of advanced glycation end products.
Units will be in μg/mL.
|
Week 0, Week 8 and Week 16
|
Contrast sensitivity
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Participants will read out letters on a ETDRS LogMAR chart at a fixed distance, where the letters differs in lightness to test participants' sensitivity to contrast.
Tests results will be recorded in number of letters read, where the more letters the better the outcome.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of tumour necrosis factor-α
Time Frame: Week 0, Week 8, Week 16
|
The blood obtained from the participants will be processed for storage.
Tumor necrosis factor-α results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.
|
Week 0, Week 8, Week 16
|
Concentration of interleukin-6
Time Frame: Week 0, Week 8, Week 16
|
The blood obtained from the participants will be processed for storage.
Interleukin-6 results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.
|
Week 0, Week 8, Week 16
|
Concentration of high-sensitivity C-reactive protein
Time Frame: Week 0, Week 8, Week 16
|
The blood obtained from the participants will be processed for storage.
Analyses of inflammation markers include tumor necrosis factor-α, interleukin-6.
high sensitivity C-reactive protein.
Tumor necrosis factor-α and interleukin-6 results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.
High-sensitivity C-reactive protein results will be obtained and presented in mg/L by commercial lab testing.
|
Week 0, Week 8, Week 16
|
Concentration of fasting blood glucose
Time Frame: Week 0, Week 8, Week 16
|
Fasting blood glucose will be measured using commercial lab testing using participants' blood, units will be in mmol/L.
|
Week 0, Week 8, Week 16
|
Concentration of malondialdehyde
Time Frame: Week 0, Week 8, Week 16
|
The blood obtained from the participants will be processed for storage.
Analyses of malondialdehyde using commercially available enzyme-linked immunosorbent assay kits.
Units for malondialdehyde will be in ng/L according to assay kit instructions.
|
Week 0, Week 8, Week 16
|
Concentration of 8-isoprostaglandin-F2α
Time Frame: Week 0, Week 8, Week 16
|
The blood obtained from the participants will be processed for storage.
Analyses of 8-isoprostaglandin-F2α using commercially available enzyme-linked immunosorbent assay kits.
Units for 8-isoprostaglandin-F2α will be in µmol/L according to assay kit instructions.
|
Week 0, Week 8, Week 16
|
Skin carotenoid status
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16;
|
Measured using a commercially available device that measured carotenoids using Raman spectroscopy.
Results are in arbitrary units.
|
Week 0, Week 4, Week 8, Week 12, Week 16;
|
Concentration of insulin
Time Frame: Week 0, Week 8, Week 16
|
Fasting blood insulin will be measured using commercial lab testing using participants' blood, units in μU/L.
|
Week 0, Week 8, Week 16
|
Percentage of glycated hemoglobin
Time Frame: Week 0, Week 8, Week 16
|
Glycated hemoglobin will be measured using commercial lab testing from participant's blood, units in percent.
|
Week 0, Week 8, Week 16
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of height
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Height will be measured using height-weight scale and units will be in cm.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Measurement of blood pressure
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
A blood pressure monitoring device available commercially will be used be to measure their systolic nad diastolic blood pressure.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Measurement of weight
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Weight will be measured using height-weight scale and units will be in kg.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Measurement of waist circumference
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16
|
Waist circumference will be measured using a measuring tape by a trained personnel, units in cm.
|
Week 0, Week 4, Week 8, Week 12, Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jung Eun Kim, Ph.D., R.D., National University of Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
May 1, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
March 14, 2024
First Submitted That Met QC Criteria
April 4, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- S25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Electronic copies of the data with identifiable participant information will be kept on NUS OneDrive with access limited only Dr Kim Jung Eun and her research staff.
All data will be de-identified prior to statistical analyses.
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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