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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05064865
Other study ID # S15
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 28, 2022
Est. completion date October 2024

Study information

Verified date November 2023
Source National University of Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date October 2024
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria: - Male and female participants, aged between 60 and 85 years old inclusive - Able to give informed consent in English Exclusion Criteria: - 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 - 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

Study Design


Intervention

Dietary Supplement:
Freeze-dried table grape powder
Consumption of 46g/day freeze-dried table grape powder
Placebo of the table grape powder
Consumption of 46g/day placebo version of the freeze-dried table grape powder

Locations

Country Name City State
Singapore National University of Singapore Singapore

Sponsors (3)

Lead Sponsor Collaborator
National University of Singapore Ministry of Education, Singapore, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in macular pigment optical density Macular pigment optical density will be measured using macular pigment scanner Every four weeks (week 0, week 4, week 8, week 12, week 16)
Primary Change in skin carotenoid status Skin carotenoid status (a.u) measured using NuSkin II, resonance Raman spectroscopy Every four weeks (week 0, week 4, week 8, week 12, week 16)
Primary Change in blood carotenoid concentration Blood carotenoid concentration to be quantified by HPLC Every eight weeks (week 0, week 8, week 16)
Secondary Change in flow mediate dilation Flow mediate dilation (%) week 0 and week 16
Secondary Change in endothelial function Endothelial functions are determined by the function of endothelial progenitor cells week 0 and week 16
Secondary Change in the concentration if Endothelin-1 in plasma Endothelin-1 concentration week 0 and week 16
Secondary Change in the concentration if Nitric Oxide in plasma Nitric Oxide concentration week 0 and week 16
Secondary Change in body weight Body weight (kg) measured using body scale Every four weeks (week 0, week 4, week 8, week 12, week 16)
Secondary Change in BMI Weight and height will be combined to report BMI in kg/m^2 Every four weeks (week 0, week 4, week 8, week 12, week 16)
Secondary Change in blood pressure Systolic and diastolic blood pressure (mmHg) measured using sphygmomanometer Every four weeks (week 0, week 4, week 8, week 12, week 16)
Secondary change in waist circumference Waist circumference (cm) measured using measuring tape Every four weeks (week 0, week 4, week 8, week 12, week 16)
Secondary Change in the concentration of malondialdehyde in plasma Malondialdehyde concentration Every eight weeks (week 0, week 8, week 16)
Secondary Change in the concentration of 8-iso-prostaglandin F2a in plasma 8-iso-prostaglandin F2a concentration Every eight weeks (week 0, week 8, week 16)
Secondary Change in blood glucose concentration Blood glucose concentration (mmol/l) Every eight weeks (week 0, week 8, week 16)
Secondary Change in total cholesterol Total cholesterol (mmol/l) Every eight weeks (week 0, week 8, week 16)
Secondary Change in high-density lipoprotein cholesterol High-density lipoprotein cholesterol (mmol/l) Every eight weeks (week 0, week 8, week 16)
Secondary Change in low-density lipoprotein cholesterol Low-density lipoprotein cholesterol (mmol/l) Every eight weeks (week 0, week 8, week 16)
Secondary Change in total triglyceride Total triglyceride (mmol/l) Every eight weeks (week 0, week 8, week 16)
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