Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults

Sponsor
National University, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05064865
Collaborator
National University Hospital, Singapore (Other), Ministry of Education, Singapore (Other)
38
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2
20.1
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Freeze-dried table grape powder
  • Dietary Supplement: Placebo of the table grape powder
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults
Actual Study Start Date :
Jan 28, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Freeze-dried table grape powder

The intervention group will consume 46 g/day of a freeze-dried table grape powder.

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

Placebo Comparator: Placebo grape powder

The control group will consume the same amount of a placebo with a similar taste to the table grape powder.

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

Outcome Measures

Primary Outcome Measures

  1. Change in macular pigment optical density [Every four weeks (week 0, week 4, week 8, week 12, week 16)]

    Macular pigment optical density will be measured using macular pigment scanner

  2. Change in skin carotenoid status [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

  3. Change in blood carotenoid concentration [Every eight weeks (week 0, week 8, week 16)]

    Blood carotenoid concentration to be quantified by HPLC

Secondary Outcome Measures

  1. Change in flow mediate dilation [week 0 and week 16]

    Flow mediate dilation (%)

  2. Change in endothelial function [week 0 and week 16]

    Endothelial functions are determined by the function of endothelial progenitor cells

  3. Change in the concentration if Endothelin-1 in plasma [week 0 and week 16]

    Endothelin-1 concentration

  4. Change in the concentration if Nitric Oxide in plasma [week 0 and week 16]

    Nitric Oxide concentration

  5. Change in body weight [Every four weeks (week 0, week 4, week 8, week 12, week 16)]

    Body weight (kg) measured using body scale

  6. Change in BMI [Every four weeks (week 0, week 4, week 8, week 12, week 16)]

    Weight and height will be combined to report BMI in kg/m^2

  7. Change in blood pressure [Every four weeks (week 0, week 4, week 8, week 12, week 16)]

    Systolic and diastolic blood pressure (mmHg) measured using sphygmomanometer

  8. change in waist circumference [Every four weeks (week 0, week 4, week 8, week 12, week 16)]

    Waist circumference (cm) measured using measuring tape

  9. Change in the concentration of malondialdehyde in plasma [Every eight weeks (week 0, week 8, week 16)]

    Malondialdehyde concentration

  10. Change in the concentration of 8-iso-prostaglandin F2α in plasma [Every eight weeks (week 0, week 8, week 16)]

    8-iso-prostaglandin F2α concentration

  11. Change in blood glucose concentration [Every eight weeks (week 0, week 8, week 16)]

    Blood glucose concentration (mmol/l)

  12. Change in total cholesterol [Every eight weeks (week 0, week 8, week 16)]

    Total cholesterol (mmol/l)

  13. Change in high-density lipoprotein cholesterol [Every eight weeks (week 0, week 8, week 16)]

    High-density lipoprotein cholesterol (mmol/l)

  14. Change in low-density lipoprotein cholesterol [Every eight weeks (week 0, week 8, week 16)]

    Low-density lipoprotein cholesterol (mmol/l)

  15. Change in total triglyceride [Every eight weeks (week 0, week 8, week 16)]

    Total triglyceride (mmol/l)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University of Singapore Singapore Singapore 117546

Sponsors and Collaborators

  • National University, Singapore
  • National University Hospital, Singapore
  • Ministry of Education, Singapore

Investigators

  • Principal Investigator: Jung Eun Kim, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jung Eun Kim, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT05064865
Other Study ID Numbers:
  • S15
First Posted:
Oct 1, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jung Eun Kim, Assistant Professor, National University, Singapore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022