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

NCT05064865 | Unknown

• 1 other identifier: S15
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Health; Age-related Macular Degeneration

Keywords

Eye Health; Age-related Macular Degeneration; carotenoids

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• Change in blood carotenoid concentration

  Blood carotenoid concentration to be quantified by HPLC

  Every eight weeks (week 0, week 8, week 16)

Secondary Outcomes (15)

• Change in flow mediate dilation

  week 0 and week 16

• Change in endothelial function

  week 0 and week 16

• Change in the concentration if Endothelin-1 in plasma

  week 0 and week 16

• Change in the concentration if Nitric Oxide in plasma

  week 0 and week 16

• Change in body weight

  Every four weeks (week 0, week 4, week 8, week 12, week 16)

Study Arms (2)

Freeze-dried table grape powder

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo of the table grape powder

Interventions

Freeze-dried table grape powder DIETARY_SUPPLEMENT

Consumption of 46g/day freeze-dried table grape powder

Freeze-dried table grape powder

Placebo of the table grape powder DIETARY_SUPPLEMENT

Consumption of 46g/day placebo version of the freeze-dried table grape powder

Placebo grape powder

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants, aged between 60 and 85 years old inclusive
• Able to give informed consent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator
• Ministry of Education, Singapore: collaborator

Study Sites (1)

National University of Singapore

Singapore, 117546, Singapore

Location

Related Publications (2)

• 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.

  PMID: 17101537 BACKGROUND

• Hu 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.

  PMID: 37605542 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jung Eun Kim

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 1, 2021
• Study Start: January 28, 2022
• Primary Completion: August 31, 2022
• Study Completion: October 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)