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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| Ministry of Education, Singapore | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze-dried table grape powder | Experimental | The intervention group will consume 46 g/day of a 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried table grape powder | Dietary Supplement | Consumption of 46g/day freeze-dried table grape powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in flow mediate dilation | Flow mediate dilation (%) | week 0 and week 16 |
| Change in endothelial function | Endothelial functions are determined by the function of endothelial progenitor cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Eun Kim | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore | Singapore | 117546 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17101537 | Background | 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. | |
| 37605542 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Placebo of the table grape powder | Dietary Supplement | Consumption of 46g/day placebo version of the freeze-dried table grape powder |
|
| week 0 and week 16 |
| Change in the concentration if Endothelin-1 in plasma | Endothelin-1 concentration | week 0 and week 16 |
| Change in the concentration if Nitric Oxide in plasma | Nitric Oxide concentration | week 0 and week 16 |
| Change in body weight | Body weight (kg) measured using body scale | 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 | 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 | Every four weeks (week 0, week 4, week 8, week 12, week 16) |
| change in waist circumference | Waist circumference (cm) measured using measuring tape | Every four weeks (week 0, week 4, week 8, week 12, week 16) |
| Change in the concentration of malondialdehyde in plasma | Malondialdehyde concentration | 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 | Every eight weeks (week 0, week 8, week 16) |
| Change in blood glucose concentration | Blood glucose concentration (mmol/l) | Every eight weeks (week 0, week 8, week 16) |
| Change in total cholesterol | Total cholesterol (mmol/l) | Every eight weeks (week 0, week 8, week 16) |
| Change in high-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mmol/l) | Every eight weeks (week 0, week 8, week 16) |
| Change in low-density lipoprotein cholesterol | Low-density lipoprotein cholesterol (mmol/l) | Every eight weeks (week 0, week 8, week 16) |
| Change in total triglyceride | Total triglyceride (mmol/l) | Every eight weeks (week 0, week 8, week 16) |