Age-related Macular Degeneration Clinical Trial
Official title:
Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults
Verified date | November 2023 |
Source | National University of Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National University of Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University of Singapore | Ministry of Education, Singapore, National University Hospital, Singapore |
Singapore,
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
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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