Impact of Regular Consumption of Grapes on Eye Health in Singapore Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in skin carotenoid status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants, aged between 60 and 85 years old inclusive
- •Able to give informed consent in English
排除标准
- •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
结局指标
主要结局
Change in skin carotenoid status
时间窗: 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
Change in blood carotenoid concentration
时间窗: Every eight weeks (week 0, week 8, week 16)
Blood carotenoid concentration to be quantified by HPLC
Change in macular pigment optical density
时间窗: Every four weeks (week 0, week 4, week 8, week 12, week 16)
Macular pigment optical density will be measured using macular pigment scanner
次要结局
- Change in total triglyceride(Every eight weeks (week 0, week 8, week 16))
- change in waist circumference(Every four weeks (week 0, week 4, week 8, week 12, week 16))
- Change in body weight(Every four weeks (week 0, week 4, week 8, week 12, week 16))
- Change in the concentration of malondialdehyde in plasma(Every eight weeks (week 0, week 8, week 16))
- Change in the concentration of 8-iso-prostaglandin F2α in plasma(Every eight weeks (week 0, week 8, week 16))
- Change in high-density lipoprotein cholesterol(Every eight weeks (week 0, week 8, week 16))
- Change in endothelial function(week 0 and week 16)
- Change in the concentration if Nitric Oxide in plasma(week 0 and week 16)
- Change in total cholesterol(Every eight weeks (week 0, week 8, week 16))
- Change in flow mediate dilation(week 0 and week 16)
- Change in blood glucose concentration(Every eight weeks (week 0, week 8, week 16))
- Change in low-density lipoprotein cholesterol(Every eight weeks (week 0, week 8, week 16))
- Change in the concentration if Endothelin-1 in plasma(week 0 and week 16)
- Change in BMI(Every four weeks (week 0, week 4, week 8, week 12, week 16))
- Change in blood pressure(Every four weeks (week 0, week 4, week 8, week 12, week 16))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore