Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percent change of oxidant stress and lipid oxidation
研究概览
简要总结
This is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.
详细描述
This research study will evaluate how pomegranate juice (or a placebo juice) affects the body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers, which are indicators of health, will be measured throughout the study. They are present in blood and urine. The placebo is a juice that is not made from pomegranates, but resembles pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of general health. The investigators want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to speak and read English
- •Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication
- •Have an HbA1C level ≤9.0% at Screening
- •Have an hsCRP level ≥ 1.0 at Screening
- •35 - 70 years old (inclusive)
- •Non-smokers
- •Willing to maintain his/her normal activity and eating patterns for the duration of the study
- •Willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)
排除标准
- •Allergy to pomegranates
- •Currently using insulin
- •Currently taking steroidal drugs
- •HIV positive or AIDS
- •Chronic infectious disease
- •Recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
- •Cancer treated within the past two years
- •Participation in a therapeutic research study within 30 days of baseline
- •Women who are pregnant, lactating, or planning to become pregnant during the study period
结局指标
主要结局
Percent change of oxidant stress and lipid oxidation
时间窗: baseline, week 6, week 12
次要结局
- HbA1c(baseline, week 6, week 12)
- High Sensitivity C-reactive protein HsCRP(baseline, week 6, week 12)