NCT01527617已完成不适用
The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Change in biomarkers of oxidative stress compared with placebo.
研究概览
简要总结
The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men & women, aged 30-70 years
- •BMI 27-34.9 kg/m2
- •waist:hip ratio > 0.8 for women and > 0.9 for men
排除标准
- •Cigarette smoking and/or nicotine replacement use within last 6 months
- •Individuals taking estrogen or testosterone
- •Use of cholesterol-lowering medications
- •Use of blood pressure-lowering medications
- •Regular use (> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
- •Cardiovascular (heart) disease
- •Gastrointestinal disease
- •Kidney disease
- •Endocrine disease: including diabetes, untreated thyroid disease
- •Rheumatoid arthritis
- •Immune deficiency conditions
- •Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- •Systolic blood pressure > 139 mmHg and/or diastolic blood pressure > 89 mmHg
- •Regular use of systemic steroids, oral or injectable
- •Regular daily intake of ≥ 2 alcoholic drinks
- •Infrequent (< 3/week) or excessive (> 3/d) number of regular bowel movements
- •Gain or loss of ≥ 5% of body weight in the last 6 months
- •Pregnancy
- •Strict vegetarians
- •No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
结局指标
主要结局
Change in biomarkers of oxidative stress compared with placebo.
时间窗: Baseline and 8 weeks
Change in biomarkers of inflammation compared with placebo
时间窗: Baseline and 8 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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