NCT01527604已完成不适用
Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: 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
- 16
- 试验地点
- 2
- 主要终点
- Change in biomarkers of inflammation compared with placebo
研究概览
简要总结
The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men & postmenopausal women, age 50 years and over
- •BMI 30-36 kg/m2
- •waist:hip ratio > 0.8 for women, > 0.9 for men
排除标准
- •Cigarette smoking and/or nicotine replacement use
- •Individuals taking estrogen
- •Use of cholesterol-lowering medications
- •Use of blood pressure-lowering medications
- •Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter [OTC])
- •Cardiovascular (heart) disease
- •Gastrointestinal disease
- •Kidney disease
- •Endocrine disease: including diabetes, untreated thyroid disease
- •Rheumatoid arthritis
- •Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- •Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg
- •Regular use of oral steroids
- •Regular daily intake of ≥ 2 alcoholic drinks
- •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 inflammation compared with placebo
时间窗: Baseline and 8 weeks
Primary outcome measures will include selected biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein).
次要结局
- Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo(Baseline and 8 weeks)
研究者
研究点 (2)
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