NCT01303562已完成不适用
Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Levels of phytochemicals and their in vivo metabolites in blood
研究概览
简要总结
The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and postmenopausal women
- •BMI 27-35.9 kg/m2
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 or laxatives (including fiber supplements)
- •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
- •Infrequent or excessive number of regular bowel movements
- •Illicit drug use
- •Vegetarians
- •No fish oil supplements (including cod liver oil) for one month prior to study admission
- •No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
结局指标
主要结局
Levels of phytochemicals and their in vivo metabolites in blood
时间窗: 24 hours
Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin
次要结局
未报告次要终点
研究者
研究点 (2)
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