NCT01303562已完成不适用
Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 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
研究组 & 干预措施
Test muffin made with whole oats
Active Comparator
干预措施: Whole grain oats and barley (Other)
Placebo muffin made with no whole grains
Placebo Comparator
干预措施: Whole grain oats and barley (Other)
Test muffin made with whole barley
Active Comparator
干预措施: Whole grain oats and barley (Other)
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 (1)
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