NCT02303080已完成不适用
Whey Protein Micelles and Thermogenesis In Overweight Subjects
Société des Produits Nestlé (SPN)0 个研究点目标入组 17 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- thermic effect of food
研究概览
简要总结
The main objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels.
It will be a randomized crossover double-blind design conducted in 20 subjects.
详细描述
Primary objective and outcome:
The primary objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels (WPM).
Secondary objectives and outcomes:
Explore the mechanism of action of WPM on thermogenesis including:
Protein turnover in response to the dose and the source of protein (WPM versus casein) Insulinemic and glycemic response to the dose and source of protein (WPM versus casein)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her subjects over 20 year informed consent.
排除标准
- •Chronic or acute diseases affecting protein metabolism (diabetes, renal insufficiency, CVD, liver disease), dyslipidemia History of varicose or venous stases Recent major surgery (3 months) History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc...) Malabsorption disorders History of cancer within the past year Significant weight loss during the last 3 months Food allergies, especially cow milk protein. Pregnancy or lactation Special diets especially vegetarian, high protein (≥ 1.6 g/kg) or weight loss program Abnormal Food Frequency Questionnaire Aversion to vanilla or chocolate aromas Smoking Moderate to intense physical activity > 2 hours/week Hematocrit <40 for males and < 36 for females Blood donation within 3 months of study start and 3 months after study end Regular consumption of medication and supplements i.e. any treatment affecting thermogenesis or nutrient metabolism in general such as corticosteroids, insulin, androgens, antibiotics and nutritional supplements (multivitamins, protein shakes).
- •Have a high alcohol consumption (more than 1 drink/day) Consumption of illicit drugs Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
结局指标
主要结局
thermic effect of food
时间窗: 7 hours from baseline measurements
gas exchanges through indirect calorimetry
次要结局
- Whole body protein turnover(7 hours from baseline)
研究者
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