NCT03863431Unknown不适用
The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Whole-body insulin sensitivity index
研究概览
简要总结
This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.
Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test [OGTT]).
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •BMI = 18.5-29.9 kg/m2
- •Male or female
- •Physically active (> 3 x 30 min moderate exercise per week)
- •Non-smoker (including the use of vaporisers and e-cigarettes)
- •Healthy (determined by the School's standard health questionnaire)
- •No cardiometabolic or inflammatory illness
排除标准
- •Outside of age-range
- •Outside BMI range
- •Inactive (< 3 x 30 min moderate exercise per week)
- •Taking medication
- •History of cardiometabolic or inflammatory illness
- •Vegetarian/ vegan (as the high-fat diet is based on animal fats)
- •Other dietary restrictions which prevent consumption of the experimental diet
- •Consumption of probiotics within last 3 months (these influence the gut microbiota)
- •Participation in another clinical trial
- •Those with known or suspected food intolerances, allergies or hypersensitivity
- •Women who are known to be pregnant or who are intending to become pregnant over the course of the study
结局指标
主要结局
Whole-body insulin sensitivity index
时间窗: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14
Assessed by oral glucose tolerance test
次要结局
- Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)(Day 0, Day 7, Day 14)
- Indirect calorimetry(Day 0, Day 7, Day 14)
- Body Mass Index(Day 0, Day 7, Day 14)
- Fasting plasma glucose concentration(Day 0, Day 7, Day 14)
- Subjective appetite ratings(Day 0, Day 7, Day 14)
- Fasting serum insulin concentration(Day 0, Day 7, Day 14)
研究者
Carl Hulston
Senior Lecturer Nutrition and Metabolism
Loughborough University
研究点 (2)
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