A Randomized, Controlled, Cross-over Trial Investigating the Impact of a High-protein Diet on Energy Metabolism in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
研究概览
简要总结
The aim of this study is to investigate the impact of a high-protein diet (achieved with the use of a nutritional supplement, Almased®) versus a diet of a typical North American macronutrient distribution on energy metabolism, metabolic blood markers and appetite sensations.
This study will be a randomized, controlled, cross-over trial of an acute nutritional intervention. A total of 20 participants will be randomly assigned (1:1) to one of the following groups:
- Control group (CON).
- High protein diet group (HP).
The diets given to participants in both groups will be eucaloric.
While receiving the diets in the whole body calorimetry unit for 32 hours, participants' overall changes in energy metabolism, metabolic blood markers, and appetite sensations will be assessed.
详细描述
This study will be a randomized, controlled, cross-over trial of an acute nutritional intervention. The participants will be randomly assigned (1:1) to one of the following groups:
- Control group (CON). Those assigned to the CON will receive a diet composed of 55% of carbohydrate, 15% of protein, and 30% of lipid (similar to the North American dietary pattern [3]).
- High protein diet group (HP). Those assigned to the HP will receive a diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®).
The diets given to participants in both groups will be eucaloric.
The following metabolic changes will be assessed between the diets:
- Energy metabolism (energy expenditure and substrate oxidation);
- Metabolic blood markers [glucose, insulin, lipid panel, peptide tyrosine-tyrosine (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, leptin, free glycerol, and free fatty acids];
- Appetite sensations (hunger, satiety, fullness, and prospective food consumption).
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoker;
- •Aged 18 to 34.9 years;
- •BMI between 18.5 and 24.9 kg/m² (preferably between 20 and 24.9 kg/m2);
排除标准
- •Have previously been diagnosed with any chronic disease;
- •Are taking any medications which may alter energy metabolism or body composition (exception: if taking antidepressants in a stable dose for > two months);
- •Are lactose, gluten and/or soy allergic/intolerant;
- •Follow a vegetarian, vegan or restrictive dietary pattern;
- •Have used nutritional supplements in the past two months (except micronutrients);
- •Are performing or have performed over an hour per day of leisure time physical activity or more than seven hours per week of strenuous activity in the past three months;
- •Have had a nuclear medicine scan or injection of an X-ray dye in the past week;
- •Have had a barium test/exam in the last two weeks;
- •Suffer from claustrophobia.
结局指标
主要结局
Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
时间窗: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
To measure the differences in fat balance during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
次要结局
- Difference in 24-hour energy expenditure assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.(During a 32-hour period while receiving a HP total diet replacement or a CON diet.)
研究者
Carla Prado
Assistant Professor / CAIP Chair in Nutrition, Food and Health, CIHR New Investigator
University of Alberta