Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Baseline level and change in rate of oxygen consumption
研究概览
简要总结
The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.
详细描述
The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.
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
- Single (Outcomes Assessor)
盲法说明
Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index 18.5 - 39.9 kg/m2
排除标准
- •BMI < 18.5 or > 40 kg/m2
- •Presence of untreated or uncontrolled metabolic diseases
- •Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)
- •Presence of Crohn's disease, irritable bowel syndrome, or colitis
- •Previous gallbladder removal
- •Presence of cancer or other serious chronic disease
- •Implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator
- •Presence of a large amount of metal in the body such as a hip implant
- •Current use of tobacco in any form
- •Claustrophobia
- •Dietary restrictions that would interfere with consuming study meals
- •Pregnant or nursing within the last 6 months, or plan to become pregnant
结局指标
主要结局
Baseline level and change in rate of oxygen consumption
时间窗: Measured continuously from baseline up to 600 minutes post-meal
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in respiratory exchange ratio (RER)
时间窗: Measured continuously from baseline up to 600 minutes post-meal
RER is expressed as the ratio of VCO2 to VO2
Baseline level and change in rate of carbon dioxide production
时间窗: Measured continuously from baseline up to 600 minutes post-meal
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in urinary nitrogen excretion
时间窗: Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Urinary nitrogen measured via combustion and gas analysis in mg
次要结局
- Body weight(Baseline)
- Baseline level and change in satiety(Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal)
- Baseline level and change in prospective consumption(Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal)
- Baseline level and change in thermic effect of food (TEF)(Expressed from baseline up to 600 minutes post-meal)
- Body fat(Baseline)
- Lean body mass(Baseline)
- Hip circumference(Baseline)
- Baseline level and change in hunger(Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal)
- Baseline level and change in fat combustion(Expressed from baseline up to 600 minutes post-meal)
- Baseline level and change in heart rate(Expressed from baseline up to 600 minutes post-meal)
- Total body water(Baseline)
- Waist circumference(Baseline)
- Blood pressure(Baseline)
- General health and well-being(Baseline)
- Heart rate(Baseline)
- Body temperature(Baseline)
- Baseline level and change in desire to eat(Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal)
- Baseline level and change in energy expenditure(Expressed from baseline up to 600 minutes post-meal)
- Usual physical activity(Baseline)
- Baseline level and change in carbohydrate combustion(Expressed from baseline up to 600 minutes post-meal)