Energy Cost for Holding a MedGem® Indirect Calorimeter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Resting Metabolic Rate (RMR)
研究概览
简要总结
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.
详细描述
Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:
- RMR with MedGem® Indirect Calorimeter
- RMR without MedGem® Indirect Calorimeter
Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).
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
- None
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
- •Age between 18-65 y
- •BMI 25-40 kg/m2
排除标准
- •Diabetes mellitus
- •Current smoker
- •Presently on a weight loss regimen
- •Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
- •Claustrophobia
- •Pregnant or breastfeeding
- •Congestive heart failure
- •Chronic kidney disease
- •Pacemaker or other metal implants
研究组 & 干预措施
Not holding, then holding the MedGem®
Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.
干预措施: Not holding, then holding the MedGem® (Device)
Not holding, then holding the MedGem®
Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.
干预措施: Holding, then not holding the MedGem® (Device)
Holding, then not holding the MedGem®
Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.
干预措施: Not holding, then holding the MedGem® (Device)
Holding, then not holding the MedGem®
Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.
干预措施: Holding, then not holding the MedGem® (Device)
结局指标
主要结局
Resting Metabolic Rate (RMR)
时间窗: 3 hours
Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
次要结局
未报告次要终点
研究者
Eric Ravussin
Associate Executive Director for Clinical Science
Pennington Biomedical Research Center