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临床试验/NCT01987388
NCT01987388已完成不适用

Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges

USDA Beltsville Human Nutrition Research Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Metabolic Flexibility by Room Calorimetry

研究概览

简要总结

The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans. The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the current method, which is based on glucose clamp data. It is hypothesized that this new metabolic flexibility method will be a useful and noninvasive biomarker for measuring adaptation to exercise and diet challenges.

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
22 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Males and Females
  • •Age 22 to 35 years at beginning of study

排除标准

  • •Women who have given birth during the previous 12 months
  • •Pregnant women or women who plan to become pregnant or become pregnant during the study
  • •Lactating women
  • •History or presence of diabetes, kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes.
  • •History of bariatric or certain other surgeries related to weight control
  • •Smokers or other tobacco users (for at least 6 months prior to the start of the study)
  • •History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • •Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
  • •Unable or unwilling to give informed consent or communicate with study staff
  • •Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
  • •Inclusion and exclusion criteria have been established to recruit a population of individuals across a wide age-range that has typical digestive process

研究组 & 干预措施

High Intensity Exercise, High Carbohydrate Beverage

Experimental

Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.

干预措施: High Intensity Exercise (Other)

High Intensity Exercise, High Carbohydrate Beverage

Experimental

Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.

干预措施: High Carbohydrate Beverage (Other)

High Intensity Exercise, High Fat Beverage

Experimental

Study participant consumes a high fat beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.

干预措施: High Intensity Exercise (Other)

High Intensity Exercise, High Fat Beverage

Experimental

Study participant consumes a high fat beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.

干预措施: High Fat Beverage (Other)

Low Intensity Exercise, High Carbohydrate Beverage

Experimental

Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.

干预措施: Low Intensity Exercise (Other)

Low Intensity Exercise, High Carbohydrate Beverage

Experimental

Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.

干预措施: High Carbohydrate Beverage (Other)

Low Intensity Exercise, High Fat Beverage

Experimental

Study participant consumes a high fat beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.

干预措施: Low Intensity Exercise (Other)

Low Intensity Exercise, High Fat Beverage

Experimental

Study participant consumes a high fat beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.

干预措施: High Fat Beverage (Other)

结局指标

主要结局

Metabolic Flexibility by Room Calorimetry

时间窗: 24 hours

Participants will stay in a room calorimeter for 24 hours where oxygen consumed and carbon dioxide produced will be measured. Mathematical approaches will use continuous calorimetry data to generate consistent estimates of the gas exchange rates, and hence accurate "instantaneous" respiratory exchange ratios. This novel approach allows evaluating the instantaneous dynamics of respiratory quotient noninvasively and for many different conditions (e.g., exercise and various nutrient ratios).

次要结局

  • Continuous Glucose Monitoring(24 hours)

研究者

发起方
USDA Beltsville Human Nutrition Research Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

William Rumpler

Research Physiologist

USDA Beltsville Human Nutrition Research Center

研究点 (1)

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