Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 12, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedMay 31, 2017
May 1, 2017
9 months
November 12, 2013
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Metabolic Flexibility by Room Calorimetry
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).
24 hours
Secondary Outcomes (1)
Continuous Glucose Monitoring
24 hours
Study Arms (4)
High Intensity Exercise, High Carbohydrate Beverage
EXPERIMENTALStudy 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.
High Intensity Exercise, High Fat Beverage
EXPERIMENTALStudy 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.
Low Intensity Exercise, High Carbohydrate Beverage
EXPERIMENTALStudy 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.
Low Intensity Exercise, High Fat Beverage
EXPERIMENTALStudy 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.
Interventions
While in the calorimeter, each subject will complete four bouts of exercise. Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously. Subjects then sit quietly until either the next meal or the next exercise bout.
While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max. Subjects then sit quietly until the next meal.
Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
Eligibility Criteria
You may qualify if:
- Males and Females
- Age 22 to 35 years at beginning of study
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Beltsville Human Nutrition Center
Beltsville, Maryland, 20705, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Physiologist
Study Record Dates
First Submitted
November 12, 2013
First Posted
November 19, 2013
Study Start
December 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 31, 2017
Record last verified: 2017-05