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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01987388
Enrollment
16
Registered
2013-11-19
Start date
2012-12-31
Completion date
2013-09-30
Last updated
2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

OTHERHigh Intensity Exercise

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.

OTHERHigh Carbohydrate Beverage

Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.

OTHERHigh Fat Beverage

Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.

Sponsors

United States Army Research Institute of Environmental Medicine
CollaboratorFED
USDA Beltsville Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic Flexibility by Room Calorimetry24 hoursParticipants 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).

Secondary

MeasureTime frameDescription
Continuous Glucose Monitoring24 hoursWhole-day interstitial glucose profiles will be collected during each calorimeter measurement.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026