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

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: High Fat Beverage; Other: Low Intensity Exercise; Other: High Carbohydrate Beverage; Other: High Intensity Exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01987388

HS42

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 22 to 35 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria have been established to recruit a population of individuals across a wide age-range that has typical digestive process

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 4 patient groups

High Intensity Exercise, High Carbohydrate Beverage

Experimental group

Description:

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.

Treatment:

Other: High Intensity Exercise

Other: High Carbohydrate Beverage

High Intensity Exercise, High Fat Beverage

Experimental group

Description:

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.

Treatment:

Other: High Intensity Exercise

Other: High Fat Beverage

Low Intensity Exercise, High Carbohydrate Beverage

Experimental group

Description:

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.

Treatment:

Other: High Carbohydrate Beverage

Other: Low Intensity Exercise

Low Intensity Exercise, High Fat Beverage

Experimental group

Description:

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.

Treatment:

Other: High Fat Beverage

Other: Low Intensity Exercise