Completed

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

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What is being tested

High Intensity Exercise

+ High Carbohydrate Beverage

+ High Fat Beverage

Other
Who is being recruted

From 22 to 35 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUSDA Beltsville Human Nutrition Research Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleMetabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
Principal SponsorUSDA Beltsville Human Nutrition Research Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

USDA Beltsville Human Nutrition Center

Beltsville, United StatesOpen USDA Beltsville Human Nutrition Center in Google Maps
CompletedOne Study Center