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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987388
• Other study ID #: HS42
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: May 30, 2017
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2017
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• High 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.
• Low Intensity Exercise
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.
• High 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.
• High 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.

Locations

Country	Name	City	State
United States	USDA Beltsville Human Nutrition Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center	United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Continuous Glucose Monitoring	Whole-day interstitial glucose profiles will be collected during each calorimeter measurement.	24 hours