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Exercise and Weight Control

Primary Purpose

Overweight, Obese

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Energy Expenditure 300 kcal/day

Exercise Energy Expenditure 600 kcal/day

About this trial

This is an interventional other trial for Overweight focused on measuring obese, overweight, exercise, energy expenditure differences, relative reinforcing values (RRV), food, physical activity, biological, neurobehavioral, behavioral

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18 to 40 years old
BMI of 25.0 - 35 kg/m2
willing to consent to study conditions
not taking medications that affects energy expenditure or eating
not using tobacco or nicotine products
no food allergies or limitations to eating certain food that would prohibit them from eating the study foods
not be dieting to lose weight
no major health problems
cannot have known cardiovascular, pulmonary or metabolic disease
cannot be regularly exercising in an aerobic manner more than twice per week
must have a liking of at least 5 out of 10 for 75% of the study foods

Exclusion Criteria:

< 18 or > 40 years old
BMI < 25 or >35 kg/m2
currently pregnant or trying to become pregnant, or lactating
currently using tobacco or nicotine
taking medication that affects energy expenditure or eating
food allergies to foods used in the study
regularly exercising in an aerobic manner more than twice per week
major health problems

Sites / Locations

USDA Grand Forks Human Nutrition Reserach Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exercise Energy Expenditure 300 kcal/day

Exercise Energy Expenditure 600 kcal/day

Arm Description

Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day.

Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day.

Outcomes

Primary Outcome Measures

Negative Energy Balance as assessed by changes in adipose tissue

Whether participants were able to maintain a negative energy balance will be assessed by pre-post changes in stored adipose tissue, as assessed by a dual-energy x-ray absorptiometry scan (DEXA).

Secondary Outcome Measures

Change in relative reinforcing value (RRV) of food

RRV of food will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to food or an alternative sedentary activity.

Average daily calories consumed as assessed by dietary recall

On two weekdays and one weekend day, participants will fill out the Automated Self-Administered 24-Hour Dietary Recall (ASA24) to estimate dietary intake (total energy, grams carbohydrates, fat, protein, alcohol).

Pre-post intervention changes in Ghrelin plasma levels

Participants will provide a fasting blood sample collected in ethylenediaminetetraacetic acid (EDTA)-coated and serum tubes. Changes in acylated Ghrelin will be measured via enzyme-linked immunosorbent assay (ELISA).

Pre-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levels

Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in GLP-1 concentrations will be measured via ELISA.

Pre-post intervention changes in Ghrelin concentrations

Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in Ghrelin concentrations will be measured via ELISA.

Pre-post intervention changes in irisin concentrations

Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in irisin concentrations will be measured via ELISA.

Pre-post intervention changes in myostatin plasma levels

Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in myostatin levels will be measured via ELISA.

Change in relative reinforcing value (RRV) of physical activity

RRV of physical activity will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to physical activity or a sedentary alternative.

Change in minutes of sedentary behavior, as assessed by activity tracker

Minutes of sedentary behavior (non-exercise activity) will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.

Full Information

NCT ID

NCT02152501

First Posted

May 22, 2014

Last Updated

July 18, 2019

Sponsor

USDA Grand Forks Human Nutrition Research Center

1. Study Identification

Unique Protocol Identification Number

NCT02152501

Brief Title

Exercise and Weight Control

Official Title

Exercise and Weight Control: A Search for Biological and Neurobehavioral Compensatory Mechanisms That Defend Against Exercise-Induced Negative Energy Balance

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

USDA Grand Forks Human Nutrition Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to research the effects of exercise on calories eaten and expended. The investigator expects to find out whether subjects change their eating and activity behaviors when starting an exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obese

Keywords

obese, overweight, exercise, energy expenditure differences, relative reinforcing values (RRV), food, physical activity, biological, neurobehavioral, behavioral

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Energy Expenditure 300 kcal/day

Arm Type

Experimental

Arm Description

Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day.

Arm Title

Exercise Energy Expenditure 600 kcal/day

Arm Type

Experimental

Arm Description

Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day.

Intervention Type

Other

Intervention Name(s)

Exercise Energy Expenditure 300 kcal/day

Intervention Type

Other

Intervention Name(s)

Exercise Energy Expenditure 600 kcal/day

Primary Outcome Measure Information:

Title

Negative Energy Balance as assessed by changes in adipose tissue

Description

Whether participants were able to maintain a negative energy balance will be assessed by pre-post changes in stored adipose tissue, as assessed by a dual-energy x-ray absorptiometry scan (DEXA).

Time Frame

End Training (weeks 10-12)

Secondary Outcome Measure Information:

Title

Change in relative reinforcing value (RRV) of food

Description

RRV of food will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to food or an alternative sedentary activity.

Time Frame