Clinical trial NCT02152501: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: obese
overweight
exercise
energy expenditure differences
relative reinforcing values (RRV)
food
physical activity
biological
neurobehavioral
behavioral
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-06-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Negative Energy Balance as assessed by changes in adipose tissue
timeFrame: End Training (weeks 10-12)
Secondary outcomes:
measure: Change in relative reinforcing value (RRV) of food
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Average daily calories consumed as assessed by dietary recall
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Pre-post intervention changes in Ghrelin plasma levels
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Pre-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levels
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Pre-post intervention changes in Ghrelin concentrations
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Pre-post intervention changes in irisin concentrations
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Pre-post intervention changes in myostatin plasma levels
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Change in relative reinforcing value (RRV) of physical activity
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
measure: Change in minutes of sedentary behavior, as assessed by activity tracker
timeFrame: Pre-intervention (week 0) and End Training (weeks 10-12)
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Reserach Center
state: North Dakota
Study officials:
affiliation: USDA GFHNRC
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References: