Exercise and Weight Control

Study Overview
=================
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.

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

Conditions
-----------------
Overweight, Obese

Intervention / Treatment
-----------------
* Other: Exercise Energy Expenditure 300 kcal/day
* Other: Exercise Energy Expenditure 600 kcal/day


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Energy Expenditure 300 kcal/day<br>Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day. | Other: Exercise Energy Expenditure 300 kcal/day<br> <br> |
| Experimental: Exercise Energy Expenditure 600 kcal/day<br>Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day. | Other: Exercise Energy Expenditure 600 kcal/day<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | End Training (weeks 10-12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-intervention (week 0) and End Training (weeks 10-12) | 
| 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-intervention (week 0) and End Training (weeks 10-12) | 
| 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-intervention (week 0) and End Training (weeks 10-12) | 
| 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-intervention (week 0) and End Training (weeks 10-12) | 
| 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-intervention (week 0) and End Training (weeks 10-12) | 
| 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-intervention (week 0) and End Training (weeks 10-12) | 
| 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. | Pre-intervention (week 0) and End Training (weeks 10-12) | 
| 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. | Pre-intervention (week 0) and End Training (weeks 10-12) | 
| 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. | Pre-intervention (week 0) and End Training (weeks 10-12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food, obese, energy expenditure differences, relative reinforcing values (RRV), physical activity, biological, neurobehavioral, behavioral, overweight, exercise