Exercise and Weight Control

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Obese
• Intervention / Treatment: Other: Exercise Energy Expenditure 300 kcal/day; Other: Exercise Energy Expenditure 600 kcal/day

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Reserach Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Investigators: Principal Investigator: James Roemmich, PhD, USDA GFHNRC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; exercise; overweight; food; obese; behavioral; biological; neurobehavioral; energy expenditure differences; relative reinforcing values (RRV)
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: GFHNRC028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO