The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals

In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. The Investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to those who do not lose weight. These changes in neuronal activity will be associated to physiologic and behavioral measures.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Diet

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univeristy of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all ethnic groups and both genders;
• age: 21-45 yrs;
• BMI: 27-35;
• weight stable within +/- 5 percent in the last 6 months;
• sedentary (less than 1 hour of planned physical activity by self-report).

Exclusion Criteria:

• history of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism;
• unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons;
• unable to pass screening graded exercise treadmill test;
• currently smoking;
• medications affecting weight, Energy Intake (EI) or Energy Expenditure (EE) in the last 6 months;
• weight loss or weight gain of >5 percent in past 6 months;
• currently pregnant, lactating or less than 6 months post-partum;
• bariatric surgery;
• major psychiatric disorder, presence of alcohol or substance abuse, current depression by history and/or a score >21 on the he Center for Epidemiologic Studies Depression Scale (CES-D), history of eating disorders and/or a score of >20 on the EATS-26;
• contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Intervention; A supervised exercise program	Behavioral: Exercise; The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.
Experimental: Nutritional Intervention; A supervised diet program	Behavioral: Diet; A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI Response to Visual Food Cues	The neuronal response will be assessed by functional magnetic resonance imaging (fMRI) in response to visual food cues Blood oxygen dependent signal (BOLD) response in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in those who lose weight vs. those who do not lose weight will be compared.	12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Kristina Legget, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 13-3252; UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No