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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Diet
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Univeristy of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Physical Intervention

Nutritional Intervention

Arm Description

A supervised exercise program

A supervised diet program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2014
Last Updated
October 20, 2020
Sponsor
University of Colorado, Denver
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT02047721
Brief Title
The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals
Official Title
The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Intervention
Arm Type
Experimental
Arm Description
A supervised exercise program
Arm Title
Nutritional Intervention
Arm Type
Experimental
Arm Description
A supervised diet program
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week.
Primary Outcome Measure Information:
Title
fMRI Response to Visual Food Cues
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Legget, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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