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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047721
• Other study ID #: 13-3252
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 19, 2019

Study information

• Verified date: October 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Univeristy of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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