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OpenTrials
Completed

NCT Number: NCT02047721

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.

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Behavioral

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 outcomes

  1. fMRI Response to Visual Food Cues

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Diabetes Association

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2014
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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