The Effects of Energy Imbalance on Food Intake Behaviors

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT03112161
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study will determine whether changes in energy balance alter regional neuronal activation of brain regions associated with food intake in individuals screened to be either resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic" value elicit changes in regional neuronal activity in the fasted and fed state in "obese-resistant" and "obese-prone" men and women in varying states of energy balance.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-14
• Primary Completion: 2015-10-01
• Study Completion: 2015-10-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

In the obese-prone group:

• BMI between 20-30
• Report at least one obese first-degree relative
• Self-describe as "struggling" with weight
• Weight-stable for at least 3 months prior to study participation

In the obese-resistant group:

• BMI between 17-25
• Report no obese first-degree relatives
• Self-describe as "naturally thin" and have never been overweight
• Overall weight stability

Exclusion Criteria

• Significant medical or psychiatric disease
• History of eating disorder
• Left handed
• Unable to complete an MRI scan (e.g., metal in body, claustrophobic)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in neuronal response to food vs. nonfood objects in fasted vs. fed states	Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)	Change in neuronal response to food vs. nonfood objects in the overfed and underfed feeding periods as compared to the eucaloric period between fasted and fed states in obese-prone as compared to obese-resistant individuals.

Secondary Outcome Measures

Name	Time	Method
Change in food cravings	At baseline and both before and after a meal on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding).	Change in food cravings (questionnaire) before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.
Change in neuronal response to hedonic vs. basic food images	Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)	Change in neuronal response to hedonic vs. basic food images in the overfed and underfed feeding periods as compared to the eucaloric period between fasted and fed states in obese-prone as compared to obese-resistant individuals.
Change in body weight	Baseline and every 6 months for up to 5 years after study participation.	Change in body weight from baseline for up to 5 years in obese-resistant and obese-prone individuals
Change in leptin levels	At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.	Change in blood leptin levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.
Change in ghrelin levels	At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.	Change in blood ghrelin levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.
Change in appetite ratings	At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.	Change in appetite ratings via visual analog scale (VAS; 0-100) before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.
Change in PYY levels	At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.	Change in blood Peptide YY (PYY) levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States