The Effects of Energy Imbalance on Food Intake Behaviors

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Eucaloric Feeding Period; Other: Overfeeding Feeding Period; Other: Underfeeding Feeding Period

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eucaloric; Participants will consume a eucaloric diet with a macronutrient composition of 20% protein, 30% fat and 50% carbohydrate for 4 days (Eucaloric Feeding Period). The caloric value of the diet will be calculated based on lean body mass plus an activity factor to ensure energy and macronutrient balance.	Other: Eucaloric Feeding Period
EXPERIMENTAL: Overfed; Following 3 days of eucaloric feeding, participants will complete a 1-day overfeeding period (Overfeeding Feeding Period), during which their diet will have a daily energy value of 40% greater than the eucaloric diet (Eucaloric Arm), although the macronutrient composition will remain the same (20% protein, 30% fat, 50% carbohydrate).	Other: Overfeeding Feeding Period
EXPERIMENTAL: Underfed; Following 3 days of eucaloric feeding, participants will complete a 1-day underfeeding period (Underfeeding Feeding Period), during which their diet will have a daily energy value of 40% less than the eucaloric diet (Eucaloric Arm), although the macronutrient composition will remain the same (20% protein, 30% fat, 50% carbohydrate).	Other: Underfeeding Feeding Period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in neuronal response to food vs. nonfood objects in fasted vs. fed states	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.	Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in appetite ratings	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.	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 food cravings	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.	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 leptin levels	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.	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 ghrelin levels	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.	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 PYY levels	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.	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 neuronal response to hedonic vs. basic food images	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.	Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)
Change in body weight	Change in body weight from baseline for up to 5 years in obese-resistant and obese-prone individuals	Baseline and every 6 months for up to 5 years after study participation.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2005
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 05-0067; R01DK072174 (NIH)

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