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The Effects of Energy Imbalance on Food Intake Behaviors

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ClinicalTrials.gov Identifier: NCT03112161
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Other: Eucaloric Feeding Period Other: Overfeeding Feeding Period Other: Underfeeding Feeding Period Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Energy Imbalance on Food Intake Behaviors
Actual Study Start Date : June 14, 2005
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in neuronal response to food vs. nonfood objects in fasted vs. fed states [ Time Frame: 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 :
  1. Change in appetite ratings [ Time Frame: 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.

  2. Change in food cravings [ Time Frame: 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.

  3. Change in leptin levels [ Time Frame: 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.

  4. Change in ghrelin levels [ Time Frame: 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.

  5. Change in PYY levels [ Time Frame: 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.

  6. Change in neuronal response to hedonic vs. basic food images [ Time Frame: 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.

  7. Change in body weight [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112161


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jason Tregellas, PhD University of Colorado, Denver
Principal Investigator: Marc-Andre Cornier, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03112161    
Other Study ID Numbers: 05-0067
R01DK072174 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No