The Effects of Energy Imbalance on Food Intake Behaviors
2 other identifiers
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2005
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedApril 13, 2017
April 1, 2017
10.3 years
April 7, 2017
April 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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 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 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 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 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.
- +2 more secondary outcomes
Study Arms (3)
Eucaloric
EXPERIMENTALParticipants 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.
Overfed
EXPERIMENTALFollowing 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).
Underfed
EXPERIMENTALFollowing 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant medical or psychiatric disease
- History of eating disorder
- Left handed
- Unable to complete an MRI scan (e.g., metal in body, claustrophobic)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Tregellas, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Marc-Andre Cornier, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 13, 2017
Study Start
June 14, 2005
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
April 13, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share