Clinical trial NCT03112161: The Effects of Energy Imbalance on Food Intake Behaviors
Official title: The Effects of Energy Imbalance on Food Intake Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-04-13
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Change in neuronal response to food vs. nonfood objects in fasted vs. fed states
timeFrame: Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)
Secondary outcomes:
measure: Change in appetite ratings
timeFrame: 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.
measure: Change in food cravings
timeFrame: At baseline and both before and after a meal on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding).
measure: Change in leptin levels
timeFrame: 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.
measure: Change in ghrelin levels
timeFrame: 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.
measure: Change in PYY levels
timeFrame: 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.
measure: Change in neuronal response to hedonic vs. basic food images
timeFrame: Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)
measure: Change in body weight
timeFrame: Baseline and every 6 months for up to 5 years after study participation.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Tregellas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Marc-Andre Cornier, MD
role: PRINCIPAL_INVESTIGATOR
References: