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The Effects of Energy Imbalance on Food Intake Behaviors

The Effects of Energy Imbalance on Food Intake Behaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03112161
Enrollment
76
Registered
2017-04-13
Start date
2005-06-14
Completion date
2015-10-01
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHERUnderfeeding Feeding Period
OTHEREucaloric Feeding Period
OTHEROverfeeding Feeding Period

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in neuronal response to food vs. nonfood objects in fasted vs. fed statesDay 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

MeasureTime frameDescription
Change in food cravingsAt 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 leptin levelsAt 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 levelsAt 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 ratingsAt 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 neuronal response to hedonic vs. basic food imagesDay 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 weightBaseline 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 PYY levelsAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026