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Completed

NCT Number: NCT03112161

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Eucaloric Feeding Period

Other

Overfeeding Feeding Period

Other

Underfeeding Feeding Period

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Apr 13, 2017
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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