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The Effects of Energy Imbalance on Food Intake Behaviors

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Obesity

Treatments

Other: Overfeeding Feeding Period
Other: Eucaloric Feeding Period
Other: Underfeeding Feeding Period

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03112161
R01DK072174 (U.S. NIH Grant/Contract)
05-0067

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

25 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

76 participants in 3 patient groups

Eucaloric
Experimental group
Description:
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.
Treatment:
Other: Eucaloric Feeding Period
Overfed
Experimental group
Description:
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).
Treatment:
Other: Overfeeding Feeding Period
Underfed
Experimental group
Description:
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).
Treatment:
Other: Underfeeding Feeding Period

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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