The Effects of Energy Imbalance on Food Intake Behaviors

April 7, 2017 updated by: University of Colorado, Denver
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Eucaloric
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.
Other: Eucaloric Feeding Period
EXPERIMENTAL: Overfed
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).
Other: Overfeeding Feeding Period
EXPERIMENTAL: Underfed
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).
Other: Underfeeding Feeding Period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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 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.
Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)
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
Baseline and every 6 months for up to 5 years after study participation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2005

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05-0067
  • R01DK072174 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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