The Chocolate Study

May 23, 2018 updated by: Oregon Research Institute

An fMRI Test of the Dynamic Vulnerability Model of Obesity: Risk Factor Plasticity

The purpose of this study is to test the dynamic vulnerability model of obesity using brain imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obese vs lean humans show greater gustatory/oral somatosensory and reward region responsivity to palatable food images/cues and this predicts future weight gain (Yokum et al., 2011; Stice et al., 2008, 2010b; Stoeckel et al., 2008), in line with reward surfeit and incentive sensitization models of obesity (Berridge, 2009; Davis et al., 2004). Yet, obese vs lean humans have fewer dopamine (DA) receptors in striatal reward regions, show reduced striatal response to palatable food intake, and low striatal response predicts future weight gain in those at genetic risk for reduced DA signaling (Felsted et al., 2010; Stice et al., 2008; Wang et al., 2001; Volkow et al., 2008), in line with the reward deficit model of obesity (Wang et al., 2002b). One explanation for the mixed findings is that some of these findings reflect initial risk factors and others result from overeating. Firing of DA neurons in reward regions shifts from food intake to cues that predict food intake after conditioning (Kiyatkin et al., 1994; Schultz et al., 1993) and overeating leads to reduced D2 receptor density, D2 sensitivity, and reward sensitivity in rats (Alsio et al., 2010; Kelley et al., 2003; Johnson & Kenny, 2010) and striatal response to food in humans (Stice et al., 2010a), implying that overeating leads to increased incentive sensitization and down-regulation of reward regions. Further, reduced inhibitory region response to food images/cues predicts future overeating and weight gain (Cornier et al., 2010). Data imply that youth at risk for obesity initially show greater responsivity of regions that encode the reward value of food cues, coupled with greater responsivity of gustatory/oral somatosensory regions that encode the sugar and fat content of foods, and with reduced inhibitory region responsivity, which lead to overeating/weight gain that produces blunted striatal DA signaling, increased responsivity of reward valuation regions to food cues, and reduced inhibitory activation in response to food stimuli, increasing risk for further overeating/weight gain. We propose to conduct a rigorous test of this dynamic-vulnerability model using a novel repeated measures fMRI design in which teens complete scans annually over 4 years. Aim 1: test whether elevated gustatory/oral somatosensory and reward region responsivity and reduced inhibitory region responsivity to palatable food images, cues, and intake of food varying in sugar/fat content, and behavioral inhibitory control deficits/immediate reward bias predict initial increases in % body fat in 130 lean teens. Aim 2: use growth curve models to test whether initial increases in % body fat and energy dense food intake predict future decreases in striatal response to palatable food receipt, increases in reward circuitry response to palatable food images/cues, decreased inhibitory region response to food images/cues, and increased behavioral inhibitory control deficits/immediate reward bias. Aim 3: test whether decreased striatal response to palatable food, increased reward region response to food images/cues, reduced inhibitory region response to food images/cues, behavioral inhibitory control deficits/immediate reward bias predict further escalation in % body fat.

Study Type

Observational

Enrollment (Actual)

131

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
    • Oregon
      • Portland, Oregon, United States, 97232
        • Oregon Research Institute

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

Ages Eligible for Study

14 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

130 lean adolescents between 14-16 years old with BMIs between the 25th and 75th percentile at baseline

Description

Inclusion Criteria:

  • between 14-16 years old
  • BMI between 25th and 75th percentile

Exclusion Criteria:

  • contraindicators of functional magnetic resonance imaging (fMRI)

    1. metal implants
    2. braces
    3. pregnancy
  • symptoms of major psychiatric disorders (substance use disorders, conduct disorder, attention deficit hyperactive disorder, major depression, bipolar disorder, panic disorder, agoraphobia, generalized anxiety disorder)
  • binge eating
  • use of pyschoactive drugs
  • serious medical conditions (diabetes, brain injury)
  • smoking
  • dietary allergy to dairy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lean adolescents
Other: Functional Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increases in BMI
Time Frame: 1, 2, 3, and 4 years
Whether increases in BMI are predicted by: elevated reward region responsivity and reduced inhibitory region responsivity to palatable food varying in sugar/fat content (measured during fMRI scan)
1, 2, 3, and 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
striatal response to palatable food receipt; reward response and inhibitory response to palatable food cues, and inhibitory control deficits/immediate reward bias
Time Frame: 1, 2, 3, and 4 years
whether increases in BMI and food intake predict: decreased striatal response to palatable food receipt, increased reward response and decreased inhibitory response to palatable food cues, and increased inhibitory control deficits/immediate reward bias (as measured during fMRI scan assessment).
1, 2, 3, and 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
increases in BMI
Time Frame: 4 years
whether future increases in BMI (measured at 3 year follow-up) is predicted by: decreased striatal response to palatable food, increased reward response to food cues, reduced inhibitory response to food cues, and behavioral inhibitory control deficits/immediate reward bias (as measured in fMRI scan assessment)
4 years

Collaborators and Investigators

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

Sponsor

Oregon Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 092468
  • R01DK092468 (U.S. NIH Grant/Contract)

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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