- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807572
Relation of Consummatory and Anticipatory Food Reward to Obesity
Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body weight on average and most patients regain this weight within a few years. Further, most obesity prevention programs do not reduce risk for future weight gain. The limited success of treatment and prevention interventions may be due to an incomplete understanding of the processes that increase risk for obesity. Recent data suggest that obese adults show abnormalities in reward from food intake and anticipated food intake relative to lean adults, but the precise nature of these abnormalities is unclear and it has not been established whether these abnormalities predate obesity onset or are a consequence. It is vital to elucidate risk factors for obesity onset to advance understanding of etiological processes and determine the content of prevention and treatment programs.
The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by virtue of having two obese parents, show abnormalities in reward from food intake (consummatory food reward) and anticipated reward from food intake (anticipatory food reward) compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities in consummatory and anticipatory food reward increase risk for weight gain and obesity onset, (3) examine moderators that may amplify the relations of consummatory and anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory food reward in those participants who show obesity onset relative to those not showing obesity onset. Each of these goals is described in more detail below.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- We will require that adolescents have age- and sex- adjusted standardized body mass index (BMI) scores between the 25th and 75th percentile at baseline for inclusion.
- Low risk youth: Lean parents will have a BMI between 18 and 25.
- High risk youth: Obese parents will have a BMI value of greater than 30.
Exclusion Criteria:
- Students who report contraindicators of fMRI (e.g., metal implants, braces, or pregnancy).
- Current major psychiatric disorders (including substance use disorders, conduct disorder, oppositional defiant disorder, ADHD, major depression, bipolar disorder, panic disorder, agoraphobia, or generalized anxiety disorder)
- Current use of analgesics and other psychoactive drugs (e.g., cocaine)
- Serious medical complications (e.g., diabetes)
- Relevant food allergies
- Current smoking
- Current weight loss dieting
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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obesity risk status
Lean adolescents at high-risk for obesity, by virtue of parental obesity, and lean adolescents at low-risk for obesity, by virtue of lean parents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test whether high-risk youth show abnormalities in consummatory and anticipatory food reward relative to low-risk youth
Time Frame: up to 3 years
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Using fMRI to test whether high-risk youth for obesity show differential neural responses in the striatum, and oral somatosensory and gustatory related brain regions when anticipating and during intake of a palatable food, relative to youth at low risk for obesity.
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up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test the hypothesis that individuals showing abnormalities in anticipatory and consummatory food reward are at increased risk for future weight gain and obesity onset over a 3-year follow-up
Time Frame: up to 3 years
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Determine whether those showing hyper-brain activation during anticipation and intake of a palatable food (via fMRI) gain more body weight over a three year period.
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up to 3 years
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Winter SR, Yokum S, Stice E, Osipowicz K, Lowe MR. Elevated reward response to receipt of palatable food predicts future weight variability in healthy-weight adolescents. Am J Clin Nutr. 2017 Apr;105(4):781-789. doi: 10.3945/ajcn.116.141143. Epub 2017 Feb 22.
- Burger KS, Stice E. Elevated energy intake is correlated with hyperresponsivity in attentional, gustatory, and reward brain regions while anticipating palatable food receipt. Am J Clin Nutr. 2013 Jun;97(6):1188-94. doi: 10.3945/ajcn.112.055285. Epub 2013 Apr 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK080760-01
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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