Relation of Consummatory and Anticipatory Food Reward to Obesity

Weight Gain Clinical Trial

Official title:

Relation of Consummatory and Anticipatory Food Reward to Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807572
• Other study ID #: DK080760-01
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: September 29, 2015
• Start date: June 2009
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 16 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Food Habits
• Weight Gain

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test whether high-risk youth show abnormalities in consummatory and anticipatory food reward relative to low-risk youth	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.	up to 3 years	No
Secondary	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	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.	up to 3 years	No