Food Reward in Native American Women

Neural Correlates of Food Reward in Native American Women

This study aims to characterize the neurobiology of obesity in American Indians (AI) using functional MRIs to examine the correlation between brain response to food stimuli in AI women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI women look at images of fattening food, non-fattening food and non-food objects. Additionally examined is the effect of the drug naltrexone to suppress brain response to visual food cues and calorie intake in the women.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Combination product: Placebo and fMRI; Combination product: Naltrexone and fMRI

Detailed Description

The study looks at both obese and lean women. Each woman comes in for two visits. Each woman takes both the Naltrexone or placebo (one during each visit). Research staff and participants are blinded. Drugs are not used as treatment, but rather to provide information for possible future treatments.

Hypotheses are:

1. Compared with their lean counterparts, obese women will demonstrate more fMRI activation in the brain in response to visual food cues.
2. Naltrexone will reduce the activation in reward-relevant brain sites in response to viewing photographs of fattening food as compared in placebo in both groups.
3. Naltrexone will suppress spontaneous intake of food in obese and lean AI women.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Self-identified Native American women between ages of 18 and 45.

Description

Inclusion Criteria:

• Female
• Self-identified AI
• BMI over 30 OR between 20 and 24.9
• Must see clearly with or without glasses
• Capable of giving informed consent

Exclusion Criteria:

• Smokes more than one cigarette a day
• Drinks more than two alcoholic drinks a day
• Uses recreational drugs
• Is pregnant
• Has had weight loss surgery
• Other major medical problems (e.g. diabetes)
• Taking medications that alter appetite or body weight
• Significant food allergies

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Placebo/Naltrexone and fMRI; A placebo or Naltrexone will be given before fMRI. All participants will undergo both procedures. Naltrexone/placebo are not used as an intervention.	Combination product: Placebo and fMRI; Pill form, participant dosed one time an hour before fMRI.; Combination product: Naltrexone and fMRI; 50 mg pill given one time, one hour before fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI activation in the brain in response to visual food cue	fMRI activation in the brain in response to visual food cue	With In 30days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Tiffany Beckman, MD, MPH, Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 10152

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
• product manufactured in and exported from the U.S.: No