Overview

This trial is active, not recruiting.

Condition obesity
Treatments placebo, naltrexone
Phase phase 4
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date November 2009
End date December 2016
Trial size 75 participants
Trial identifier NCT01623440, 10152

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
BMI over 30
placebo
Pill form, participant dosed one time an hour before fMRI.
naltrexone
50 mg pill given one time, one hour before fMRI
(Other)
BMI between 20 and 24.9
placebo
Pill form, participant dosed one time an hour before fMRI.
naltrexone
50 mg pill given one time, one hour before fMRI

Primary Outcomes

Measure
fMRI activation in the brain in response to visual food cue
time frame: With In 30days

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Neural Correlates of Food Reward in Native American Women
Principal investigator Tiffany Beckman, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.