Food Reward in Native American Women
This trial is active, not recruiting.
|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|
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.
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator)|
fMRI activation in the brain in response to visual food cue
time frame: With In 30days
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
|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.|
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