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Completed

NCT Number: NCT01623440

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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:

  • Compared with their lean counterparts, obese women will demonstrate more fMRI activation in the brain in response to visual food cues.
  • 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.
  • Naltrexone will suppress spontaneous intake of food in obese and lean AI women.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo and fMRI

Combination Product

Pill form, participant dosed one time an hour before fMRI.

Naltrexone and fMRI

Combination Product

50 mg pill given one time, one hour before fMRI

Primary outcomes

  1. fMRI activation in the brain in response to visual food cue

    Time frame: With In 30days

    fMRI activation in the brain in response to visual food cue

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Neural Correlates of Food Reward in Native American Women

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2012
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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