Food Reward in Native American Women

NCT ID: NCT01623440

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2015-07-31

Brief 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.

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.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Placebo and fMRI

Intervention Type: COMBINATION_PRODUCT

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

Naltrexone and fMRI

Intervention Type: COMBINATION_PRODUCT

50 mg pill given one time, one hour before fMRI

Interventions

Placebo and fMRI

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

Intervention Type: COMBINATION_PRODUCT

Naltrexone and fMRI

50 mg pill given one time, one hour before fMRI

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Beckman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

10152

Identifier Type: -

Identifier Source: org_study_id