Food Reward in Native American Women

NCT01623440 | Completed

• 1 other identifier: 10152
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Combination Product: Naltrexone and fMRI

Interventions

Placebo and fMRI COMBINATION_PRODUCT

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

Placebo/Naltrexone and fMRI

Naltrexone and fMRI COMBINATION_PRODUCT

50 mg pill given one time, one hour before fMRI

Placebo/Naltrexone and fMRI

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females Only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Tiffany Beckman, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 20, 2012
• Study Start: November 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)