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Trial record 4 of 21 for:    native american AND (woman OR women OR female)

Food Reward in Native American Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01623440
Recruitment Status : Active, not recruiting
First Posted : June 20, 2012
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Placebo Drug: Naltrexone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neural Correlates of Food Reward in Native American Women
Study Start Date : November 2009
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Naltrexone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Obese
BMI over 30
Drug: Placebo
Pill form, participant dosed one time an hour before fMRI.
Drug: Naltrexone
50 mg pill given one time, one hour before fMRI
Lean
BMI between 20 and 24.9
Drug: Placebo
Pill form, participant dosed one time an hour before fMRI.
Drug: Naltrexone
50 mg pill given one time, one hour before fMRI


Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623440


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Tiffany Beckman, MD, MPH Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01623440     History of Changes
Other Study ID Numbers: 10152
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents