ObesityNCT01623440
Food Reward in Native American Women
An observational study of Obesity, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Naltrexone and fMRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Self-identified Native American women between ages of 18 and 45.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Neural Correlates of 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.
Read the 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:
- 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.
- Conditions
- Obesity
- Being tested
- Placebo and fMRI, Naltrexone and fMRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo and fMRICombination product
Pill form, participant dosed one time an hour before fMRI.
Naltrexone and fMRICombination product
50 mg pill given one time, one hour before fMRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Placebo and fMRI; Combination Product: Naltrexone and fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI activation in the brain in response to visual food cue
fMRI activation in the brain in response to visual food cue
Measured: With In 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startNov 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Beckman, MD, MPH, Principal investigator, Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623440
- Sponsor's protocol ID
- 10152
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2012
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Food Reward in Native American Women
- ClinicalTrials.gov ID
- NCT01623440
- Acronym / sponsor ID
- 10152
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo/Naltrexone and fMRI | – | Combination Product: Placebo and fMRI, Combination Product: Naltrexone and fMRIA placebo or Naltrexone will be given before fMRI. All participants will undergo both procedures. Naltrexone/placebo are not used as an intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Self-identified Native American women between ages of 18 and 45.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo and fMRIPill form, participant dosed one time an hour before fMRI. | Combination product | Placebo/Naltrexone and fMRI |
| Naltrexone and fMRI50 mg pill given one time, one hour before fMRI | Combination product | Placebo/Naltrexone and fMRI |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Beckman, MD, MPH principal investigator
Division of Endocrinology, Diabetes & Metabolism, University of Minnesota Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI activation in the brain in response to visual food cue (time frame: With In 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.