The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects (FTO)

May 22, 2013 updated by: Uppsala University

Investigating the Role of the FTO Gene in Reward System Activation During Visual Presentation of Food Images With fMRI Technique

In order to investigate if individuals, carrying genetic variants predisposing to obesity, respond differently to visual presented food images than non-carriers the investigators aim to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40 subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be selected for the second step in the study. This part involves the fMRI technique to visualize the brain response, focus on reward system activation, when food images are visually presented in the scanner. Factors regarding eating behavior, sleep, physical exercise and relation to food are investigated in the first part of the study as well as clinical parameters such as BMI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 752 72
      • Uppsala, Uppsala County, Sweden
        • Recruiting
        • dep. Neuroscience, Uppsala University
        • Contact:
        • Principal Investigator:
          • Christian Benedict, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No medications (except contraceptives including estrogen)
  • No metabolic disorders/diseases
  • Right handed
  • Color vision
  • Normal sleep-wake rhythm (eg. shift workers can not participate)

Exclusion Criteria:

  • Specific preferences of food, for example vegetarians
  • Grandparents originating from country outside the Nordic area
  • Metallic implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risk allele carriers
Individuals homozygous for the risk allele (A/A) The interventions administrated to this group: 'Blood sampling for genetic analyse', 'Stroop test', 'fMRI'
Procedure: Blood sampling for genetic analyse
Blood sampling are performed at the initiation visit in order to screen for allele variants
Behavioral: Stroop test
Selective attention test where subjects, in one minute, names the ink color of several words without naming the word itself.
Other: fMRI
Functional Magnetic Resonance Imaging, performed to view brain activity
Experimental: Non risk allele carriers
Individuals homozygous for the non-risk allele (T/T) The interventions administrated to this group: 'Blood sampling for genetic analyse', 'Stroop test', 'fMRI'
Procedure: Blood sampling for genetic analyse
Blood sampling are performed at the initiation visit in order to screen for allele variants
Behavioral: Stroop test
Selective attention test where subjects, in one minute, names the ink color of several words without naming the word itself.
Other: fMRI
Functional Magnetic Resonance Imaging, performed to view brain activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genotyping for variants in the FTO gene associated with overweight and obesity
Time Frame: Blood sampling for genetic analyse is performed at the initiation visit
Blood sampling for genetic analyse is performed at the initiation visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Christian Benedict, PhD, dep. Neuroscience, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • LSF008786

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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