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

Obesity Clinical Trial

— FTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01863212
• Other study ID #: LSF008786
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 22, 2013
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: May 2013
• Source: Uppsala University
• Contact: Christian Benedict, PhD
• Email: christian.benedict[@]neuro.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 37 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Eating Behavior
• Obesity

Intervention

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

Locations

Country	Name	City	State
Sweden	dep. Neuroscience, Uppsala University	Uppsala	Uppsala County
Sweden	Uppsala University	Uppsala	Uppsala County

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotyping for variants in the FTO gene associated with overweight and obesity		Blood sampling for genetic analyse is performed at the initiation visit	No