NCT01863212

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

4 years

First QC Date

May 21, 2013

Last Update Submit

May 22, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Genotyping for variants in the FTO gene associated with overweight and obesity

    Blood sampling for genetic analyse is performed at the initiation visit

Study Arms (2)

Risk allele carriers

EXPERIMENTAL

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 analyseBehavioral: Stroop testOther: fMRI

Non risk allele carriers

EXPERIMENTAL

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 analyseBehavioral: Stroop testOther: fMRI

Interventions

Blood sampling are performed at the initiation visit in order to screen for allele variants

Non risk allele carriersRisk allele carriers
Stroop testBEHAVIORAL

Selective attention test where subjects, in one minute, names the ink color of several words without naming the word itself.

Non risk allele carriersRisk allele carriers
fMRIOTHER

Functional Magnetic Resonance Imaging, performed to view brain activity

Non risk allele carriersRisk allele carriers

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uppsala University

Uppsala, Uppsala County, 752 72, Sweden

RECRUITING

dep. Neuroscience, Uppsala University

Uppsala, Uppsala County, Sweden

RECRUITING

Related Publications (2)

  • Andreoli MF, De Francesco PN, Titova OE, Perello M, Schioth HB. Plasma LEAP2 concentration is associated with attention and cognitive responses to low-calorie food cues in men depending on body weight status. Physiol Behav. 2025 Nov 1;301:115049. doi: 10.1016/j.physbeh.2025.115049. Epub 2025 Aug 7.

  • Wiemerslage L, Islam R, van der Kamp C, Cao H, Olivo G, Ence-Eriksson F, Castillo S, Larsen AL, Bandstein M, Dahlberg LS, Perland E, Gustavsson V, Nilsson J, Vogel H, Schurmann A, Larsson EM, Rask-Andersen M, Benedict C, Schioth HB. A DNA methylation site within the KLF13 gene is associated with orexigenic processes based on neural responses and ghrelin levels. Int J Obes (Lond). 2017 Jun;41(6):990-994. doi: 10.1038/ijo.2017.43. Epub 2017 Feb 14.

MeSH Terms

Conditions

ObesityFeeding Behavior

Interventions

Blood Specimen CollectionStroop Test

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Christian Benedict, PhD

    dep. Neuroscience, Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Benedict, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 27, 2013

Study Start

September 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations