ObesityFTONCT01863212
The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects
A study testing Blood sampling for genetic analyse, Stroop test and fMRI in people with Obesity and Eating Behavior, run by Uppsala University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Behavior
- What is being tested?
- Blood sampling for genetic analyse, Stroop test and fMRI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2010to Sep 2014
- Phase
- Interventional
- 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 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No medications (except contraceptives including estrogen)
- No metabolic disorders/diseases
- Right handed
- Color vision
- Normal sleep-wake rhythm (eg. shift workers can not participate)
Who cannot join
- Specific preferences of food, for example vegetarians
- Grandparents originating from country outside the Nordic area
- Metallic implants
Trial locations and contacts
2 sites in 1 country.
Christian Benedict, PhD contact
Sweden2 sites, 2 recruiting
- Recruiting
Uppsala University
Uppsala, Uppsala County, 752 72
christian.benedict@neuro.uu.se
- Recruiting
dep. Neuroscience, Uppsala University
Uppsala, Uppsala County
Christian Benedict, PhD, christian.benedict@neuro.uu.se
Christian Benedict, PhD
About this study
Official title: 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.
- Conditions
- Obesity, Eating Behavior
- Being tested
- Blood sampling for genetic analyse, Stroop test, fMRI
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for genetic analyseProcedure or surgery
Blood sampling are performed at the initiation visit in order to screen for allele variants
Stroop testBehavioural
Selective attention test where subjects, in one minute, names the ink color of several words without naming the word itself.
fMRIOther
Functional Magnetic Resonance Imaging, performed to view brain activity
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: Procedure: Blood sampling for genetic analyse; Behavioral: Stroop test; Other: 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' Receives: Procedure: Blood sampling for genetic analyse; Behavioral: Stroop test; Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping for variants in the FTO gene associated with overweight and obesity
Measured: Blood sampling for genetic analyse is performed at the initiation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Benedict, PhD, Principal investigator, dep. Neuroscience, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863212
- Sponsor's protocol ID
- LSF008786
- Acronym
- FTO
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40759193Andreoli MF, Kruger AL, Sokolov AV, Rukh G, De Francesco PN, Perello M, Schioth HB. LEAP2 is associated with impulsivity and reward sensitivity depending on the nutritional status and decreases with protein intake in humans. Diabetes Obes Metab. 2024 Oct;26(10):4734-4743. doi: 10.1111/dom.15850. Epub 2024 Aug 14.
PubMed 39140219Wiemerslage 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.
PubMed 28194012
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of the FTO Gene in Reward System Activation During Visual Presentation of Food Images With fMRI Technique
- ClinicalTrials.gov ID
- NCT01863212
- Acronym / sponsor ID
- FTO / LSF008786
- Conditions
- Obesity, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 27 May 2013 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk allele carriers | Experimental | Procedure: Blood sampling for genetic analyse, Behavioral: Stroop test, Other: fMRIIndividuals homozygous for the risk allele (A/A) The interventions administrated to this group: 'Blood sampling for genetic analyse', 'Stroop test', 'fMRI' |
| Non risk allele carriers | Experimental | Procedure: Blood sampling for genetic analyse, Behavioral: Stroop test, Other: fMRIIndividuals homozygous for the non-risk allele (T/T) The interventions administrated to this group: 'Blood sampling for genetic analyse', 'Stroop test', 'fMRI' |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No medications (except contraceptives including estrogen)
- No metabolic disorders/diseases
- Right handed
- Color vision
- Normal sleep-wake rhythm (eg. shift workers can not participate)
Key exclusion criteria (3 listed)
- Specific preferences of food, for example vegetarians
- Grandparents originating from country outside the Nordic area
- Metallic implants
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 |
|---|---|---|
| Blood sampling for genetic analyseBlood sampling are performed at the initiation visit in order to screen for allele variants | Procedure or surgery | Non risk allele carriers, Risk allele carriers |
| Stroop testSelective attention test where subjects, in one minute, names the ink color of several words without naming the word itself. | Behavioural | Non risk allele carriers, Risk allele carriers |
| fMRIFunctional Magnetic Resonance Imaging, performed to view brain activity | Other | Non risk allele carriers, Risk allele carriers |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Derived from this study: PubMed 40759193Andreoli 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.
- Derived from this study: PubMed 39140219Andreoli MF, Kruger AL, Sokolov AV, Rukh G, De Francesco PN, Perello M, Schioth HB. LEAP2 is associated with impulsivity and reward sensitivity depending on the nutritional status and decreases with protein intake in humans. Diabetes Obes Metab. 2024 Oct;26(10):4734-4743. doi: 10.1111/dom.15850. Epub 2024 Aug 14.
- Derived from this study: PubMed 28194012Wiemerslage 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.
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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.
Christian Benedict, PhD contact
Christian Benedict, PhD principal investigator
dep. Neuroscience, Uppsala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for genetic analyse, Stroop test and fMRI in people with Obesity and Eating Behavior, run by Uppsala University at 2 sites in Sweden.
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 3 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: status not confirmed, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Benedict, PhD (christian.benedict@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863212, which also lists 3 linked publications.
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 27 May 2013.