Overweight and ObesityFLAIR-iNCT05785429
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity
A study testing Colchicine 0.5 MG in people with Overweight and Obesity, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
Trial summary
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Aug 2022to 20 Jan 2025
- 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 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 27 kg/m2
- Female sex
- Right-handed
- Age: 18-59 years
- Shoulder width of < 68 cm (to fit into the MRI scanner)
- Dutch speaking - Sufficient level to understand task instructions
- Low-grade inflammatory state, as measured by C-reactive protein (CRP) between 3.0 and 10.0 mg/L
Who cannot join
- Having been vaccinated by any type of vaccine in the 4 weeks preceding the first test session
- Having had an infection characterized by a fever, or diagnosed by a medical physician in the 4 weeks preceding the first test session
- Diagnosed with Diabetes Mellitus type I or II
- Gained or lost >2 points in BMI (kg/m2) over the last 6 months
- Followed an energy restricting diet during the last 2 months
- Having had bariatric surgery in the past 5 years
Show all 18Show fewer
- Regular use of anti-inflammatory, anti-diabetic, weight-loss, and psychoactive medication
- Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, statins, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
- Have renal impairment as evidenced by serum creatinine >150 μmol/l or eGFR <50mL/min/1.73m2, determined maximum 12 weeks before inclusion
- Have moderate to severe hepatic disease
- (History of) clinically significant psychiatric or neurological disorder
- (History of) clinically significant metabolic, cardiovascular, renal, liver, endocrinological, autoimmune or chronic inflammatory disease
- General medical conditions, such as sensorimotor handicaps, deafness, blindness or colour-blindness, as judged by the investigator
- Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
- Habitual smoking, i.e. one or more cigarettes per day
- Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit
- Participation in another weight loss, lifestyle or anti-inflammatory intervention in the context of research at the time of inclusion or during the study
- Contraindications for MRI
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Centre for Cognitive Neuroimaging
Nijmegen, 9525EN
About this study
Official title: The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity: the FLAIR-i Study
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo.
Read the detailed description
Obesity is a major health problem worldwide and is characterized by increases in low-grade, systemic inflammation. Outside the field of obesity, increases in inflammation have been related to loss of motivation and effortful behaviour, which can be objectively measured with effort-based decision making in brain and behaviour. Here, the investigators hypothesise that low-grade inflammation is causing altered striatal brain responses and effortless 'fast food' choices in overweight and obesity. The objective of this study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obese participants, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo. In addition, it will be investigated whether this primary objective translates to more ecologically valid measures/settings.
- Conditions
- Overweight and Obesity
- Being tested
- Colchicine 0.5 MG, Placebo
- Keywords
- Overweight, Obesity, Inflammation, fMRI, Motivation
- Medical subject headings
- Overweight, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Participant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks.
PlaceboDrug
Participants in the intervention group receive one tablet of placebo per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | One tablet of colchicine 0.5 mg per day Receives: Drug: Colchicine 0.5 MG |
| Placebo | Placebo comparator | One tablet of microcrystalline cellulose per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in effort valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of effort sensitivity, as measured by an effort-based decision making task.
Measured: Change between baseline and follow-up after 12 weeks
Change in reward valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of reward sensitivity, as measured by an effort-based decision making task.
Measured: Change between baseline and follow-up after 12 weeks
Secondary outcomes (2)
Change effort/reward related food intake ratio
Intake of food items varying in effort and reward/calories, measured by a bogus food taste test.
Measured: Change between baseline and follow-up after 12 weeks
Change in reward anticipation/reward consummation ratio in daily life
Reward anticipation and reward consummation scores in daily life as measured by the Experience Sampling Method
Measured: Change between baseline and follow-up after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start2 Aug 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Cognitive Neuroimaging
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, HAN University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Esther Aarts, Prof.dr., Principal investigator, Donders Centre for Cognitive Neuroimaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785429
- Sponsor's protocol ID
- 3033002.01
- Other IDs
- 2021-004919-11
- Acronym
- FLAIR-i
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity: the FLAIR-i Study
- ClinicalTrials.gov ID
- NCT05785429
- Acronym / sponsor ID
- FLAIR-i / 3033002.01
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Inflammation, fMRI, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Donders Centre for Cognitive NeuroimagingUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, HAN University of Applied Sciences
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 27 Mar 2023 (actual)
- 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.
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo.
Detailed description
Obesity is a major health problem worldwide and is characterized by increases in low-grade, systemic inflammation. Outside the field of obesity, increases in inflammation have been related to loss of motivation and effortful behaviour, which can be objectively measured with effort-based decision making in brain and behaviour. Here, the investigators hypothesise that low-grade inflammation is causing altered striatal brain responses and effortless 'fast food' choices in overweight and obesity. The objective of this study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obese participants, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo. In addition, it will be investigated whether this primary objective translates to more ecologically valid measures/settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine 0.5 MGOne tablet of colchicine 0.5 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet of microcrystalline cellulose per day |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI ≥ 27 kg/m2
- Female sex
- Right-handed
- Age: 18-59 years
- Shoulder width of < 68 cm (to fit into the MRI scanner)
Key exclusion criteria (18 listed)
- Having been vaccinated by any type of vaccine in the 4 weeks preceding the first test session
- Having had an infection characterized by a fever, or diagnosed by a medical physician in the 4 weeks preceding the first test session
- Diagnosed with Diabetes Mellitus type I or II
- Gained or lost >2 points in BMI (kg/m2) over the last 6 months
- Followed an energy restricting diet during the last 2 months
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 |
|---|---|---|
| Colchicine 0.5 MGParticipant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks. | Drug | Colchicine |
| PlaceboParticipants in the intervention group receive one tablet of placebo per day for 12 weeks. | Drug | Placebo |
Primary outcome
Change in effort valuation in brain and behaviour
Time frame: Change between baseline and follow-up after 12 weeks
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of effort sensitivity, as measured by an effort-based decision making task.
Change in reward valuation in brain and behaviour
Time frame: Change between baseline and follow-up after 12 weeks
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of reward sensitivity, as measured by an effort-based decision making task.
2 secondary outcomes
Change effort/reward related food intake ratio
Time frame: Change between baseline and follow-up after 12 weeks
Change in reward anticipation/reward consummation ratio in daily life
Time frame: Change between baseline and follow-up after 12 weeks
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 2 Sep 2025.
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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.
Esther Aarts, Prof.dr. principal investigator
Donders Centre for Cognitive Neuroimaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine 0.5 MG in people with Overweight and Obesity, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
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 7 inclusion and 18 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 2 Sep 2025. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Change in effort valuation in brain and behaviour (time frame: Change between baseline and follow-up after 12 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2025.