The effect of the anti-inflammatory drug colchicine on brain and behaviour in overweight and obesity: the FLAIR-i study.

The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study. - FLAIR-i

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004919-11-NL

Enrollment

Registered

2022-01-19

Start date

2022-05-03

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-grade inflammation in obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 24.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Colchicine CF 0,5mg Product Name: Colchicine CF 0,5 mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General inclusion criteria: • BMI = 30 kg/m2 • Female sex • Age: 18-59 years • Right-handed • Low-grade inflammation, as defined by C-reactive protein (hsCRP) between 3.0 and 10.0 mg/L for BMI between 30-31 kg/m2, and hsCRP between 3.0 and 22.1 mg/L for BMI > 31 kg/m2. In case of a hsCRP level above these thresholds, the measurement is repeated after at least 4 weeks (as part of the FLAIR-o study, NL77503.091.21). For this second measurement the thresholds for inclusion are: hsCRP 3.0-19.7 for BMI between 30-31 kg/m2 and hsCRP 3.0-27.8 for BMI > 31 kg/m2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Diagnosed with Diabetes Mellitus type I or II • Having been vaccinated in the 4 weeks preceding the first test session • Gained or lost >5 kg of body weight over the last 6 months • Followed an energy restricting diet during the last 2 months • Habitual smoking, i.e. one or more cigarettes per day • Current or history of alcohol and/or drugs abuse (i.e. >14 units per week) • Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit (self-reported) • (History of) clinically significant psychiatric or neurological disorder • (History of) clinically significant metabolic, cardiovascular, renal, endocrinological, autoimmune or chronic inflammatory disease • General medical conditions, such as sensorimotor handicaps, deafness, blindness or colorblindness, as judged by the investigator • Regular use of anti-inflammatory, anti-diabetic, anti-histamine and psychoactive medication • Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, statins, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine • Renal impairment as evidenced by serum creatinine >150 µmol/l or eGFR <50mL/min/1.73m2 • Have moderate to severe hepatic disease • Contraindications for fMRI

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in obese participants by employing a placebo-controlled intervention design with the anti-inflammatory agent colchicine. ;Secondary Objective: To study whether the primary objective translate to more ecologically valid measures/settings.;Primary end point(s): The main outcomes are brain activity and behavioural weightings of effort and reward valuation, measured by functional MRI and by a behavioural effort-based decision-making task.;Timepoint(s) of evaluation of this end point: At baseline (as part of a larger observatory study, the FLAIR-o) and after the trial period.	—

Measure

Time frame

Main Objective: To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in obese participants by employing a placebo-controlled intervention design with the anti-inflammatory agent colchicine. ;Secondary Objective: To study whether the primary objective translate to more ecologically valid measures/settings.;Primary end point(s): The main outcomes are brain activity and behavioural weightings of effort and reward valuation, measured by functional MRI and by a behavioural effort-based decision-making task.;Timepoint(s) of evaluation of this end point: At baseline (as part of a larger observatory study, the FLAIR-o) and after the trial period.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are effort- and reward-related food intake in the lab, anhedonia, reward anticipation, and active behaviour in daily life, measured by Experience Sampling Method and qualitative interviews.;Timepoint(s) of evaluation of this end point: At baseline (as part of a larger observational study, the FLAIR-o study, NL77503.091.21) and after the intervention period.	—

Measure

Time frame

Secondary end point(s): Secondary outcomes are effort- and reward-related food intake in the lab, anhedonia, reward anticipation, and active behaviour in daily life, measured by Experience Sampling Method and qualitative interviews.;Timepoint(s) of evaluation of this end point: At baseline (as part of a larger observational study, the FLAIR-o study, NL77503.091.21) and after the intervention period.

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Countries

Netherlands

Contacts

Public ContactStudy team

Donders Institute for Brain, Cognition and Behaviour

flairstudie@donders.ru.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026