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

Phase 1

• Conditions: ow-grade inflammation in obesity; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-004919-11-NL
• Lead Sponsor: Donders Institute for Brain, Cognition and Behaviour, Radboud University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 60

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;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.

Secondary Outcome Measures

Name	Time	Method
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.