The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Donders Centre for Cognitive Neuroimaging
• Collaborators: HAN University of Applied Sciences; Radboud University Medical Center
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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