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

NCT05785429 | Completed DMC

• 2 other identifiers: 3033002.012021-004919-11
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Inflammation; fMRI; Motivation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change between baseline and follow-up after 12 weeks

Secondary Outcomes (2)

• Change effort/reward related food intake ratio

  Change between baseline and follow-up after 12 weeks

• Change in reward anticipation/reward consummation ratio in daily life

  Change between baseline and follow-up after 12 weeks

Other Outcomes (5)

• C-reactive protein

  Change between baseline and follow-up after 12 weeks

• Inflammation profile (blood)

  Change between baseline and follow-up after 12 weeks

• Brain myo-inositol levels

  Change between baseline and follow-up after 12 weeks

Study Arms (2)

Colchicine

EXPERIMENTAL

One tablet of colchicine 0.5 mg per day

Drug: Colchicine 0.5 MG

Placebo

PLACEBO COMPARATOR

One tablet of microcrystalline cellulose per day

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

Participant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks.

Colchicine

Placebo DRUG

Participants in the intervention group receive one tablet of placebo per day for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Donders Centre for Cognitive Neuroimaging: lead
• Radboud University Medical Center: collaborator
• HAN University of Applied Sciences: collaborator

Study Sites (1)

Donders Centre for Cognitive Neuroimaging

Nijmegen, 9525EN, Netherlands

Location

MeSH Terms

Conditions

Overweight; Obesity; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Esther Aarts, Prof.dr.

  Donders Centre for Cognitive Neuroimaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: March 27, 2023
• Study Start: August 2, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

NL (1)