Investigating how colchicine affects decision-making related to food in overweight individuals
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity: the FLAIR-i Study
This study is testing if the anti-inflammatory drug colchicine can help overweight people make better food choices by reducing inflammation in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | Female |
| Sponsor | Donders Centre for Cognitive Neuroimaging Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT05785429 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of inflammation on decision-making processes related to food choices in individuals with overweight and obesity. It will compare the effects of the anti-inflammatory drug colchicine against a placebo to determine if reducing inflammation can improve effort-based decision-making. Participants will undergo fMRI scans to assess brain responses while making food-related choices. The study will also evaluate whether these findings can be applied to real-world scenarios.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking, right-handed females aged 18-59 with a BMI of 27 or higher and low-grade inflammation.
Not a fit: Patients with diabetes, recent infections, significant weight changes, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies for improving decision-making and motivation in overweight and obese patients.
How similar studies have performed: While the specific approach of using colchicine in this context is novel, previous studies have indicated a link between inflammation and decision-making, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen
- Donders Centre for Cognitive Neuroimaging — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Esther Aarts, Prof.dr. — Donders Centre for Cognitive Neuroimaging
- Study coordinator: Judith Scholing, MSc.
- Email: judith.scholing@donders.ru.nl
- Phone: +31 6 3113 2140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.