The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study
- Conditions
- obesityoverweight10003018
- Registration Number
- NL-OMON54468
- Lead Sponsor
- Radboud Universiteit Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
General inclusion criteria:
• BMI >= 30 kg/m2
• Female sex
• Age: 18-59 years
• 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 at
least 4 weeks after the first measurement (as part of the FLAIR-o study). For
this second measurement the following thresholds for exclusion are: hsCRP >
19.7 for BMI between 30-31 kg/m2 and hsCRP > 27.8 for BMI > 31 kg/m2
• Diagnosed with Diabetes Mellitus type I or II
• Having been vaccinated 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
• 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
• 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, weight-loss, 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcomes are brain activity and behavioural weightings of effort and<br /><br>reward valuation, measured by functional MRI and by a behavioural effort-based<br /><br>decision-making task.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are effort- and reward-related food intake in the lab,<br /><br>anhedonia, reward anticipation, and active behaviour in daily life, measured by<br /><br>Experience Sampling Method, and qualitative interviews.</p><br>