obesity overweight
Conditions
Interventions
During the intervention period of 12 weeks, participants will receive one
tablet of 0.5 mg colchicine per day, or one tablet of placebo per day.
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed