obesity overweight
Conditions
Interventions
During the intervention period of 12 weeks, participants included in the trial
will receive 1 tablet of 0.5mg colchicine or 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
Exclusion criteria
Exclusion criteria: • Presence of acute infection, indicated by high-sensitive C-reactive protein (hsCRP) > 10.0 mg/L for BMI between 30-31 kg/m2 and hsCRP > 22.1 mg/L for BMI > 31 kg/m2 at day of testing*. In case of a hsCRP level above these thresholds, the measurement is repeated at least 4 weeks after the first measurement, for this second measurement the 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 • Contraindications for fMRI
Design outcomes
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. | — |
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. | — |
Countries
Netherlands
Outcome results
None listed