Primary Objectives: • To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in overweight and obese participants by employing a placebo-controlled intervention design with the anti-…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Obesity is a major health problem worldwide and is characterized by increases
in low-grade, systemic inflammation. Outside the field of obesity, increases in
inflammation have been related to loss of motivation and effortful behaviour,
which can be objectively measured with effort-based decision making in brain
and behaviour. Here, we hypothesise that low-grade inflammation is causing
altered striatal brain responses and effortless *fast food* choices in
overweight and obesity.
Study objective
Primary Objectives:
• To study the causal role of inflammation in affecting food-related
effort-based decision making in brain and behaviour in overweight and obese
participants by employing a placebo-controlled intervention design with the
anti-inflammatory agent colchicine.
Secondary Objective:
• To study whether the primary objective translates to more ecologically valid
measures/settings.
Study design
The study has a double-blind placebo-controlled intervention design.
Intervention
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.
Study burden and risks
Participants will come to the research centre for an intake appointment of 30
minutes, during which the screening will take place. Hereafter, participants
will come to the research centre two more times for an appointment of 4,5 hours
(a baseline and follow-up visit). During these two visits, participants will do
behavioural tasks in the MRI scanner, a food intake test, fill out
questionnaires, a blood sample will be drawn and anthropometric measurements
will be performed. In the week between the intake and the first longer
appointment, participants will fill out 10 short questionnaires per day on
their phone for 7-10 consecutive days. Participants will then receive
colchicine/placebo for 12 weeks, which can be administered safely to healthy
women with a high BMI without any known risks of serious adverse events. In the
last week of the intervention, participants will again fill out 10 short
questionnaires per day on their phone for 7-10 consecutive days. After the
intervention period, participants will come back to the research centre for the
follow-up visit, during which the same measurements will be done as during the
baseline appointment.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
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
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-004919-11-NL |
| CCMO | NL79408.091.21 |