Primary Objectives: • To study the association between inflammation and food-related effort-based decision making in brain and behaviour in obese participants, taking into account possible other influencing factors in a causal discovery model.…
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, caused by an immune response in visceral
adipose tissue. Approximately 40-60% of the individuals with a BMI > 30 kg/m2
have this increased inflammatory state.
Outside the field of obesity, increases in inflammation have been related to
loss of motivation and effortful behaviour (anhedonia). In several
neuropsychiatric disorders, such as depression and schizophrenia, the level of
low-grade inflammation has even been linked to symptom severity.
In obesity, functional MRI studies additionally show altered activation in the
striatum, a brain area related to motivational behaviour, but the direction and
size of this effect is highly related to the individual and the situation.
Here, we hypothesize that low-grade inflammation is predicting/causing altered
brain responses in the striatum and effortless behaviour, resulting in more
'fast food' choices in obesity.
Study objective
Primary Objectives:
• To study the association between inflammation and food-related effort-based
decision making in brain and behaviour in obese participants, taking into
account possible other influencing factors in a causal discovery model.
Secondary Objective:
• To study whether the two primary objectives translate to more ecologically
valid measures/settings.
Study design
The study has an observational cross-sectional design.
Intervention
During the intervention period of 12 weeks, participants included in the trial
will receive 1 tablet of 0.5mg colchicine or placebo per day.
Study burden and risks
Participants will come to the lab at least one time for ±4.5 hours. During the
visit, participants will perform a behavioural task in the MRI scanner, do a
food intake test, fill out questionnaires, a blood sample will be taken and
anthropometric measurements will be done. In the week after the visit,
participants will fill out 10 short questionnaires per day on their phone for
10-14 consecutive days.
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
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
Recruitment
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 |
|---|---|
| CCMO | NL77503.091.21 |