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The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity (FLAIR-i)

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Colchicine 0.5 MG
Placebo
Sponsored by
Donders Centre for Cognitive Neuroimaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Inflammation, fMRI, Motivation

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: BMI ≥ 27 kg/m2 Female sex Right-handed Age: 18-59 years Shoulder width of < 68 cm (to fit into the MRI scanner) Dutch speaking - Sufficient level to understand task instructions Low-grade inflammatory state, as measured by C-reactive protein (CRP) between 3.0 and 10.0 mg/L Exclusion Criteria: Having been vaccinated by any type of vaccine 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 Diagnosed with Diabetes Mellitus type I or II 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 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 Have renal impairment as evidenced by serum creatinine >150 μmol/l or eGFR <50mL/min/1.73m2, determined maximum 12 weeks before inclusion Have moderate to severe hepatic disease (History of) clinically significant psychiatric or neurological disorder (History of) clinically significant metabolic, cardiovascular, renal, liver, endocrinological, autoimmune or chronic inflammatory disease General medical conditions, such as sensorimotor handicaps, deafness, blindness or colour-blindness, as judged by the investigator Current or history of alcohol and/or drugs abuse (i.e. >14 units per week) Habitual smoking, i.e. one or more cigarettes per day Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit Participation in another weight loss, lifestyle or anti-inflammatory intervention in the context of research at the time of inclusion or during the study Contraindications for MRI

Sites / Locations

  • Donders Centre for Cognitive NeuroimagingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

One tablet of colchicine 0.5 mg per day

One tablet of microcrystalline cellulose per day

Outcomes

Primary Outcome Measures

Change in effort valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of effort sensitivity, as measured by an effort-based decision making task.
Change in reward valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of reward sensitivity, as measured by an effort-based decision making task.

Secondary Outcome Measures

Change effort/reward related food intake ratio
Intake of food items varying in effort and reward/calories, measured by a bogus food taste test.
Change in reward anticipation/reward consummation ratio in daily life
Reward anticipation and reward consummation scores in daily life as measured by the Experience Sampling Method

Full Information

First Posted
September 27, 2022
Last Updated
March 14, 2023
Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Radboud University Medical Center, HAN University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05785429
Brief Title
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity
Acronym
FLAIR-i
Official Title
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity: the FLAIR-i Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Radboud University Medical Center, HAN University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo.
Detailed Description
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, the investigators hypothesise that low-grade inflammation is causing altered striatal brain responses and effortless 'fast food' choices in overweight and obesity. The objective of this study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obese participants, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo. In addition, it will be investigated whether this primary objective translates to more ecologically valid measures/settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Inflammation, fMRI, Motivation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Description
One tablet of colchicine 0.5 mg per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet of microcrystalline cellulose per day
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG
Intervention Description
Participant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants in the intervention group receive one tablet of placebo per day for 12 weeks.
Primary Outcome Measure Information:
Title
Change in effort valuation in brain and behaviour
Description
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of effort sensitivity, as measured by an effort-based decision making task.
Time Frame
Change between baseline and follow-up after 12 weeks
Title
Change in reward valuation in brain and behaviour
Description
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of reward sensitivity, as measured by an effort-based decision making task.
Time Frame
Change between baseline and follow-up after 12 weeks
Secondary Outcome Measure Information:
Title
Change effort/reward related food intake ratio
Description
Intake of food items varying in effort and reward/calories, measured by a bogus food taste test.
Time Frame
Change between baseline and follow-up after 12 weeks
Title
Change in reward anticipation/reward consummation ratio in daily life
Description
Reward anticipation and reward consummation scores in daily life as measured by the Experience Sampling Method
Time Frame
Change between baseline and follow-up after 12 weeks
Other Pre-specified Outcome Measures:
Title
C-reactive protein
Description
High sensitive C-reactive protein measured in plasma
Time Frame
Change between baseline and follow-up after 12 weeks
Title
Inflammation profile (blood)
Description
Assay-based profile of systemic inflammation measured in plasma stimulation, Olink Inflammatory profile
Time Frame
Change between baseline and follow-up after 12 weeks
Title
Brain myo-inositol levels
Description
Brain myo-inositol levels reflecting neuroinflammation in ventral striatum and ACC, measured by magnetic resonance spectroscopy
Time Frame
Change between baseline and follow-up after 12 weeks
Title
Abdominal fat distribution
Description
VAT(visceral adipose tissue)/SAT(subcutaneous adipose tissue) ratio based on abdominal MRI scan
Time Frame
Change between baseline and follow-up after 12 weeks
Title
(Resting state) functional connectivity networks
Description
Measured by functional MRI
Time Frame
Change between baseline and follow-up after 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI ≥ 27 kg/m2 Female sex Right-handed Age: 18-59 years Shoulder width of < 68 cm (to fit into the MRI scanner) Dutch speaking - Sufficient level to understand task instructions Low-grade inflammatory state, as measured by C-reactive protein (CRP) between 3.0 and 10.0 mg/L Exclusion Criteria: Having been vaccinated by any type of vaccine 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 Diagnosed with Diabetes Mellitus type I or II 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 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 Have renal impairment as evidenced by serum creatinine >150 μmol/l or eGFR <50mL/min/1.73m2, determined maximum 12 weeks before inclusion Have moderate to severe hepatic disease (History of) clinically significant psychiatric or neurological disorder (History of) clinically significant metabolic, cardiovascular, renal, liver, endocrinological, autoimmune or chronic inflammatory disease General medical conditions, such as sensorimotor handicaps, deafness, blindness or colour-blindness, as judged by the investigator Current or history of alcohol and/or drugs abuse (i.e. >14 units per week) Habitual smoking, i.e. one or more cigarettes per day Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit Participation in another weight loss, lifestyle or anti-inflammatory intervention in the context of research at the time of inclusion or during the study Contraindications for MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Scholing, MSc.
Phone
+31 6 3113 2140
Email
judith.scholing@donders.ru.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Aarts, Prof.dr.
Organizational Affiliation
Donders Centre for Cognitive Neuroimaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donders Centre for Cognitive Neuroimaging
City
Nijmegen
ZIP/Postal Code
9525EN
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Scholing, MSc.
Phone
+31 6 3113 2140
Email
judith.scholing@donders.ru.nl
First Name & Middle Initial & Last Name & Degree
Esther Aarts, Prof.dr.
Phone
+31 6 3113 2617
Email
esher.aarts@donders.ru.nl

12. IPD Sharing Statement

Learn more about this trial

The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity

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