NCT05785429

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Donders Centre for Cognitive Neuroimaging · Academic / Other
• Sex: Female
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG	Participant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks.
DRUG	Placebo	Participants in the intervention group receive one tablet of placebo per day for 12 weeks.

Timeline

• Start date: 2022-08-02
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2023-03-27
• Last updated: 2025-09-02

Locations

1 site across 1 country: Netherlands