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    Clinical Trial Results:
    The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study.

    Summary
    EudraCT number
    		 2021-004919-11
    Trial protocol
    		 NL  
    Global end of trial date
    20 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2026
    First version publication date
    21 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FLAIR-i
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05785429
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Donders Institute for Brain, Cognition, and Behaviour, Radboud Univesity
    Sponsor organisation address
    Kapittelweg 29, Nijmegen, Netherlands, 6525 EN
    Public contact
    Study team, Donders Institute for Brain, Cognition and Behaviour, flairstudie@donders.ru.nl
    Scientific contact
    Study team, Donders Institute for Brain, Cognition and Behaviour, flairstudie@donders.ru.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jan 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in obese participants by employing a placebo-controlled intervention design with the anti-inflammatory agent colchicine.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and applicable Dutch legislation. Written informed consent was obtained from all participants prior to enrolment and randomisation. Participants were free to withdraw from the study at any time without providing a reason and without consequences. The study protocol, informed consent procedures, and participant information materials were reviewed and approved by an accredited Medical Research Ethics Committee before study initiation. Participants were monitored for adverse events throughout the study and had access to the research team and study physician during the intervention period. Emergency unblinding procedures were available when medically required. As colchicine was administered solely for research purposes, treatment could be discontinued at any time if adverse effects occurred. To minimize risk, participants underwent screening for eligibility, including assessment of renal function and relevant exclusion criteria such as liver disease and concomitant medications with potential colchicine interactions. Participants' general practitioners were informed of study participation with participant consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were included in the FLAIR-i study in two ways: after participation in the FLAIR-o study (NL77503.091.21), or through recruitment without participation in the FLAIR-o study.

    Pre-assignment
    Screening details
    		 Women aged 18–59 years were screened for eligibility. Inclusion criteria included obesity (BMI >30 kg/m²) and evidence of low-grade inflammation, defined as a C-reactive protein (CRP) concentration >3.0 mg/L.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Colchicine
    Arm description
    		 Participants received one capsule of colchicine 0.5mg daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Colchicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Colchicine, 0.5mg/d, oral administration.

    Arm title
    		 Placebo
    Arm description
    		 Participants received one placebo capsule daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, one capsule/day, oral administration

    Number of subjects in period 1
    		Colchicine Placebo
    Started
    31
    33
    Completed
    28
    31
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Colchicine
    Reporting group description
    		 Participants received one capsule of colchicine 0.5mg daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received one placebo capsule daily.

    Reporting group values
    		 Colchicine Placebo Total
    Number of subjects
    		 31 33 64
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 31 33 64
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ( 11 ) 46 ( 9 ) -
    Gender categorical
    Only women were included in this study.
    Units: Subjects
        Female
    		 31 33 64
        Male
    		 0 0 0
    C-reactive protein
    Units: mg/l
        arithmetic mean (standard deviation)
    		 9.2 ( 6.8 ) 7.2 ( 4.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Colchicine
    Reporting group description
    		 Participants received one capsule of colchicine 0.5mg daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received one placebo capsule daily.

    Primary: Change in low-grade inflammation (INFLA-score)

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    End point title
    		 Change in low-grade inflammation (INFLA-score)
    End point description
    Low-grade inflammation was measured by the INFLA-score, a composite score of C-reactive protein, white blood cell count, neutrophil/lymphocyte ratio and blood platelets.
    End point type
    Primary
    End point timeframe
    Follow-up (at 12 weeks) - Baseline
    End point values
    		 Colchicine Placebo
    Number of subjects analysed
    24
    25
    Units: SD
    arithmetic mean (standard deviation)
        Baseline
    0.08 ( 0.65 )
    -0.13 ( 0.50 )
        Follow-up
    -0.25 ( 0.54 )
    -0.03 ( 0.53 )
    Statistical analysis title
    		 Mixed regression model: Change in INFLA-score
    Comparison groups
    Colchicine v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 -0.04

    Primary: Change in effort aversion

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    End point title
    		 Change in effort aversion
    End point description
    Effort aversion was measured by a food-related effort-based decision making task.
    End point type
    Primary
    End point timeframe
    Follow-up (at 12 weeks) - Baseline
    End point values
    		 Colchicine Placebo
    Number of subjects analysed
    24
    25
    Units: log-odds
    arithmetic mean (standard deviation)
        Baseline
    -4.41 ( 2.06 )
    -4.27 ( 1.57 )
        Follow-up
    -4.61 ( 1.95 )
    -4.73 ( 1.52 )
    Statistical analysis title
    		 Mixed regression model: Change in effort aversion
    Statistical analysis description
    The mixed logistic regression model was adjusted for age, baseline BMI and baseline C-reactive protein level.
    Comparison groups
    Colchicine v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.75

    Primary: Change in effort-related signal in the dorsomedial frontal cortex

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    End point title
    		 Change in effort-related signal in the dorsomedial frontal cortex
    End point description
    Effort-related signal in the dorsomedial frontal cortex was measured during a food-related effort-based decision making task using functional MRI.
    End point type
    Primary
    End point timeframe
    Follow-up (at 12 weeks) - Baseline
    End point values
    		 Colchicine Placebo
    Number of subjects analysed
    24
    25
    Units: a.u.
    arithmetic mean (standard deviation)
        Baseline
    0.38 ( 0.61 )
    0.17 ( 0.65 )
        Follow-up
    0.19 ( 0.65 )
    0.49 ( 0.68 )
    Statistical analysis title
    		 Mixed regression model: Change in ROI signal
    Statistical analysis description
    The mixed linear regression model was adjusted for age, baseline BMI and baseline C-reactive protein level.
    Comparison groups
    Colchicine v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from the First Patient First Visit (FPFV) until the Last Patient Last Visit (LPLV).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Colchicine
    Reporting group description
    		 Participants received one capsule of colchicine 0.5mg daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received one placebo capsule daily.

    Serious adverse events
    		 Colchicine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Colchicine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 31 (90.32%)
    28 / 33 (84.85%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Schwannoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 31 (51.61%)
    15 / 33 (45.45%)
         occurrences all number
    33
    24
    Neuropathy peripheral
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 31 (6.45%)
    6 / 33 (18.18%)
         occurrences all number
    2
    8
    Hot flush
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Bruising tendency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Immune system disorders
    Insect bite hypersensitivity
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Gastrointestinal disorder NOS (Not Otherwise Specified)
         subjects affected / exposed
    13 / 31 (41.94%)
    17 / 33 (51.52%)
         occurrences all number
    17
    22
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    5 / 31 (16.13%)
    2 / 33 (6.06%)
         occurrences all number
    7
    3
    Uterine polyp
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 31 (35.48%)
    7 / 33 (21.21%)
         occurrences all number
    19
    10
    Bursitis infective
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 31 (32.26%)
    20 / 33 (60.61%)
         occurrences all number
    11
    26
    Pneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Periodontitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2022
    Changes to the in- and exclusion criteria, most notably an extension of the age range from 18–55 to 18–59 years and the exclusion of participants who had undergone bariatric surgery within the past 5 years.
    12 Oct 2022
    Addition of an external partner for the execution of the study.
    01 Mar 2023
    Changes to the inclusion and exclusion criteria related to inflammation and BMI, including modification of the CRP threshold from a fixed range of 3–10 mg/L for all participants to a BMI-dependent range (3–22.1 mg/L for participants with BMI >31 kg/m² and 3–10 mg/L for BMI <31 kg/m²), and an adjustment of the BMI inclusion criterion from >27 kg/m² to >30 kg/m².
    13 Sep 2023
    Changes in the recruitment strategy, compensation costs, and inclusion criteria (inclusion of left-handed participants).
    27 Mar 2024
    Changes in the recruitment and inclusion strategy.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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