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    Clinical Trial Results:
    Perindopril and Leucine to improve muscle function in older people

    Summary
    EudraCT number
    		 2014-003455-61
    Trial protocol
    		 GB  
    Global end of trial date
    15 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2021
    First version publication date
    29 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2013GR06
    Additional study identifiers
    ISRCTN number
    		 ISRCTN90094835
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    Ninewells Hospital, Dundee, United Kingdom, DD1 9SY
    Public contact
    Professor Miles Witham 0191 208 1317, Tayside Academic Health Sciences Centre Level 10, Ninewells Hospital, Dundee DD1 9SY 01382 383140, +44 01912081317, Miles.Witham@newcastle.ac.uk
    Scientific contact
    Professor Miles Witham 0191 208 1317, Tayside Academic Health Sciences Centre Level 10, Ninewells Hospital, Dundee DD1 9SY 01382 383140, +44 01382 383140, tctu@dundee.ac.uk
    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
    18 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the efficacy of leucine and ACEi in improving physical function in older people with sarcopenia
    Protection of trial subjects
    Monitoring of serum potassium, creatinine, and orthostatic blood pressure (safety for perindopril) Selection of outcomes and study length to minimise burden on participants
    Background therapy
    		 Usual care. Participants undertaking exercise training were excluded as the trial aimed to test the efficacy of perindopril and leucine in participants who were not already exercising. Previous work had already examined the effect of perindopril and leucine as adjuncts to exercise training.
    Evidence for comparator
    		 Placebo selected as this was an efficacy trial and there are no other pharmacological interventions with proven efficacy for sarcopenia.
    Actual start date of recruitment
    01 May 2015
    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
    United Kingdom: 145
    Worldwide total number of subjects
    145
    EEA total number of subjects
    0
    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)
    0
    From 65 to 84 years
    112
    85 years and over
    33

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in UK (14 centres) from June 2018 to December 2020

    Pre-assignment
    Screening details
    		 320 attended screening visit. Screen fail reasons: - Not met sarcopenia criteria: 129 - Symptomatic orthostatic hypotension: 13 - High potassium: 6 - Excluded medication: 4 - Excluded medical condition: 10 - Other: 16

    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, Data analyst, Carer
    Blinding implementation details
    Matching placebo for perindopril and for leucine

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Perindopril + Leucine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perindopril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    2mg once daily, rising to 4mg once daily after 2 weeks if tolerated

    Investigational medicinal product name
    Leucine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    2.5g three times a day with meals

    Arm title
    		 Perindopril placebo + Leucine
    Arm description
    		 -
    Arm type
    		 Mixed placebo/active arm

    Investigational medicinal product name
    Placebo for perindopril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    placebo for 2mg perindopril once daily, changing to placebo for 4mg perindopril once daily after 2 weeks if tolerated

    Investigational medicinal product name
    Leucine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    2.5g three times a day with meals

    Arm title
    		 Perindopril + Leucine placebo
    Arm description
    		 -
    Arm type
    		 Mixed placebo/active arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo/Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for perindopril and placebo for leucine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for 4mg perindopril once daily and placebo for leucine 2.5g three times a day with food

    Number of subjects in period 1
    		Perindopril + Leucine Perindopril placebo + Leucine Perindopril + Leucine placebo Placebo/Placebo
    Started
    39
    33
    34
    39
    Completed
    28
    24
    24
    33
    Not completed
    11
    9
    10
    6
         Adverse event, serious fatal
    -
    -
    1
    -
         Physician decision
    3
    1
    1
    -
         Adverse event, non-fatal
    1
    1
    -
    -
         Other
    2
    1
    -
    -
         Patient choice
    5
    6
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Perindopril + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril placebo + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril + Leucine placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo/Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Perindopril + Leucine Perindopril placebo + Leucine Perindopril + Leucine placebo Placebo/Placebo Total
    Number of subjects
    		 39 33 34 39 145
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 32 29 31 33 125
        85 years and over
    		 7 4 3 6 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 78.1 ± 5.5 78.6 ± 6.5 79.5 ± 6.6 79.0 ± 5.7 -
    Gender categorical
    Units: Subjects
        Female
    		 22 16 17 23 78
        Male
    		 17 17 17 16 67
    Short Physical Performance Battery
    Units: Points
        arithmetic mean (standard deviation)
    		 7.3 ± 2.1 6.7 ± 2.2 6.8 ± 2.5 7.1 ± 2.6 -
    Number of medications
    Units: count
        median (inter-quartile range (Q1-Q3))
    		 4 (2 to 6) 5 (2.5 to 7) 5 (4 to 7) 5 (3 to 7) -
    Subject analysis sets

    Subject analysis set title
    Perindopril vs placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants; comparison of all those receiving perindopril vs all those receiving the placebo for perindopril

    Subject analysis set title
    Leucine vs placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants. Analysis of all those receiving leucine vs all those receiving leucine placebo

    Subject analysis sets values
    		 Perindopril vs placebo Leucine vs placebo
    Number of subjects
    145
    145
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    125
    125
        85 years and over
    20
    20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    78.8 ± 6.0
    78.8 ± 6.0
    Gender categorical
    Units: Subjects
        Female
    78
    78
        Male
    67
    67
    Short Physical Performance Battery
    Units: Points
        arithmetic mean (standard deviation)
    7.0 ± 2.3
    7.0 ± 2.3
    Number of medications
    Units: count
        median (inter-quartile range (Q1-Q3))
    5 (3 to 7)
    5 (3 to 7)

    End points

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    End points reporting groups
    Reporting group title
    Perindopril + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril placebo + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril + Leucine placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo/Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Perindopril vs placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants; comparison of all those receiving perindopril vs all those receiving the placebo for perindopril

    Subject analysis set title
    Leucine vs placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants. Analysis of all those receiving leucine vs all those receiving leucine placebo

    Primary: Short physical performance battery

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    End point title
    		 Short physical performance battery
    End point description
    Repeated measures mixed model adjusted for baseline age, sex, Charlson score, handgrip
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Perindopril vs placebo Leucine vs placebo
    Number of subjects analysed
    145
    145
    Units: points
        arithmetic mean (confidence interval 95%)
    -0.1 (-1.2 to 1.0)
    0.1 (-1.0 to 1.1)
    Statistical analysis title
    		 Repeated measures mixed model
    Comparison groups
    Perindopril vs placebo v Leucine vs placebo
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.89
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference, repeated measures
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1
    Notes
    [1] - Unable to enter results for both comparisons in this 2x2 trial, and the software has incorrectly added the two analysis sets together. The comparison involving perindopril has been reported here, and the number in the analysis is 145 participants.

    Secondary: Six minute walk distance

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    End point title
    		 Six minute walk distance
    End point description
    Repeated measures mixed model adjusted for baseline age, sex, Charlson score, handgrip
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Perindopril vs placebo Leucine vs placebo
    Number of subjects analysed
    145
    145
    Units: metres
        arithmetic mean (confidence interval 95%)
    -32 (-75 to 12)
    17 (-25 to 59)
    No statistical analyses for this end point

    Secondary: Appendicular muscle mass

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    End point title
    		 Appendicular muscle mass
    End point description
    Repeated measures mixed model adjusted for baseline age, sex, Charlson score, handgrip
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Perindopril vs placebo Leucine vs placebo
    Number of subjects analysed
    145
    145
    Units: kg/m2
        arithmetic mean (confidence interval 95%)
    -0.4 (-1.1 to 0.3)
    -0.25 (-0.95 to 0.44)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to 30 days after completion of participation for each individual
    Adverse event reporting additional description
    AEs collected at each study visit and by medical records review
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Perindopril + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril placebo + Leucine
    Reporting group description
    		 -

    Reporting group title
    Perindopril + Leucine placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo/Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Perindopril + Leucine Perindopril placebo + Leucine Perindopril + Leucine placebo Placebo/Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 39 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    Blood and lymphatic system disorders
    leukaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Perindopril + Leucine Perindopril placebo + Leucine Perindopril + Leucine placebo Placebo/Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 39 (97.44%)
    29 / 33 (87.88%)
    31 / 34 (91.18%)
    33 / 39 (84.62%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin cancer
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 39 (15.38%)
    3 / 33 (9.09%)
    3 / 34 (8.82%)
    4 / 39 (10.26%)
         occurrences all number
    6
    3
    3
    4
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Depression
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Muscle strain
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pelvic fracture
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Soft tissue injury
         subjects affected / exposed
    8 / 39 (20.51%)
    3 / 33 (9.09%)
    4 / 34 (11.76%)
    1 / 39 (2.56%)
         occurrences all number
    8
    3
    4
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
    0 / 34 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    2
    1
    0
    2
    Palpitations
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 39 (12.82%)
    2 / 33 (6.06%)
    5 / 34 (14.71%)
    3 / 39 (7.69%)
         occurrences all number
    5
    2
    5
    3
    Headache
         subjects affected / exposed
    5 / 39 (12.82%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    1 / 39 (2.56%)
         occurrences all number
    5
    0
    1
    1
    Lethargy
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Migraine
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
    5 / 34 (14.71%)
    1 / 39 (2.56%)
         occurrences all number
    1
    2
    5
    1
    Diarrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 33 (6.06%)
    3 / 34 (8.82%)
    0 / 39 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Diverticulitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 33 (3.03%)
    2 / 34 (5.88%)
    2 / 39 (5.13%)
         occurrences all number
    3
    1
    2
    2
    Rectal haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vomiting
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    4
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
    1 / 34 (2.94%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    1
    2
    Arthritis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Back pain
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 33 (6.06%)
    1 / 34 (2.94%)
    1 / 39 (2.56%)
         occurrences all number
    2
    2
    1
    1
    Muscle spasms
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 33 (3.03%)
    0 / 34 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    1
    1
    0
    2
    Infections and infestations
    Ear infection
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    2
    Gastroenteritis viral
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Herpes zoster
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    2
    Influenza
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    1 / 39 (2.56%)
         occurrences all number
    3
    0
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 33 (0.00%)
    3 / 34 (8.82%)
    4 / 39 (10.26%)
         occurrences all number
    4
    0
    3
    4
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 33 (9.09%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    3
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    3 / 39 (7.69%)
         occurrences all number
    3
    1
    1
    3
    Urinary tract infection
         subjects affected / exposed
    3 / 39 (7.69%)
    7 / 33 (21.21%)
    4 / 34 (11.76%)
    2 / 39 (5.13%)
         occurrences all number
    3
    7
    4
    2
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    3
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2019
    Changes made over course of trial: - Recruitment extended from 18 months to 30 months - Screening criteria for muscle mass changed (to use Sergi equation and to use cutoffs stratified by BMI) - Removal of pedometer step count as a secondary outcome - Lowering of SARC-F screening threshold from 4 points to 3 points

    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.
    Number of participants recruited (145) is lower than planned recruitment (440) due to slow recruitment. Confidence intervals around outcomes are therefore wider than anticipated and may not exclude minimum clinically important changes

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29301558
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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