Oral Citrulline Supplementation in COPD Patients With Malnutrition
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Grenoble
About this trial
Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.
The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 50 and over
COPD stage 3 or 4 according to GOLD criteria
BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old
Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire
Disqualifiers
Main respiratory disease other than COPD
Daily long-term use of systemic corticosteroids (>6 months per year, whatever the dose)
Severe and end-stage renal insufficiency (creatinine clearance <30ml/min)
Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)
Trial design
Design model
Parallel
Treatments tested in this trial
L-citrulline
Drugto take 1 pod a day for 45 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CitrullineExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fat Free Mass Index
Fat Free Mass Index (in kg.m-2) measured by bioelectrical impedance analysis
Time frame
baseline, 45+/-5 day and 1 year +/- 2 weeksSecondary outcomes
1
Grip strength
Grip strength will be measured using a dynamometer with the patient in a seated position, elbow bent at 90°, shoulders relaxed and forearm in a neutral position. The dynamometer should be held in the dominant hand. The measurement should be taken twice. The highest value will be used.
Time frame
baseline, 45+/-5 day and 1 year +/- 2 weeks2
Maximum quadriceps strength
The maximum voluntary force of the quadriceps of the left lower limb will be measured on a weight bench using a strain gauge to determine force during isometric contraction (at 90° knee flexion). The position of the patient will be standardized: arms crossed over the chest, no back support during the measurement and no support of the hips and contralateral leg to avoid any compensatory movement. Three reproducible measurements (+/-10%) will be taken at 1 min intervals, with the highest value selected.
Time frame
baseline, 45+/-5 day and 1 year +/- 2 weeks3
6-minute walk test
The 6-min walking test (6MWT) measures the distance that a patient can walk on an indoor 30-m flat corridor for a 6-min period. Due to a familiarisation effect, two tests will be performed, with at least 15 min of intervening rest, with the greatest distance in the two tests being recorded. The 6-min walking distance (6MWD) will be expressed in metres. Other variables will be measured: minimum pulse oxygen saturation (SpO2), peak heart rate and dyspnoea and fatigue ratings at the end of test.
Time frame
baseline, 45+/-5 day and 1 year +/- 2 weeks4
Quality of life questionnaires
Time frame
baseline, 45+/-5 day and 1 year +/- 2 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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