Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition

tbp

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.

2024-01-25

2026-01-25

2026-09-25

Not yet recruiting

Early phase I

60

Inclusion Criteria: * 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 * Absence of severe COPD exacerbation for at least 3 months Exclusion Criteria: * 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) * Contraindication to L-citrulline intake: VKA and/or cancer chemotherapy * Osmotic diarrhoea * Severe and/or uncontrolled progressive pathology likely to be life-threatening * Psychiatric pathology (schizophrenia, dementia, severe bipolar/psychotic disorders, severe depressive syndrome) * Pacemaker or other implanted electronic device

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2024-01-19