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

Qualifiers

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

Treatments tested in this trial

  • L-citrulline

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators