Clinical trial NCT06212765: Oral Citrulline Supplementation in COPD Patients With Malnutrition
Official title: Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease Severe
Malnutrition
Keywords: COPD
L-citrulline
Malnutrition
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Fat Free Mass Index
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: Maximum quadriceps strength
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: 6-minute walk test
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: Quality of life questionnaires
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: Number of steps walked daily measured by actigraphy
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: Flow-mediated dilation
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: BODE index
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: COPD Assessment Test (CAT)
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: Visual Simplified Respiratory Questionnaire (VSRQ)
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: mMRC dyspnea scale
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
measure: DIsability RElated to COPD Tool (DIRECT)
timeFrame: baseline, 45+/-5 day and 1 year +/- 2 weeks
Other outcomes:
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