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Not yet recruiting NCT06212765

Oral Citrulline Supplementation in COPD Patients With Malnutrition

Phase III Interventional Chronic Obstructive Pulmonary Disease Severe Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: L-citrulline.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease Severe, Malnutrition. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug L-citrulline
    to take 1 pod a day for 45 days

Primary outcome measures

  • Fat Free Mass Index [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
Secondary outcome measures (11)
  • Grip strength [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • Maximum quadriceps strength [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • 6-minute walk test [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • Quality of life questionnaires [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • Number of steps walked daily measured by actigraphy [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • Flow-mediated dilation [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • BODE index [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • COPD Assessment Test (CAT) [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • Visual Simplified Respiratory Questionnaire (VSRQ) [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • mMRC dyspnea scale [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]
  • DIsability RElated to COPD Tool (DIRECT) [Time frame: baseline, 45+/-5 day and 1 year +/- 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06212765 · tbp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗