Oral Citrulline Supplementation in COPD Patients With Malnutrition

NCT ID: NCT06212765

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2026-09-25

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.

Conditions

Chronic Obstructive Pulmonary Disease Severe; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Citrulline

The experimental product is 100% L-citrulline. Each pod will contain 10 grams of L-citrulline. Ten grams of L-citrulline provide 2.4 g of nitrogen.

Group Type: EXPERIMENTAL

L-citrulline

Intervention Type: DRUG

to take 1 pod a day for 45 days

Standard care

The active comparator is a mixture of the six non-essential amino acids. In order for the active comparator to be iso-nitrogenated compared with the experimental product, it will provide 2.4 g of nitrogen per pod. The active comparator will combine 13.2 % alanine, 19.8 % aspartate, 11.2 % glycine, 17.1 % proline, 15.6 % serine and 23.1 % histidine, for a total of 13 g of amino acids per pod.

Group Type: ACTIVE_COMPARATOR

L-citrulline

Intervention Type: DRUG

to take 1 pod a day for 45 days

Interventions

L-citrulline

to take 1 pod a day for 45 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Bruno Degano, MD, PhD

Role: CONTACT

bdegano@chu-grenoble.fr

0033476766400

Samarmar Chacaroun, PhD

Role: CONTACT

schacaroun@chu-grenoble.fr

Other Identifiers

tbp

Identifier Type: -

Identifier Source: org_study_id