Oral Citrulline Supplementation in COPD Patients With Malnutrition

NCT06212765 | Not Yet Recruiting Phase 3

• 1 other identifier: tbp
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

COPD; L-citrulline; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Fat Free Mass Index

  Fat Free Mass Index (in kg.m-2) measured by bioelectrical impedance analysis

  baseline, 45+/-5 day and 1 year +/- 2 weeks

Secondary Outcomes (11)

• Grip strength

  baseline, 45+/-5 day and 1 year +/- 2 weeks

• Maximum quadriceps strength

  baseline, 45+/-5 day and 1 year +/- 2 weeks

• 6-minute walk test

  baseline, 45+/-5 day and 1 year +/- 2 weeks

• Quality of life questionnaires

  baseline, 45+/-5 day and 1 year +/- 2 weeks

• Number of steps walked daily measured by actigraphy

  baseline, 45+/-5 day and 1 year +/- 2 weeks

Study Arms (2)

Citrulline

EXPERIMENTAL

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.

Drug: L-citrulline

Standard care

ACTIVE COMPARATOR

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.

Drug: L-citrulline

Interventions

L-citrulline DRUG

to take 1 pod a day for 45 days

Citrulline; Standard care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Malnutrition; Pulmonary Disease, Chronic Obstructive

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Bruno Degano, MD, PhD

CONTACT

0033476766400; bdegano@chu-grenoble.fr

Samarmar Chacaroun, PhD

CONTACT

schacaroun@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 19, 2024
• Study Start: January 25, 2024
• Primary Completion: January 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: January 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: when all the data has been analysed and published