Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients

NCT02968836 | Completed

• 1 other identifier: 15.04.CLI
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality in Intensive Care Unit (ICU) patients. Since this was a proof of concept, exploratory trial, we assessed different primary outcomes without hierarchy.

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (6)

• Safety: Renal function change

  Renal function will be daily assessed from urine output, serum creatinin and glomerular filtration rate

  60 days from the beginning of the intervention

• Efficacy: muscle functionality change

  i. Muscle (quadriceps) extension isometric strength in response to magnetic stimulation; diaphragm muscle strength in response to magnetic stimulation. Forced vital capacity and maximal inspiratory and expiratory pressures will systematically be recorded. ii. Loss in quadriceps muscle mass and metabolism will be measured by Magnetic resonance imaging. Muscle protein catabolism will be evaluated from measures of 3-methyl histidine in the 24-h urine (reported to urine creatinine).

  12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)

• Efficacy: gut barrier structure and functionality improvement

  i. Enterocytes damage by measurement of I-FABP (intestinal fatty acid-binding protein) in plasma and urine. ii. Functional enterocyte mass by citrulline plasma concentration. iii. Gut barrier function by the translocation of bacteria based on plasma D-Lactate concentration

  12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)

• Efficacy: inflammatory status change

  i. Calprotectin in feces, which is secreted by the neutrophils of the gut mucosae and is released in the gut when the mucosa is inflamed. ii. Acute phase protein concentration in plasma (CRP, fibrinogen, ferritin, prealbumin)

  12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)

• Efficacy: general recovery improvement

  i. Length of stay (LOS) in High care and intermediate care units. ii. Time (days) free of ventilation until discharge high care. iii. Time (days) to recover on walking with or without aid

  12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)

• Nutrient profiling

  Nutrient profiling will be assessed from blood metabolomics analyses

  Over 60 days from the beginning of intervention (timepoints: D1, D7, D14, D21, D60)

Study Arms (2)

Active group

ACTIVE COMPARATOR

Blend of amino acids

Dietary Supplement: Blend of amino acids

Placebo group

PLACEBO COMPARATOR

maltodextrin only

Dietary Supplement: Maltodextrin only

Interventions

Blend of amino acids DIETARY_SUPPLEMENT

The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.

Active group

Maltodextrin only DIETARY_SUPPLEMENT

The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 and over
• Sepsis or ARDS patients: expected to stay at least 21 days in ICU (or midcare), to the opinion of the investigator
• Informed consent signed by the patient or/and by his/her representative

You may not qualify if:

• Patient with muscle mass loss due to previous hospitalization
• Intolerance to enteral feeding
• Patients using parenteral feeding
• Chronic renal failure to the opinion of the investigator
• Chronic liver disease to the opinion of the investigator
• Cachectic patients
• Current treatment with paralyzing drugs
• No pacemaker or metal implants interacting with MRI and magnetic stimulation
• Pregnant woman (known)
• Persons without social security
• Under guardianship
• Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
• Patient who is expected not to comply with the study procedures, to the opinion of the investigator

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Hôpital Raymond Poincaré (AP-HP)

Garches, 92380, France

Location

Related Publications (1)

• Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.

  PMID: 36397118 DERIVED

Study Officials

• Djillali Annane, Pr

  Raymond Poincaré Hospital, Garches, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 21, 2016
• Study Start: June 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)