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

Not Applicable

Completed

• Conditions: Enteral Nutrition
• Interventions: Dietary Supplement: Blend of amino acids; Dietary Supplement: Maltodextrin only

• Registration Number: NCT02968836
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

This monocentric trial was a parallel, randomized, double-blind, controlled study. Patients hospitalized in the ICU for sepsis or ARDS were enrolled.

The treatment group (n=15) was administered the study product (amino acid blend) and the negative control group (=15) was administrated maltodextrin only. The mode of administration was nasogastric probe.

The treatment period was 21 days. Subject were followed during stay in High care and intermediate care units up to 2 months or after hospital discharge with a follow up until 12 months.

Recruitment stopped when 30 patients (15 in each group) reached V4.

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-21
• Study Start: 2017-06-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	Blend of amino acids	Blend of amino acids
Placebo group	Maltodextrin only	maltodextrin only

Primary Outcome Measures

Name	Time	Method
Efficacy: gut barrier structure and functionality improvement	12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)	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
Efficacy: general recovery improvement	12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)	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
Safety: Renal function change	60 days from the beginning of the intervention	Renal function will be daily assessed from urine output, serum creatinin and glomerular filtration rate
Efficacy: inflammatory status change	12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)	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)
Nutrient profiling	Over 60 days from the beginning of intervention (timepoints: D1, D7, D14, D21, D60)	Nutrient profiling will be assessed from blood metabolomics analyses
Efficacy: muscle functionality change	12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)	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).

Trial Locations

Locations (1)

Hôpital Raymond Poincaré (AP-HP); 🇫🇷 Garches, France