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

Enteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968836
• Other study ID #: 15.04.CLI
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Dietary Supplement:
• Blend of amino acids
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
• Maltodextrin only
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré (AP-HP)	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)