NCT02968836

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Enteral Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Blend of amino acids	The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
DIETARY_SUPPLEMENT	Maltodextrin only	The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-09-30
• Completion: 2019-12-31
• First posted: 2016-11-21
• Last updated: 2022-05-02

Locations

1 site across 1 country: France