An interventional study of Blend of amino acids and Maltodextrin only in Enteral Nutrition, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Supportive care
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.
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.
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blend of amino acids
Dietary Supplement: Blend of amino acids
maltodextrin only
Dietary Supplement: Maltodextrin only
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
Safety: Renal function change
Renal function will be daily assessed from urine output, serum creatinin and glomerular filtration rate
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Over 60 days from the beginning of intervention (timepoints: D1, D7, D14, D21, D60)
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Société des Produits Nestlé (SPN)