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Completed

NCT Number: NCT02968836

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

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.

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Key information

Conditions

Enteral Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Raymond Poincaré (AP-HP)

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blend of amino acids

Dietary Supplement

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

Maltodextrin only

Dietary Supplement

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

Primary outcomes

  1. Safety: Renal function change

    Time frame: 60 days from the beginning of the intervention

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

  2. Efficacy: muscle functionality change

    Time frame: 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).

  3. Efficacy: gut barrier structure and functionality improvement

    Time frame: 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

  4. Efficacy: inflammatory status change

    Time frame: 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)

  5. Efficacy: general recovery improvement

    Time frame: 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

  6. Nutrient profiling

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

    Nutrient profiling will be assessed from blood metabolomics analyses

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2016
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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