Enteral NutritionNCT02968836
Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
A study testing Blend of amino acids and Maltodextrin only in people with Enteral Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- Blend of amino acids and Maltodextrin only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Blend of amino acids, Maltodextrin only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blend of amino acidsDietary supplement
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
Maltodextrin onlyDietary supplement
The product was poured in bottles containing the enteral nutrition that the patient received as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Blend of amino acids Receives: Dietary Supplement: Blend of amino acids |
| Placebo group | Placebo comparator | maltodextrin only Receives: Dietary Supplement: Maltodextrin only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Renal function change
Renal function will be daily assessed from urine output, serum creatinin and glomerular filtration rate
Measured: 60 days from the beginning of the intervention
Efficacy: muscle functionality change
- 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).
Measured: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
Efficacy: gut barrier structure and functionality improvement
- 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
Measured: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
Efficacy: inflammatory status change
- 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)
Measured: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
Efficacy: general recovery improvement
- 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
Measured: 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
Measured: Over 60 days from the beginning of intervention (timepoints: D1, D7, D14, D21, D60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Jun 2017
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Djillali Annane, Pr, Principal investigator, Raymond Poincaré Hospital, Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968836
- Sponsor's protocol ID
- 15.04.CLI
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2016
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.
PubMed 36397118
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
- ClinicalTrials.gov ID
- NCT02968836
- Acronym / sponsor ID
- 15.04.CLI
- Conditions
- Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Dietary Supplement: Blend of amino acidsBlend of amino acids |
| Placebo group | Placebo comparator | Dietary Supplement: Maltodextrin onlymaltodextrin only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blend of amino acidsThe product was poured in bottles containing the enteral nutrition that the patient received as standard of care. | Dietary supplement | Active group |
| Maltodextrin onlyThe product was poured in bottles containing the enteral nutrition that the patient received as standard of care. | Dietary supplement | Placebo group |
Primary outcome
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
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).
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
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 36397118Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djillali Annane, Pr principal investigator
Raymond Poincaré Hospital, Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blend of amino acids and Maltodextrin only in people with Enteral Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Renal function change (time frame: 60 days from the beginning of the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.