Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis

Study Overview
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Brief Summary
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The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.

Official Title
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Prospective, Monocentric, Open-label, Randomized Study Comparing Intradialytic Plasma Kinetics of Amino Acids After Administration Per os of Renoral® and Intravenous Administration of Amino Acids.

Conditions
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End Stage Renal Disease on Dialysis (Diagnosis)

Intervention / Treatment
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* Drug: Aminoven 10%
* Dietary Supplement: RENORAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over 18 (limit included), Patients treated with hemodialysis for at least 3 months (limit included), Patient with normal albuminemia ≥ 35 g/L Patient capable and willing to comply with the protocol and willing to give written informed consent, Patient affiliated to a social security scheme. Exclusion Criteria: Patient with a known food allergy or intolerance, Patient with alcohol consumption ≥ 20 g/day (equivalent to 2 glasses per day), Patient following a specific diet (vegetarian, hypocaloric, restrictive gluten-free diet....) outside the high-protein diet of the patient with terminal renal insufficiency or deviant behavior, Pregnant or breastfeeding woman or intending to become pregnant within the next 3 months Patient taking vitamin or mineral supplementation for less than one month, Patient participating in another clinical study or in a period of exclusion from a previous clinical study; Patient refusing to give written consent, Patient not able to read and understand information, consent or other study related documents (self-administered questionnaires), Patient unable to give informed consent, Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Active Comparator: AMINOVEN® 10%<br>The AMINOVEN® 10% comparative product is a drug in the form of a 130 mL intravenous infusion solution. This product is composed of amino acids. The product is administered per os during the first hour of dialysis sessions for the duration of the study. | Drug: Aminoven 10%<br>* After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: group A: RENORAL® product group B: AMINOVEN® 10% product group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month (Day 90, Day 120, Day 150). Protocol visits are included in the patient's course of care.<br>|
| Experimental: RENORAL®<br>The product under study RENORAL® is notified to the DGCCRF with the status of food supplement for medical purposes (FSMP) and specific for renal insufficiency. The product is a beverage packaged in 150 mL aluminum cans. It contains a liquid solution of native milk proteins and partially hydrolyzed whey proteins. | Dietary Supplement: RENORAL<br>* After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: group A: RENORAL® product group B: AMINOVEN® 10% product group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month ( V3, V4, V5). Protocol visits are included in the patient's course of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma total amino acid concentration | The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups. | Day 60; Time 240 minutes of the kinetic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma total amino acid concentration | Comparison between the RENORAL® group and the plasma total amino acid concentration control group | Day 60; Time 240 minutes of kinetics | 
| Plasma total amino acid concentration | Comparison between the RENORAL® group and each AMINOVEN® group and control | Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics | 
| Plasma total amino acid concentration | Comparison between the RENORAL® group and each AMINOVEN® group and control | Day 90; Day 120 and Day 150 at time 240 minutes of kinetics | 
| Protein catabolism | Plasma urea concentration (mmol.L-1) ; | Day 90; Day 120 and Day 150 at time 0 minutes of kinetics | 
| Protein catabolism | Plasma creatinine concentration (µmol.L-1); | Day 90; Day 120 and Day 150 at time 0 minutes of kinetics | 
| Protein catabolism | Standardized protein catabolism rate (nPCR) (g/kg/day): BUN: Blood urea nitrogen is one of the main renal function parameters (mmol/L). ID Refers to the interdialytic period in hours. ID BUN rise refers to the registered change in blood urea nitrogen during the interdialytic period. The two nPCR formulas used are: nPCR Anuric = 0.22 + (0.864 x (ID BUN rise in mg/dL) / (ID hours)) nPCR Total = nPCR Anuric + (Urine urea nitrogen in g x 150) / (ID hours x Weight in kg) | Day 90; Day 120 and Day 150 at time 0 minutes of kinetics | 
| Inflammation degree | Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1). | Day 90; Day 120 and Day 150 at time 0 minutes of kinetics | 
| Nutritional status | Plasma albumin concentration (g.L-1) ; | Day 90, Day 120 and Day 150; At time 0 minute of kinetics | 
| Nutritional status | - Plasma prealbumin concentration (g.L-1) ; | Day 90, Day 120 and Day 150; At time 0 minute of kinetics | 
| Nutritional status | - Plasma ferritin concentration (µg.L-1) ; | Day 90, Day 120 and Day 150; At time 0 minute of kinetics | 
| Nutritional status | - Plasma transferrin concentration (ng.L-1) ; | Day 90, Day 120 and Day 150; At time 0 minute of kinetics | 
| Nutritional status | - Body mass index (BMI) (kg/m2) | Day 150 | 
| Nutritional status | - Body composition by impedance measurement (Body Composition Monitor / Fresenius Medical Care) analyzed by the following parameters: lean mass (LTM) (kg), fat mass (ATM) (kg) and water overload (OH) (L) | Day 150 | 
| Nutritional status | - Total energy intake (average of the 3 food survey days, kcal/day); | During the week preceding Day 150 | 
| Nutritional status | - Protein consumption (average of the 3 food survey days, g/day) | During the week preceding Day 150 | 
| Muscular force | Evaluated by the gripping force by dynamometry (kg) | Day 150 | 
| Acceptability of Renoral® | Self-administered questionnaire 4 questions: Overall, do you like this product? minimum score:1 (I don't like); maximum score: 9 (I like a lot) How do you find the texture of the product? Score 1: Not at all pleasant Score 2: Somewhat unpleasant Score 3: Somewhat pleasant Score 4: Very pleasant What do you think of the practicality of the product? Score 1 - Not practical at all Score 2 - Not very practical Score 3 - Somewhat practical Score 4 - Very practical What do you think of the vanilla flavour of the product? Score 1 - Much too pronounced Score 2 - Somewhat pronounced Score 3 - Just the right way Score 4 - Not strong enough Score 5 - Really not pronounced | Day 60 and Day 150 |