Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
- Conditions
- End Stage Renal Disease on Dialysis (Diagnosis)
- Interventions
- Dietary Supplement: RENORALDrug: Aminoven 10%
- Registration Number
- NCT03807583
- Lead Sponsor
- Indigo Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RENORAL® RENORAL 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. AMINOVEN® 10% Aminoven 10% 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.
- Primary Outcome Measures
Name Time Method Plasma total amino acid concentration Day 60; Time 240 minutes of the kinetic The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.
- Secondary Outcome Measures
Name Time Method Inflammation degree Day 90; Day 120 and Day 150 at time 0 minutes of kinetics Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).
Protein catabolism Day 90; Day 120 and Day 150 at time 0 minutes of kinetics 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)Plasma total amino acid concentration Day 90; Day 120 and Day 150 at time 240 minutes of kinetics Comparison between the RENORAL® group and each AMINOVEN® group and control
Acceptability of Renoral® Day 60 and Day 150 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 pronouncedNutritional status During the week preceding Day 150 - Protein consumption (average of the 3 food survey days, g/day)
Muscular force Day 150 Evaluated by the gripping force by dynamometry (kg)
Trial Locations
- Locations (1)
Hopital Center
🇫🇷Dunkerque, France