Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)

Study Overview
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Brief Summary
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The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

Official Title
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Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

Conditions
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Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5

Intervention / Treatment
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* Other: Consumption of FLAVIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD patient stage 3b-5 (<45 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis, With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition), Above 1g protein/ kg bw (ideal body weight), LPD-naïve patient, Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up), Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires), Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France), Having given their informed written consent regarding its participation to the protocol. Exclusion Criteria: Patient for whom dialysis or transplantation is planned/expected within the next 12 months Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut), Diabetis mellitus (Type I and 2 defined as fasted glycemia > 1 .26 g/L or HbA1C >7% or anti-diabetic treatment), Active cancer, Psychiatric disorders or inability to follow the protocol, Evidence of any active infectious or inflammatory diseases, Inability to provide blood samples (poor venous capital), Inability to perform correct 24-hours urine collection, Any change of the chronic medication within 1 month before screening, Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator, Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial. Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: COMPARATOR<br>Follow-up of the CKD patient according to current practice i.e. low protein diet. | |
| Experimental: FLAVIS<br>Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS). | Other: Consumption of FLAVIS<br>* Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) | Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25 | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein intake during the 12 months follow-up | Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25 | 1 month, 3 month, 6 month and 9 month | 
| Dietary adherence | 3-day dietary record correlated to a 24-hour urine collection | baseline, 1 month, 3 month, 6 month and 12 month | 
| Dietary compliance for products under study | quantities consumed of FLAVIS products. | monthly up to 12 months | 
| Effects of the LPD on BMI | weight and height will be combined to report BMI in kg/m^2 | baseline, 1 month, 3 month, 6 month and 12 month | 
| Effects of the LPD on weight | Weight in kg | baseline, 1 month, 3 month, 6 month and 12 month | 
| Effects of the LPD on body composition: water | Water in litres | baseline, 1 month, 3 month, 6 month and 12 month | 
| Effects of the LPD on body composition: muscles | Muscles in Kg | baseline, 1 month, 3 month, 6 month and 12 month | 
| Effects of the LPD on body composition: body protein content | Body protein content in Kg | baseline, 1 month, 3 month, 6 month and 12 month | 
| Effects of the LPD on Blood | Blood Chemistry | baseline, 1 month, 3 month, 6 month, 9 month and 12 month | 
| Effects of the LPD on Urine | Urine Chemistry | baseline, 1 month, 3 month, 6 month, 9 month and 12 month | 
| Incidence of Adverse Events [Safety of the LPD] | Questioning and a clinical examination; 4-point Likert scale. | 3 month, 6 month and 12 month | 
| Patient quality of life | SF-36 questionnaire score which from 0 to 100 | baseline, 3 month, 6 month and 12 month | 
| Patient satisfaction with LPD | Auto-questionnaire, open questions | 3 month, 6 month and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety