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

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

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.

Inclusion Criteria:

• CKD patient stage 3a-5 (<60 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),
• Uncontrolled Diabetes (HbA1C >8.5%),
• Active cancer (including a 5 years remission period),
• Psychiatric disorders or inability to follow the protocol,
• Evidence of any active infectious or uncontrolled 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,
• Patient with an active implanted medical device
• 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.