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

Dr. Schär

Status

Enrolling

Conditions

Chronic Kidney Disease stage4

Chronic Kidney Disease Stage 3B

Chronic Kidney Disease Stage 5

Treatments

Other: Consumption of FLAVIS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05489120

EFFLAVIS

Details and patient eligibility

About

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.

Enrollment

244 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.