About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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),
Trial design
Parallel
Treatments tested in this trial
Consumption of FLAVIS
Other interventionPatients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Protein intake during the 12 months follow-up
Maroni formula: (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25
Dietary adherence
3-day dietary record correlated to a 24-hour urine collection
Dietary compliance for products under study
quantities consumed of FLAVIS products.
Effects of the LPD on BMI
Weight and height will be combined to report BMI in kg/m\^2.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Schär AG / SPA
Lead sponsor
Slb Pharma
Collaborator