Low-Protein Diet with Low-Protein Foods Versus a LPD Without LP Foods in Patients with Chronic Kidney Disease (CKD)
- Conditions
- Chronic Kidney Disease Stage 3BChronic Kidney Disease Stage4Chronic Kidney Disease Stage 5Chronic Kidney Disease Stage 3A
- Interventions
- Other: Consumption of FLAVIS
- Registration Number
- NCT05489120
- Lead Sponsor
- Dr. Schär AG / SPA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 244
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLAVIS Consumption of FLAVIS 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).
- Primary Outcome Measures
Name Time Method Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) 12 month Maroni formula : (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25
- Secondary Outcome Measures
Name Time Method Protein intake during the 12 months follow-up 1 month, 3 month, 6 month and 9 month Maroni formula: (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25
Dietary adherence baseline, 1 month, 3 month, 6 month and 12 month 3-day dietary record correlated to a 24-hour urine collection
Dietary compliance for products under study monthly up to 12 months quantities consumed of FLAVIS products.
Effects of the LPD on BMI baseline, 1 month, 3 month, 6 month and 12 month Weight and height will be combined to report BMI in kg/m\^2.
Effects of the LPD on weight baseline, 1 month, 3 month, 6 month and 12 month Weight in kg
Effects of the LPD on body composition: water baseline, 1 month, 3 month, 6 month and 12 month Water in litres
Effects of the LPD on Blood baseline, 1 month, 3 month, 6 month, 9 month and 12 month Blood Chemistry
Effects of the LPD on body composition: muscles baseline, 1 month, 3 month, 6 month and 12 month Muscles in Kg
Effects of the LPD on body composition: body protein content baseline, 1 month, 3 month, 6 month and 12 month Body protein content in Kg
Effects of the LPD on Urine baseline, 1 month, 3 month, 6 month, 9 month and 12 month Urine Chemistry
Effects of the LPD on diabetic patient glycemic profile Baseline, 6 month and 12 month Hb1Ac will be measured
Incidence of Adverse Events [Safety of the LPD] 3 month, 6 month and 12 month 4-points Likert scale
Patient quality of life baseline, 3 month, 6 month and 12 month SF-36 questionnaire score which from 0 to 100
Patient satisfaction with LPD 3 month, 6 month and 12 month Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
Trial Locations
- Locations (21)
Clinique sainte isabelle
🇫🇷Abbeville, France
Santélys BFC
🇫🇷Dijon, France
Hôpital Edouard Heriot
🇫🇷Lyon, France
Tenon hospital -APHP
🇫🇷Paris, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Saint Joseph Saint Luc
🇫🇷Lyon, France
APHP - Hôpital Necker
🇫🇷Paris, France
Hôpital Drôme Nord
🇫🇷Romans sur Isère, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Calydial
🇫🇷Vienne, France
Cabinet médical du Dr Magnant
🇫🇷Aix-en-Provence, France
CHU Besançon
🇫🇷Besançon, France
Maison du Rein
🇫🇷Bordeaux, France
CH Chalon
🇫🇷Chalon-sur-Saône, France
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
CH Le Mans
🇫🇷Le Mans, France
Hôpital la conception
🇫🇷Marseille, France
AURA Paris
🇫🇷Paris, France
Hospices Civiles de Lyon
🇫🇷Lyon, France
CH Mâcon
🇫🇷Mâcon, France
Hôpital Nord-Ouest
🇫🇷Villefranche-sur-Saône, France