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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
244
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
Clinique sainte isabelle
Abbeville, France
RECRUITINGCabinet médical du Dr Magnant
Aix-en-Provence, France
COMPLETEDCHU Besançon
Besançon, France
RECRUITINGMaison du Rein
Bordeaux, France
RECRUITINGPolyclinique Bordeaux Nord Aquitaine
Bordeaux, France
RECRUITINGCH Chalon
Chalon-sur-Saône, France
RECRUITINGCHU Gabriel Montpied
Clermont-Ferrand, France
RECRUITINGSantélys BFC
Dijon, France
WITHDRAWNCH Le Mans
Le Mans, France
RECRUITINGHospices Civiles de Lyon
Lyon, France
RECRUITING...and 11 more locations
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
Time frame: 12 month
Protein intake during the 12 months follow-up
Maroni formula: (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25
Time frame: 1 month, 3 month, 6 month and 9 month
Dietary adherence
3-day dietary record correlated to a 24-hour urine collection
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study
quantities consumed of FLAVIS products.
Time frame: monthly up to 12 months
Effects of the LPD on BMI
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on weight
Weight in kg
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water
Water in litres
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles
Muscles in Kg
Time frame: 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
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood
Blood Chemistry
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine
Urine Chemistry
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on diabetic patient glycemic profile
Hb1Ac will be measured
Time frame: Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Questioning and a clinical examination, biological analyses review
Time frame: 1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
4-points Likert scale
Time frame: 3 month, 6 month and 12 month
Patient quality of life
SF-36 questionnaire score which from 0 to 100
Time frame: baseline, 3 month, 6 month and 12 month
Patient satisfaction with LPD
Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
Time frame: 3 month, 6 month and 12 month
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