Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
Conditions
Keywords
low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety
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.
Interventions
OTHERConsumption of FLAVIS
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
Sponsors
Dr. Schär AG / SPA
Slb Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Blood | baseline, 1 month, 3 month, 6 month, 9 month and 12 month | Blood Chemistry |
| 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] | 1 month, 3 month, 6 month, 9 month and 12 month | Questioning and a clinical examination, biological analyses review |
| 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 |
Countries
France
Contacts
STUDY_DIRECTORLaetitia Koppe, Dr
HCL
Outcome results
None listed