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

Official title

Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

Overview

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

• Other Consumption of FLAVIS
  Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

Primary outcome measures

• Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) [Time frame: 12 month]

Secondary outcome measures (12)

• Protein intake during the 12 months follow-up [Time frame: 1 month, 3 month, 6 month and 9 month]
• Dietary adherence [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Dietary compliance for products under study [Time frame: monthly up to 12 months]
• Effects of the LPD on BMI [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on weight [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: water [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: muscles [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: body protein content [Time frame: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on Blood [Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month]
• Effects of the LPD on Urine [Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month]
• Effects of the LPD on diabetic patient glycemic profile [Time frame: Baseline, 6 month and 12 month]
• Incidence of Adverse Events [Safety of the LPD] [Time frame: 1 month, 3 month, 6 month, 9 month and 12 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 21 centers

• Clinique sainte isabelle — Abbeville
• Cabinet médical du Dr Magnant — Aix-en-Provence
• CHU Besançon — Besançon
• Maison du Rein — Bordeaux
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• CH Chalon — Chalon-sur-Saône
• CHU Gabriel Montpied — Clermont-Ferrand
• Santélys BFC — Dijon
• … and 13 more centers

Identifiers

NCT: NCT05489120 · EFFLAVIS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗