Clinical trial NCT05489120: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 3B
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Chronic Kidney Disease Stage 3A
Keywords: low-protein diet
low-protein foods
FLAVIS
compliance
effectiveness
safety
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2022-08-05
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)
timeFrame: 12 month
Secondary outcomes:
measure: Protein intake during the 12 months follow-up
timeFrame: 1 month, 3 month, 6 month and 9 month
measure: Dietary adherence
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Dietary compliance for products under study
timeFrame: monthly up to 12 months
measure: Effects of the LPD on BMI
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Effects of the LPD on weight
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Effects of the LPD on body composition: water
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Effects of the LPD on body composition: muscles
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Effects of the LPD on body composition: body protein content
timeFrame: baseline, 1 month, 3 month, 6 month and 12 month
measure: Effects of the LPD on Blood
timeFrame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
measure: Effects of the LPD on Urine
timeFrame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
measure: Effects of the LPD on diabetic patient glycemic profile
timeFrame: Baseline, 6 month and 12 month
measure: Incidence of Adverse Events [Safety of the LPD]
timeFrame: 1 month, 3 month, 6 month, 9 month and 12 month
measure: Incidence of Adverse Events [Safety of the LPD]
timeFrame: 3 month, 6 month and 12 month
measure: Patient quality of life
timeFrame: baseline, 3 month, 6 month and 12 month
measure: Patient satisfaction with LPD
timeFrame: 3 month, 6 month and 12 month
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Clinique sainte isabelle
city: Aix-en-Provence
country: France
facility: Cabinet médical du Dr Magnant
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: Maison du Rein
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Chalon-sur-Saône
country: France
facility: CH Chalon
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Dijon
country: France
facility: Santélys BFC
city: Le Mans
country: France
facility: CH Le Mans
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Lyon
country: France
facility: Hôpital Edouard Heriot
city: Lyon
country: France
facility: Saint Joseph Saint Luc
city: Marseille
country: France
facility: Hôpital la conception
city: Mâcon
country: France
facility: CH Mâcon
city: Paris
country: France
facility: APHP - Hôpital Necker
city: Paris
country: France
facility: AURA Paris
city: Paris
country: France
facility: Tenon hospital -APHP
city: Romans sur Isère
country: France
facility: Hôpital Drôme Nord
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Vienne
country: France
facility: Calydial
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest
Study officials:
affiliation: HCL
name: Laetitia Koppe, Dr
role: STUDY_DIRECTOR
References: