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

Chronic Kidney Disease Stage 5 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489120
• Other study ID #: EFFLAVIS
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: September 15, 2025

Study information

• Verified date: September 2023
• Source: Dr. Schär AG / SPA
• Contact: Charlotte Cameli
• Phone: 0299121962
• Email: c.cameli[@]slbpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CKD patient stage 3b-5 (<45 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),

• Diabetis mellitus (Type I and 2 defined as fasted glycemia > 1 .26 g/L or HbA1C >7% or anti-diabetic treatment),

• Active cancer,

• Psychiatric disorders or inability to follow the protocol,

• Evidence of any active infectious or 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,

• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3B
• Chronic Kidney Disease Stage 5
• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
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	Hospices Civiles de Lyon	Lyon
France	CH Mâcon	Mâcon
France	Hôpital la conception	Marseille
France	AURA Paris	Paris
France	Tenon hospital -APHP	Paris
France	Hôpital Nord-Ouest	Villefranche-sur-Saône

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Schär AG / SPA	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 month
Secondary	Protein intake during the 12 months follow-up	Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25	1 month, 3 month, 6 month and 9 month
Secondary	Dietary adherence	3-day dietary record correlated to a 24-hour urine collection	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Dietary compliance for products under study	quantities consumed of FLAVIS products.	monthly up to 12 months
Secondary	Effects of the LPD on BMI	weight and height will be combined to report BMI in kg/m^2	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Effects of the LPD on weight	Weight in kg	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Effects of the LPD on body composition: water	Water in litres	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Effects of the LPD on body composition: muscles	Muscles in Kg	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Effects of the LPD on body composition: body protein content	Body protein content in Kg	baseline, 1 month, 3 month, 6 month and 12 month
Secondary	Effects of the LPD on Blood	Blood Chemistry	baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Secondary	Effects of the LPD on Urine	Urine Chemistry	baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Secondary	Incidence of Adverse Events [Safety of the LPD]	Questioning and a clinical examination; 4-point Likert scale.	3 month, 6 month and 12 month
Secondary	Patient quality of life	SF-36 questionnaire score which from 0 to 100	baseline, 3 month, 6 month and 12 month
Secondary	Patient satisfaction with LPD	Auto-questionnaire, open questions	3 month, 6 month and 12 month