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

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease Stage 3B; Chronic Kidney Disease Stage4; Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 3A

• Registration Number: NCT05489120
• Lead Sponsor: Dr. Schär AG / SPA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2022-11-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Blood	baseline, 1 month, 3 month, 6 month, 9 month and 12 month	Blood Chemistry
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 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]	3 month, 6 month and 12 month	4-points Likert scale
Patient satisfaction with LPD	3 month, 6 month and 12 month	Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
Patient quality of life	baseline, 3 month, 6 month and 12 month	SF-36 questionnaire score which from 0 to 100

Trial Locations

Locations (21)

Clinique sainte isabelle; 🇫🇷 Abbeville, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Santélys BFC; 🇫🇷 Dijon, France

Hôpital Edouard Heriot; 🇫🇷 Lyon, France

Saint Joseph Saint Luc; 🇫🇷 Lyon, France

APHP - Hôpital Necker; 🇫🇷 Paris, France

Hôpital Drôme Nord; 🇫🇷 Romans sur Isère, France

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

Calydial; 🇫🇷 Vienne, France

Cabinet médical du Dr Magnant; 🇫🇷 Aix-en-Provence, France

Scroll for more (11 remaining)