Comparing low-protein diets with and without special low-protein foods for patients with chronic kidney disease
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
This study is testing if a low-protein diet that includes special low-protein foods can help people with chronic kidney disease stick to their diet better and feel healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dr. Schär AG / SPA Industry-sponsored |
| Locations | 21 sites (Abbeville and 20 other locations) |
| Trial ID | NCT05489120 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a low-protein diet (LPD) that includes specially developed low-protein foods (FLAVIS) versus a standard low-protein diet without these foods in patients with chronic kidney disease (CKD) stages 3A to 5. The goal is to determine if the inclusion of FLAVIS can help patients meet their nutritional goals and improve adherence to dietary recommendations. Participants will be monitored for their ability to follow the diet and achieve desired protein intake levels. The study aims to provide insights into dietary management for CKD patients to enhance their quality of life.
Who should consider this trial
Good fit: Ideal candidates are CKD patients in stages 3A to 5 who are not on dialysis and are motivated to adopt a low-protein diet.
Not a fit: Patients who are expected to start dialysis or transplantation within the next 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve dietary compliance and overall health outcomes for patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with low-protein diets in CKD management, but the specific use of FLAVIS foods is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Abbeville and 20 other locations
- Clinique sainte isabelle — Abbeville, France (Recruiting)
- Cabinet médical du Dr Magnant — Aix-en-Provence, France (Completed)
- CHU Besançon — Besançon, France (Recruiting)
- Maison du Rein — Bordeaux, France (Recruiting)
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
- CH Chalon — Chalon-sur-Saône, France (Recruiting)
- CHU Gabriel Montpied — Clermont-Ferrand, France (Recruiting)
- Santélys BFC — Dijon, France (Withdrawn)
- CH Le Mans — Le Mans, France (Recruiting)
- Hospices Civiles de Lyon — Lyon, France (Recruiting)
- Hôpital Edouard Heriot — Lyon, France (Withdrawn)
- Saint Joseph Saint Luc — Lyon, France (Recruiting)
- Hôpital la conception — Marseille, France (Recruiting)
- CH Mâcon — Mâcon, France (Recruiting)
- APHP - Hôpital Necker — Paris, France (Not_yet_recruiting)
- AURA Paris — Paris, France (Withdrawn)
- Tenon hospital -APHP — Paris, France (Terminated)
- Hôpital Drôme Nord — Romans-sur-Isère, France (Recruiting)
- Nouvel Hôpital Civil — Strasbourg, France (Not_yet_recruiting)
- Calydial — Vienne, France (Recruiting)
- Hôpital Nord-Ouest — Villefranche-sur-Saône, France (Recruiting)
Study contacts
- Study coordinator: Vinciane Dumay
- Email: v.dumay@slbpharma.com
- Phone: 0756917356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.