Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Recruiting now · Not applicable
Conditions studied: Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 3A
In brief
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.
Key facts
- Study ID
- NCT05489120
- Run by
- Dr. Schär AG / SPA
- People needed
- 244
- Starts
- 2022-11-06
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Clinique sainte isabelle — Abbeville, France (enrolling)
- Hospices Civiles de Lyon — Lyon, France (enrolling)
- Saint Joseph Saint Luc — Lyon, France (enrolling)
- Hôpital la conception — Marseille, France (enrolling)
- CH Mâcon — Mâcon, France (enrolling)
- Hôpital Drôme Nord — Romans-sur-Isère, France (enrolling)
- Calydial — Vienne, France (enrolling)
- Hôpital Nord-Ouest — Villefranche-sur-Saône, France (enrolling)
- CHU Besançon — Besançon, France (enrolling)
- Maison du Rein — Bordeaux, France (enrolling)
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (enrolling)
- CH Chalon — Chalon-sur-Saône, France (enrolling)
- CHU Gabriel Montpied — Clermont-Ferrand, France (enrolling)
- CH Le Mans — Le Mans, France (enrolling)
- Cabinet médical du Dr Magnant — Aix-en-Provence, France
- Nouvel Hôpital Civil — Strasbourg, France
- APHP - Hôpital Necker — Paris, France
- Hôpital Edouard Heriot — Lyon, France
- AURA Paris — Paris, France
- Tenon hospital -APHP — Paris, France
- Santélys BFC — Dijon, France
Full record on ClinicalTrials.gov
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