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

Launched by DR. SCHÄR AG / SPA · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a low-protein diet on patients with chronic kidney disease (CKD) stages 3B to 5. The goal is to see if using specially designed low-protein foods, like FLAVIS®, can help patients better manage their protein intake and improve their health. A low-protein diet is recommended for CKD patients to help reduce the risk of serious kidney problems and enhance their quality of life.

To participate in the trial, patients need to be between 65 and 74 years old, have CKD stages 3B to 5 (but not on dialysis), and have good nutritional status. They should be motivated to change their dietary habits and willing to attend regular check-ups. Participants will receive guidance on following the low-protein diet and will be asked to keep track of their food intake. It's important to note that patients with certain conditions, like diabetes or active cancer, or those expecting to start dialysis soon, will not be eligible to join the study.

Gender

ALL

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.