Randomized Controlled Trial of a Low-Protein Diet With FLAVIS Low-Protein Foods Versus Standard Low-Protein Diet in Patients With Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating the use of a low-protein diet (LPD) with specially designed low-protein foods called FLAVIS in patients with chronic kidney disease (CKD) stages 3A to 5 who are not on dialysis. The study aims to compare this approach to a standard low-protein diet without these low-protein foods to see if it helps patients better manage their protein intake and potentially improve their quality of life. This trial is randomized and controlled, led by Dr. Schär AG / SPA, following the 2020 KDOQI nutrition guidelines for CKD. Participants are randomly assigned to one of two groups: one will follow a low-protein diet according to current practice, while the other will follow the same diet but with the addition of FLAVIS low-protein products. The intervention group will receive FLAVIS products to include in their diet. The study tracks dietary adherence, protein intake, and other health measures over a 12-month period. During the study, participants will attend scheduled visits at baseline, 1, 3, 6, 9, and 12 months. Researchers will monitor protein intake, diet compliance, body mass index (BMI), weight, body composition, blood and urine markers, diabetic glycemic profiles, patient quality of life, and satisfaction with the diet. Safety will be assessed by tracking adverse events throughout the 12 months. Participants will complete diet records and self-administered questionnaires as part of the data collection process.

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