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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Consumption of FLAVIS
  Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

Первичные конечные точки

• Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) [Срок оценки: 12 month]

Вторичные конечные точки (12)

• Protein intake during the 12 months follow-up [Срок оценки: 1 month, 3 month, 6 month and 9 month]
• Dietary adherence [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Dietary compliance for products under study [Срок оценки: monthly up to 12 months]
• Effects of the LPD on BMI [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on weight [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: water [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: muscles [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on body composition: body protein content [Срок оценки: baseline, 1 month, 3 month, 6 month and 12 month]
• Effects of the LPD on Blood [Срок оценки: baseline, 1 month, 3 month, 6 month, 9 month and 12 month]
• Effects of the LPD on Urine [Срок оценки: baseline, 1 month, 3 month, 6 month, 9 month and 12 month]
• Effects of the LPD on diabetic patient glycemic profile [Срок оценки: Baseline, 6 month and 12 month]
• Incidence of Adverse Events [Safety of the LPD] [Срок оценки: 1 month, 3 month, 6 month, 9 month and 12 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 21 центр

• Clinique sainte isabelle — Abbeville
• Cabinet médical du Dr Magnant — Aix-en-Provence
• CHU Besançon — Besançon
• Maison du Rein — Bordeaux
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• CH Chalon — Chalon-sur-Saône
• CHU Gabriel Montpied — Clermont-Ferrand
• Santélys BFC — Dijon
• … и ещё 13 центров

Идентификаторы

NCT: NCT05489120 · EFFLAVIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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