PLADO for Conservative Management of CKD

Официальное название

Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet. The main questions it aims to answer are: * Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD? * Is the PLADO diet safe, viable, and economically attractive adults with CKD? Researchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis. Participants will: * Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months. * Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.

Вмешательства

• Другое PLADO
  Low protein plant-dominant diet (PLADO) of 0.6-0.8 g/kg/day of proteins with at least 50% plant-based sources, sodium of \<4 g/day and \<3 g/day in case of edema or hypertension, fibers of 25-30 g/day, and calories of 30-35 Kcal/kg/day provided in the form of individualized meal plans administered by a licensed/registered dietitian. The nutrition education intervention will be provided via a primary face-to-face education/counseling session of 45-60 minutes, followed by a monthly face-to-face fo
• Другое Standard-of-care diet
  Current standard-of-care diet composed of dietary protein, fluid, sodium potassium, and phosphorus restrictions provided via monthly face-to-face sessions of 30-45 minutes over a period of 6 months, and a follow-up session after 3 months provided by the same licensed/registered dietitian. Patients will be recruited to the control arm in the same period to avoid seasonal differences.

Первичные конечные точки

• Metabolic acidosis assessed by PTCO2 [Срок оценки: Baseline, Monthly for 6 months, Month 9]

Вторичные конечные точки (12)

• Body weight [Срок оценки: Baseline, Months 3, 6, and 9]
• %Weight Change [Срок оценки: Months 3, 6, and 9]
• Triceps Skinfold thickness [Срок оценки: Baseline, Months 3, 6, and 9]
• Body Fat Percentage [Срок оценки: Baseline, Months 3, 6, and 9]
• Fat Free Mass Percentage [Срок оценки: Baseline, Months 3, 6, and 9]
• Total Body Water Percentage [Срок оценки: Baseline, Months 3, 6, and 9]
• Blood Urea Nitrogen (BUN) [Срок оценки: Baseline, Monthly for 6 months, Month 9]
• Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Baseline, Monthly for 6 months, Month 9]
• Serum Potassium (K) [Срок оценки: Baseline, Monthly for 6 months, Month 9]
• Serum Phosphorus (P) [Срок оценки: Baseline, Monthly for 6 months, Month 9]
• C-Reactive Protein (CRP) [Срок оценки: Baseline, Months 3, 6, and 9]
• Albumin [Срок оценки: Baseline, Months 3, 6, and 9]

Критерии участия

Критерии включения

• Patients aged 18 years and above, having controlled glycemic and blood pressure parameters on treatment, with an established diagnosis of stages 3-5 CKD and an estimated GFR ≤59 ml/min/1.73 m2 stable for at least three months, and with a normal nutritional status as defined by the GLIM criteria, attending the CKD outpatient clinics at LAUMC-RH, willing to undergo the baseline screening and attend the monthly face-to-face visits at the outpatient department at LAUMC-RH.

Критерии исключения

• Patients with overt infection, persistent anorexia, vomiting, or diarrhea within the last month, presence of wasting diseases such as cancer, tuberculosis, liver failure, heart failure, and those with serum potassium >5.5 mEq/L during the past 6 months.

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

Лечение

Центры проведения

Ливан · 1 центр

• Lebanese American University Medical Center- Rizk Hospital — Beirut

Публикации

• Kharma JA, Sultan R, Rizk R, Haroun D, Kilani H, Kalantar-Zadeh K, Gubbels J, Bessems K. Plant-dominant low-protein diet versus standard care in adults with chronic kidney disease stages 3-5: A randomized controlled trial protocol. Nutr Res. 2026 Jul;151:1-15. doi: 10.1016/j.nutres.2026.04.004. Epub 2026 Apr 22. PMID 42155424

Идентификаторы

NCT: NCT06932042 · LAU.SAS.RR4.2/Feb/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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