PLADO for Conservative Management of CKD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PLADO, Standard-of-care diet.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease(CKD), Metabolic Acidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial
Overview
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.
Interventions
- Other 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 - Other 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.
Primary outcome measures
- Metabolic acidosis assessed by PTCO2 [Time frame: Baseline, Monthly for 6 months, Month 9]
Secondary outcome measures (12)
- Body weight [Time frame: Baseline, Months 3, 6, and 9]
- %Weight Change [Time frame: Months 3, 6, and 9]
- Triceps Skinfold thickness [Time frame: Baseline, Months 3, 6, and 9]
- Body Fat Percentage [Time frame: Baseline, Months 3, 6, and 9]
- Fat Free Mass Percentage [Time frame: Baseline, Months 3, 6, and 9]
- Total Body Water Percentage [Time frame: Baseline, Months 3, 6, and 9]
- Blood Urea Nitrogen (BUN) [Time frame: Baseline, Monthly for 6 months, Month 9]
- Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline, Monthly for 6 months, Month 9]
- Serum Potassium (K) [Time frame: Baseline, Monthly for 6 months, Month 9]
- Serum Phosphorus (P) [Time frame: Baseline, Monthly for 6 months, Month 9]
- C-Reactive Protein (CRP) [Time frame: Baseline, Months 3, 6, and 9]
- Albumin [Time frame: Baseline, Months 3, 6, and 9]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Lebanon · 1 center
- Lebanese American University Medical Center- Rizk Hospital — Beirut
Publications
- 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
Identifiers
NCT: NCT06932042 · LAU.SAS.RR4.2/Feb/2024