Clinical trial NCT06932042: PLADO for Conservative Management of CKD
Official title: Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Metabolic Acidosis
Keywords: Chronic kidney disease
metabolic acidosis
PLADO
Plant-dominant low protein diet
Nutrition education
Lead sponsor: Lebanese American University
Sponsor class: OTHER
Collaborators: name: Zayed University
name: Maastricht University
First posted: 2025-04-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Metabolic acidosis assessed by PTCO2
timeFrame: Baseline, Monthly for 6 months, Month 9
Secondary outcomes:
measure: Body weight
timeFrame: Baseline, Months 3, 6, and 9
measure: %Weight Change
timeFrame: Months 3, 6, and 9
measure: Triceps Skinfold thickness
timeFrame: Baseline, Months 3, 6, and 9
measure: Body Fat Percentage
timeFrame: Baseline, Months 3, 6, and 9
measure: Fat Free Mass Percentage
timeFrame: Baseline, Months 3, 6, and 9
measure: Total Body Water Percentage
timeFrame: Baseline, Months 3, 6, and 9
measure: Blood Urea Nitrogen (BUN)
timeFrame: Baseline, Monthly for 6 months, Month 9
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Monthly for 6 months, Month 9
measure: Serum Potassium (K)
timeFrame: Baseline, Monthly for 6 months, Month 9
measure: Serum Phosphorus (P)
timeFrame: Baseline, Monthly for 6 months, Month 9
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Months 3, 6, and 9
measure: Albumin
timeFrame: Baseline, Months 3, 6, and 9
measure: Hemoglobin
timeFrame: Baseline, Months 3, 6, and 9
measure: Hematocrit
timeFrame: Baseline, Months 3, 6, and 9
measure: Mean Corpusculum Volume (MCV)
timeFrame: Baseline, Months 3, 6, and 9
measure: Ferritin
timeFrame: Baseline, Months 3, 6, and 9
measure: Glycated hemoglobin A1C
timeFrame: Baseline, Months 3, 6, and 9
measure: Urinary microalbumin: creatinine ratio (UmACR)
timeFrame: Baseline, Months 3, 6, and 9
measure: Urinary potassium excretion
timeFrame: Baseline, Months 3, 6, and 9
measure: Urinary phosphorus excretion
timeFrame: Baseline, Months 3, 6, and 9
measure: Global Leadership Initiative on Malnutrition (GLIM) criteria
timeFrame: Baseline, Months 3, 6, and 9
measure: Total Caloric intake per kilogram body weight (Kcal/kg)
timeFrame: Baseline, Months 3, 6, and 9
measure: Total dietary protein intake per kilogram body weight (g/kg)
timeFrame: Baseline, Months 3, 6, and 9
measure: Carbohydrate intake percentage (%)
timeFrame: Baseline, Months 3, 6, and 9
measure: Total fat intake percentage (%)
timeFrame: Baseline, Months 3, 6, and 9
measure: Trans fat intake percentage (%)
timeFrame: Baseline, Months 3, 6, and 9
measure: Total potassium intake (g)
timeFrame: Baseline, Months 3, 6, and 9
measure: Total phosphorus intake (g)
timeFrame: Baseline, Months 3, 6, and 9
measure: Total sodium intake (g)
timeFrame: Baseline, Months 3, 6, and 9
measure: Nutrition focused physical examination (NFPE)
timeFrame: Baseline, Months 3, 6, and 9
measure: Muscle strength (kg)
timeFrame: Baseline, Months 3, 6, and 9
measure: Gastrointestinal Symptoms
timeFrame: Baseline, Monthly for 6 months, Month 9
measure: Health-related Quality of Life
timeFrame: Baseline, Months 3, 6, and 9
measure: Costs
timeFrame: Baseline, Months 3, 6, and 9
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Lebanese American University Medical Center- Rizk Hospital
Study officials:
References: