PLADO for Conservative Management of CKD

NCT ID: NCT06932042

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2026-06-30

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.

Conditions

Chronic Kidney Disease(CKD); Metabolic Acidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLADO

Group Type: EXPERIMENTAL

PLADO

Intervention Type: OTHER

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 follow-up session of 30-45 minutes for 6 months, and a face-to-face follow-up session of 30-45 minutes after 3 months. At each visit, participants will be screened according to the Transtheoretical behavior change model (TTM) using a TTM-based algorithm to determine their stage/readiness to adhere to PLADO and will receive stage-based education and counseling accordingly. Stage-based education will be divided into 1) Pre-contemplation and contemplation; 2) Preparation; and 3) Action and Maintenance

Standard-of-care diet

Group Type: ACTIVE_COMPARATOR

Standard-of-care diet

Intervention Type: OTHER

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.

Interventions

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 follow-up session of 30-45 minutes for 6 months, and a face-to-face follow-up session of 30-45 minutes after 3 months. At each visit, participants will be screened according to the Transtheoretical behavior change model (TTM) using a TTM-based algorithm to determine their stage/readiness to adhere to PLADO and will receive stage-based education and counseling accordingly. Stage-based education will be divided into 1) Pre-contemplation and contemplation; 2) Preparation; and 3) Action and Maintenance

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zayed University

OTHER

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: collaborator

Lebanese American University

OTHER

Sponsor Role: lead

Responsible Party

Rana Rizk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lebanese American University Medical Center- Rizk Hospital

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Rana Rizk, PhD, MS, MPH, LD

Role: CONTACT

rana.rizk01@lau.edu.lb

+9611786456 ext. 3741

Facility Contacts

Joelle Abi Kharma

Role: primary

joelle.abikharma@lau.edu.lb

+9611200800 ext. 3806

Other Identifiers

LAU.SAS.RR4.2/Feb/2024

Identifier Type: -

Identifier Source: org_study_id