PLADO for Conservative Management of CKD

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

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 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

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.

Sponsors & Collaborators

• Zayed University

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• Lebanese American University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-28

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Lebanon

Study Locations