PLADO for Conservative Management of CKD

NCT06932042 | Recruiting

• 1 other identifier: LAU.SAS.RR4.2/Feb/2024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic kidney disease; metabolic acidosis; PLADO; Plant-dominant low protein diet; Nutrition education

Outcome Measures

Primary Outcomes (1)

• Metabolic acidosis assessed by PTCO2

  Baseline, Monthly for 6 months, Month 9

Secondary Outcomes (34)

• Body weight

  Baseline, Months 3, 6, and 9

• %Weight Change

  Months 3, 6, and 9

• Triceps Skinfold thickness

  Baseline, Months 3, 6, and 9

• Body Fat Percentage

  Baseline, Months 3, 6, and 9

• Fat Free Mass Percentage

  Baseline, Months 3, 6, and 9

Study Arms (2)

PLADO

EXPERIMENTAL

Other: PLADO

Standard-of-care diet

ACTIVE COMPARATOR

Other: Standard-of-care diet

Interventions

PLADO 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

PLADO

Standard-of-care diet 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.

Standard-of-care diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lebanese American University: lead
• Zayed University: collaborator
• Maastricht University: collaborator

Study Sites (1)

Lebanese American University Medical Center- Rizk Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acidosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rana Rizk, PhD, MS, MPH, LD

CONTACT

+9611786456; rana.rizk01@lau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: May 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)