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PLADO for Conservative Management of CKD

ConditionsChronic Kidney Disease(CKD)Metabolic Acidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLebanese American University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PLADO

    Other intervention

    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

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: PLADOExperimental treatment 1 intervention
Group B: Standard-of-care dietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Metabolic acidosis assessed by PTCO2

Time frame
Baseline, Monthly for 6 months, Month 9

Secondary outcomes

1

Body weight

Body weight measured using a balance beam scale Unit: kg

Time frame
Baseline, Months 3, 6, and 9
2

%Weight Change

%Weight Change (to the last measurement) Unit: %

Time frame
Months 3, 6, and 9
3

Triceps Skinfold thickness

Triceps Skinfold thickness measured using a measuring tape and a skinfold caliper Unit: mm

Time frame
Baseline, Months 3, 6, and 9
4

Body Fat Percentage

%Body Fat for edema-free patients assessed using Bioimpedance analysis (Maltron Bioscan) Unit: %

Time frame
Baseline, Months 3, 6, and 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lebanese American University

Lead sponsor

Zayed University

Collaborator

Maastricht University

Collaborator

Source ClinicalTrials.gov
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