PLADO for Conservative Management of CKD
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
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
Treatments tested in this trial
- PLADO
- Standard-of-care diet
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lebanese American University
Lead sponsor
Zayed University
Collaborator
Maastricht University
Collaborator
Source ClinicalTrials.gov