Plant-dominant low-protein diet versus standard care in adults with chronic kidney disease stages 3-5: A randomized controlled trial protocol.
Joelle Abi Kharma, Rana Sultan, Rana Rizk...
https://pubmed.ncbi.nlm.nih.gov/42155424Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06932042
Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial
Led by Lebanese American University · Updated on 2025-04-17
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lebanese American University
Lead Sponsor
Z
Zayed University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is focused on adults with chronic kidney disease (CKD) to evaluate if a plant-dominant low protein diet (PLADO) can reduce metabolic acidosis, a key factor in CKD progression. Researchers aim to determine whether the PLADO diet is more effective than the standard-of-care CKD diet and to assess its safety, practicality, and cost-effectiveness. The trial is a randomized controlled study led by Lebanese American University.
CONDITIONS
Brief Title
PLADO for Conservative Management of CKD
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and above
- Diagnosed with stages 3-5 chronic kidney disease with estimated GFR ≤59 ml/min/1.73 m2 stable for at least three months
- Controlled glycemic and blood pressure parameters on treatment
- Normal nutritional status according to GLIM criteria
- Willing to undergo baseline screening and attend monthly face-to-face visits at the outpatient department
You will not qualify if you...
- Presence of overt infection, persistent anorexia, vomiting, or diarrhea within the last month
- Wasting diseases such as cancer, tuberculosis, liver failure, or heart failure
- Serum potassium levels greater than 5.5 mEq/L during the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months with an additional 3 months follow-up
Participants receive either a low protein plant-dominant diet (PLADO) or the standard-of-care diet. The nutrition education intervention includes a primary face-to-face education/counseling session followed by monthly face-to-face follow-up sessions for 6 months, and an additional follow-up session after 3 months. At each visit, participants are assessed and receive stage-based education and counseling to support adherence.
1 baseline visit and monthly visits for 6 months, plus 1 visit after 3 months
Trial Site Locations
Total: 1 location
1
Lebanese American University Medical Center- Rizk Hospital
Beirut, Lebanon
Actively Recruiting
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Research Team
R
Rana Rizk, PhD, MS, MPH, LD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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