Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion around
Principal Investigator
by Kamyar Kalantar-Zadeh (uci)

Description

Summary

In this pilot clinical trial, the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease (CKD/DM) stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in Diabetes (PLAFOND) diet with >2/3 plant-based sources, which will be compared with a standard-of-care CKD diet, which is usually a low-potassium and low-salt diet, over a 6-month period. Through this study, the investigators will determine whether the plant-focused diet intervention is feasible for patient adherence, whether this diet is safe by avoiding malnutrition, frailty, and high potassium or glucose blood levels, and whether patient reported outcomes are favorably impacted.

Official Title

Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease (PLAFOND Study): A Pilot/Feasibility Study

Details

Keywords

Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), CKD Stage 3, CKD Stage 4, CKD Stage 5, Diabetes Mellitus, Diabetic Kidney Disease, plant-dominant low protein (PLADO) diet, plant-focused nutrition in CKD/DM (PLAFOND) diet, plant-based protein, glomerular hyperfiltration, high-protein diet, potassium restricted diet, renal disease progression, pilot/feasibility randomized controlled trial, diet adherence, meal plans, renal diet, Veterans, animal protein, continuous glucose monitoring (CGM), CKD-related symptoms, 24-hour urine nitrogen, Cystatin C and associated eGFR, dietary education, Medical Nutrition Therapy (MNT), uremic symptoms, Kidney Diseases, Chronic Renal Insufficiency, Diabetic Nephropathies, PLAFOND diet, Plant-focused low-protein nutrition in diabetic CKD (PLAFOND)

Eligibility

Locations

  • UCI
    Orange California 92868-3217 United States
  • Harbor-UCLA/Lundquist
    Torrance California 90502-2004 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05514184
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated