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Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease
Sponsor: University of California, Irvine
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-10-01
Completion Date
2026-09-30
Last Updated
2024-07-03
Healthy Volunteers
No
Conditions
Interventions
PLAFOND diet
PLAFOND is a pragmatic patient-centered dietary intervention supported by dietitians who provide education and counseling in the form of Medical Nutrition Therapy (MNT) consisting of 0.6-0.8 g/kg/day dietary protein with \>2/3% of the protein from plant-proteins.
Locations (2)
UCI
Orange, California, United States
Harbor-UCLA/Lundquist
Torrance, California, United States