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ENROLLING BY INVITATION
NCT05514184
NA

Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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