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

NCT05514184 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
  • CKD Stage 3
  • CKD Stage 4
  • CKD Stage 5
  • Diabetes Mellitus
  • Diabetic Kidney Disease

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.

Sponsors & Collaborators

  • VA Long Beach Healthcare System

    collaborator FED

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Kamyar Kalantar-Zadeh, MD, MPH, PhD · University of California

  • Connie M Rhee, MD, MS · University of California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-03-30
Completion
2026-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514184 on ClinicalTrials.gov