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

Study acronym: PLAFOND
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 3, 2024 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Enrolling by Invitation
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 2v3 Show 1 more changeShow less
    • Study sites: 0 to 2
  3. Primary completion date: Jun 30, 2025 to Mar 30, 2026 Start date: Oct 1, 2022 to Oct 1, 2023 · Completion date: Sep 30, 2025 to Sep 30, 2026v2 Show 2 more changesShow less
    • Start date: Oct 1, 2022 to Oct 1, 2023
    • Completion date: Sep 30, 2025 to Sep 30, 2026
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05514184
Lead Sponsor University of California, Irvine
Collaborators: VA Long Beach Healthcare System
Conditions Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), CKD Stage 3, CKD Stage 4, CKD Stage 5, Diabetes Mellitus, Diabetic Kidney Disease
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov