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NCT05514184: PLAFOND

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

ENROLLING BY INVITATION NA Last updated 3 July 2024
What this trial tests

NA trial testing PLAFOND diet in Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM) in 120 participants. Enrolling by invitation.

Timeline
1 October 2023
Primary endpoint
30 March 2026
30 September 2026

Quick facts

Lead sponsorUniversity of California, Irvine
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment120
Start date1 October 2023
Primary completion30 March 2026
Estimated completion30 September 2026
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Irvine

Who can join

18 and older, any sex, with Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM) or CKD Stage 3. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Emerging Preventive Strategies in Chronic Kidney Disease: Recent Evidence and Gaps in Knowledge.
    Pradhan N, Dobre M. · · 2023 · cited 7× · PMID 38038822 · DOI 10.1007/s11883-023-01172-5

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