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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT05514184
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PLAFOND diet — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Jun 2024
Primary completion
Mar 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Plant-focused low-protein nutrition in diabetic CKD (PLAFOND)
    Participants randomized to this arm will receive PLAFOND dietary intervention consisting of a flexible low-protein meal plan including 0.6-0.8 g/kg/day dietary protein with \>2/3% of the protein from plant-based sources, and the meal plan will be supported by dietitian who will provide dietary education and counseling to patients assigned to this arm.
  • Active Comparator: Standard-of-care renal diet (control group)
    Participants randomized to the control group will receive standard-of-care renal diet with low-potassium content based on dietitian counseling and guidance.

Primary Outcome Measure

Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries [ Time Frame: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
UCIOrangeCalifornia92868-3217-
Harbor-UCLA/LundquistTorranceCalifornia90502-2004-

Find similar trials in Orange, CA

By research site
UCI· Orange, CAHarbor-UCLA/Lundquist· Torrance, CA

Related Studies