Plant-Focused Diet for Diabetes and Chronic Kidney Disease
(PLAFOND Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byConnie M Rhee, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kamyar Kalantar-Zadeh, MD, MPH, PhD

Principal Investigator

University of California

Connie M Rhee, MD, MS

Principal Investigator

University of California

Eligibility Criteria

This trial is for adults over 18 with diabetes and chronic kidney disease stages 3-5 who want to avoid or delay dialysis. Participants must have had two eGFRs <60 ml/min/1.73m2 three months apart, follow dietary instructions, and attend baseline and follow-up visits.

Inclusion Criteria

I agree to follow the diet plan and attend all required visits or calls.

I am an adult with diabetes and kidney disease stage 3-5, wanting to avoid dialysis.

Treatment Details

Interventions

PLAFOND diet (Dietary Supplement)

Trial OverviewThe PLAFOND diet, which is mostly plant-based, will be tested against the standard low-potassium, low-salt CKD diet in patients with diabetes and chronic kidney disease. The study aims to check if this new diet can be followed safely without causing malnutrition or worsening health markers.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Plant-focused low-protein nutrition in diabetic CKD (PLAFOND)Experimental Treatment1 Intervention

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.

Group II: Standard-of-care renal diet (control group)Active Control1 Intervention

Participants randomized to the control group will receive standard-of-care renal diet with low-potassium content based on dietitian counseling and guidance.