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

N/A

Waitlist Available

Led By Kamyar Kalantar-Zadeh, MD, MPH, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will involve 120 patients with diabetes and kidney disease who will be randomly assigned to follow a plant-focused diet or a standard kidney disease diet for 6 months. The goal is to see if

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include issues related to maintaining balanced nutrition such as deficiencies or excesses of certain nutrients like potassium or glucose that could impact overall health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries

Secondary study objectives

Biochemical parameter: serum A1c

Biochemical parameter: serum Cystatin C

Biochemical parameter: serum potassium

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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