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Dietary Supplement
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
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 moreAwards & 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.
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,932,928 Total Patients Enrolled
4 Trials studying Diabetes
1,030 Patients Enrolled for Diabetes
VA Long Beach Healthcare SystemFED
15 Previous Clinical Trials
4,375 Total Patients Enrolled
Kamyar Kalantar-Zadeh, MD, MPH, PhDPrincipal InvestigatorUniversity of California
2 Previous Clinical Trials
1,158 Total Patients Enrolled
Connie M Rhee, MD, MSPrincipal InvestigatorUniversity of California