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Dietary Supplement

Plant-focused low-protein nutrition in diabetic CKD (PLAFOND) for Diabetes (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

Summary

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.

Eligible Conditions
  • Diabetes
  • Diabetic Nephropathy
  • Chronic Kidney Disease
  • Renal Disease
  • Diabetic Kidney Disease

Timeline

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

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
559 Previous Clinical Trials
1,929,889 Total Patients Enrolled
4 Trials studying Diabetes
1,030 Patients Enrolled for Diabetes
VA Long Beach Healthcare SystemFED
15 Previous Clinical Trials
4,625 Total Patients Enrolled
Kamyar Kalantar-Zadeh, MD, MPH, PhDPrincipal InvestigatorUniversity of California
2 Previous Clinical Trials
1,158 Total Patients Enrolled
~74 spots leftby Mar 2026
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