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

NCT05514184 | Enrolling By Invitation DMC

• 1 other identifier: 1750
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

plant-dominant low protein (PLADO) diet; plant-focused nutrition in CKD/DM (PLAFOND) diet; plant-based protein; glomerular hyperfiltration; high-protein diet; potassium restricted diet; renal disease progression; pilot/feasibility randomized controlled trial; diet adherence; meal plans; renal diet; Veterans; animal protein; continuous glucose monitoring (CGM); CKD-related symptoms; 24-hour urine nitrogen; Cystatin C and associated eGFR; dietary education; Medical Nutrition Therapy (MNT); uremic symptoms

Outcome Measures

Primary Outcomes (1)

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

  Dietary Adherence including separation in dietary plant-based proportions of \>2/3 vs \<1/3 at 3- and 6-months will be ascertained by 3-day diet diaries in all 120 participants as the primary outcome.

  6 months

Secondary Outcomes (11)

• Dietary adherence to PLAFOND vs. standard-of-care low-potassium renal diet assessed by 24-hour urine collections

  6 months

• Physical function measured by Short Physical Performance Battery (SPPB)

  6 months

• Physical function measured by Fried Frailty Index

  6 months

• Muscle strength measured by handgrip strength

  6 months

• Body composition using caliper anthropometry to measure mid-arm muscle circumference (MAMC)

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

Dietary Supplement: PLAFOND diet

Standard-of-care renal diet (control group)

ACTIVE COMPARATOR

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

Dietary Supplement: PLAFOND diet

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.

Also known as: Plant-dominant low protein (PLADO) diet in the form of PLAFOND diet meal plans

Plant-focused low-protein nutrition in diabetic CKD (PLAFOND); Standard-of-care renal diet (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult outpatient (\>18 years old) with diabetes mellitus (DM), who attends ambulatory clinics in one of the two centers, who has the established diagnosis of stage 3-5 CKD and DM regardless of degree of proteinuria, and who wishes to prevent or delay dialysis initiation, is qualified, as long as there are at least 2 eGFRs \<60 ml/min/1.73m2 three months apart with no intervening higher eGFR values.
• Participants will agree to follow the dietary instructions based on the randomization assignment and attend baseline visits as well as three additional ambulatory visits on Month 1, 3 and 6 post-randomization in person or via telehealth and respond to monthly or more frequent phone calls.

You may not qualify if:

• Having a terminal illness with a life expectancy \<6 months such as stage 4 metastatic cancer.
• Patients with any serum potassium \>5.5 mEq/L during the 6 months preceding the screening visit.

Sponsors & Collaborators

• University of California, Irvine: lead
• VA Long Beach Healthcare System: collaborator

Study Sites (2)

UCI

Orange, California, 92868-3217, United States

Location

Harbor-UCLA/Lundquist

Torrance, California, 90502-2004, United States

Location

Related Publications (8)

• Kalantar-Zadeh K, Rhee CM, Joshi S, Brown-Tortorici A, Kramer HM. Medical nutrition therapy using plant-focused low-protein meal plans for management of chronic kidney disease in diabetes. Curr Opin Nephrol Hypertens. 2022 Jan 1;31(1):26-35. doi: 10.1097/MNH.0000000000000761.

  PMID: 34750331 BACKGROUND

• Kalantar-Zadeh K, Joshi S, Schlueter R, Cooke J, Brown-Tortorici A, Donnelly M, Schulman S, Lau WL, Rhee CM, Streja E, Tantisattamo E, Ferrey AJ, Hanna R, Chen JLT, Malik S, Nguyen DV, Crowley ST, Kovesdy CP. Plant-Dominant Low-Protein Diet for Conservative Management of Chronic Kidney Disease. Nutrients. 2020 Jun 29;12(7):1931. doi: 10.3390/nu12071931.

  PMID: 32610641 BACKGROUND

• Kalantar-Zadeh K, Fouque D. Nutritional Management of Chronic Kidney Disease. N Engl J Med. 2017 Nov 2;377(18):1765-1776. doi: 10.1056/NEJMra1700312. No abstract available.

  PMID: 29091561 BACKGROUND

• Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.

  PMID: 34175022 BACKGROUND

• Kistler BM, Moore LW, Benner D, Biruete A, Boaz M, Brunori G, Chen J, Drechsler C, Guebre-Egziabher F, Hensley MK, Iseki K, Kovesdy CP, Kuhlmann MK, Saxena A, Wee PT, Brown-Tortorici A, Garibotto G, Price SR, Yee-Moon Wang A, Kalantar-Zadeh K. The International Society of Renal Nutrition and Metabolism Commentary on the National Kidney Foundation and Academy of Nutrition and Dietetics KDOQI Clinical Practice Guideline for Nutrition in Chronic Kidney Disease. J Ren Nutr. 2021 Mar;31(2):116-120.e1. doi: 10.1053/j.jrn.2020.05.002. Epub 2020 Jul 29.

  PMID: 32737016 BACKGROUND

• Kalantar-Zadeh K, Mattix-Kramer HJ, Moore LW. Culinary Medicine as a Core Component of the Medical Nutrition Therapy for Kidney Health and Disease. J Ren Nutr. 2021 Jan;31(1):1-4. doi: 10.1053/j.jrn.2020.11.002. No abstract available.

  PMID: 33357519 BACKGROUND

• Rhee CM, Kalantar-Zadeh K, Moore LW. Medical Nutrition Therapy for Diabetic Kidney Disease. J Ren Nutr. 2021 May;31(3):229-232. doi: 10.1053/j.jrn.2021.03.004. No abstract available.

  PMID: 33990265 BACKGROUND

• Kalantar-Zadeh K, Saville J, Moore LW. Unleashing the Power of Renal Nutrition in Value-Based Models of Kidney Care Choices: Leveraging Dietitians' Expertise and Medical Nutrition Therapy to Delay Dialysis Initiation. J Ren Nutr. 2022 Jul;32(4):367-370. doi: 10.1053/j.jrn.2022.05.001. Epub 2022 May 16. No abstract available.

  PMID: 35589046 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetic Nephropathies

Interventions

Diet

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kamyar Kalantar-Zadeh, MD, MPH, PhD

  University of California

  PRINCIPAL INVESTIGATOR

• Connie M Rhee, MD, MS

  University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Meal plans in both arms will be administrated by the study dietitians over 6-months among 120 patients with non-dialysis CKD/DM stages 3-5 for 6-months to examine dietary, nutritional, and glycemic endpoints.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This is a pilot/feasibility, two-center (UCI and VA Long Beach), unblinded, randomized controlled trial, conducted in parallel with patients' routine CKD clinic visits, to test feasibility and safety of a patient-centered Plant-Focused Nutrition in CKD/DM (PLAFOND) comprised of \>2/3 plant proteins compared to the standard-of-care renal diet, i.e., low K content with \<1/3 plant protein.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: October 1, 2023
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)