- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514184
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease (PLAFOND)
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease (PLAFOND Study): A Pilot/Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease (CKD) affects 10-15% of US adults including 30-40% of persons with diabetes mellitus (DM), is associated with poor outcomes, and often progresses to requiring dialysis or transplantation. Half of all Americans with CKD also have DM. While traditional and emerging pharmacotherapies are often used in CKD with diabetes (CKD/DM), the synergistic role of dietary interventions has not been well examined. Low-carbohydrate low-fat diets are often recommended in DM, whereas low-protein diets (LPDs) are recommended for non-diabetic CKD with increasing emphasis on plant-based protein sources. Evidence suggests that high-protein diets with greater animal protein content may lead to glomerular hyperfiltration and faster decline in renal function in patients with CKD/DM. There remains major controversy regarding the potential risks vs. benefits of plant-based diets in CKD/DM, for which guidelines remain based on expert opinion. Given conventional dietary restrictions for the management of DM, there is concern that plant-based LPDs may lead to protein-energy wasting and hyperkalemia, whereas these diets may indeed be most beneficial in patients with CKD/DM given their faster rates of CKD progression as compared to non-diabetics. At present, clinical practice guidelines provide conflicting recommendations regarding the amount (low vs. high) and source (plant vs. animal) of dietary protein intake (DPI) in CKD/DM. Given that prior dietary trials in CKD such as the 1994 Modification of Diet in Renal Disease (MDRD) study excluded CKD/DM and did not examine the optimal proportion of plant vs. animal-based proteins, there is urgent unmet need for a rigorous dietary intervention study to examine the efficacy and safety of patient-centered plant-based diets in CKD/DM.
The investigators will conduct a pilot feasibility randomized controlled trial in parallel with patients' routine follow-up visits at ambulatory clinics to test the feasibility and safety of implementing a Plant- Focused Nutrition in CKD/DM (PLAFOND) diet with a DPI of 0.6-0.8 g/kg/d comprised of >2/3 plant-based sources, vs. standard-of-care renal diet with <1/3 plant-sources and low-potassium content, administrated by dietitians, over a 6-month period in 120 patients with CKD/DM stage 3-5. The investigators will determine whether the PLAFOND diet vs. the standard-of-care renal diet can be adhered to with consistent separation in dietary protein and plant-based proportions at 3- and 6-months. The investigators will also examine nutritional status, physical performance, and body composition, as well as glycemic measures using traditional metrics and continuous glucose monitoring, while other biochemical parameters and patient-reported outcomes including CKD-related symptoms will also be studied. In addition to providing the requisite feasibility and safety data of patient-conduct of future multi-center trials, this study will have major immediate impact by reinvigorating the critical role of dietary management of CKD/DM.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kamyar Kalantar-Zadeh, MD, MPH, PhD
- Phone Number: 562-999-4224
- Email: kkz@uci.edu
Study Contact Backup
- Name: Connie M Rhee, MD, MS
- Phone Number: 714-456-5142
- Email: crhee1@uci.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plant-focused low-protein nutrition in diabetic CKD (PLAFOND)
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.
|
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.
Other Names:
|
Active Comparator: Standard-of-care renal diet (control group)
Participants randomized to the control group will receive standard-of-care renal diet with low-potassium content based on dietitian counseling and guidance.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary adherence to PLAFOND vs. standard-of-care low-potassium renal diet assessed by 24-hour urine collections
Time Frame: 6 months
|
Dietary Adherence and separation in dietary components of PLAFOND (plant-based proportions of protein >2/3) vs. low-potassium renal diet (<1/3 plant-based protein) at 3- and 6-months ascertained by and 24-hour urine collections (secondary outcome)
|
6 months
|
Physical function measured by Short Physical Performance Battery (SPPB)
Time Frame: 6 months
|
Under "Nutritional and Physical Performance and Body Composition" physical function will be measured by Short Physical Performance Battery (SPPB), a value between 0 to 12 (higher suggesting more frail phenotype), at baseline, 3-, and 6-months.
|
6 months
|
Physical function measured by Fried Frailty Index
Time Frame: 6 months
|
Under "Nutritional and Physical Performance and Body Composition" physical function will be measured by Fried Frailty Index, a score between 0 and 5, devided into ranking categories of non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5), measured at baseline, 3-, and 6-months.
|
6 months
|
Muscle strength measured by handgrip strength
Time Frame: 6 months
|
Under the "Nutritional and Physical Performance and Body Composition", muscle strength will be measured by handgrip strength using dynamometer, scored using force production in kilograms (0-90), at baseline, 3-, and 6-months.
|
6 months
|
Body composition using caliper anthropometry to measure mid-arm muscle circumference (MAMC)
Time Frame: 6 months
|
Under "Nutritional and Physical Performance and Body Composition", body composition will be assessed using caliper anthropometry to measure mid-arm muscle circumference (MAMC) in cm (<12.5 cm as malnutrition), at baseline, 3-, and 6-months.
|
6 months
|
Body composition using near-infrared interactance
Time Frame: 6 months
|
Under "Nutritional and Physical Performance and Body Composition", body composition will be assessed using caliper anthropometry and near-infrared interactance, producing percentage of body fat (unit: %), at baseline, 3-, and 6-months.
|
6 months
|
Biochemical parameter: serum A1c
Time Frame: 6 months
|
Under "Glycemic, Renal and Safety Endpoints", biochemical parameter hemoglobin A1c, a value in percentage (normal rnage <5.5%), will be measured at baseline, and 1-, 3- and 6-months in all 120 participants
|
6 months
|
Biochemical parameter: serum potassium
Time Frame: 6 months
|
Under "Glycemic, Renal and Safety Endpoints", biochemical parameter serum potassium, a valie in mEq/L (normal range: 3.5-5.3
mEq/L), will be measured at baseline, and 1-, 3- and 6-months in all 120 participants
|
6 months
|
Biochemical parameter: serum Cystatin C
Time Frame: 6 months
|
Under "Glycemic, Renal and Safety Endpoints", biochemical parameter serum Cystatin C (mg/L) will be measured at baseline, and 1-, 3- and 6-months in all 120 participants
|
6 months
|
Biochemical parameter: urinary albumin to creatinine ratio (ACR)
Time Frame: 6 months
|
Under "Glycemic, Renal and Safety Endpoints", biochemical parameters including hemoglobin A1c, potassium, and Cystatin C and albumin to creatinine ratio (ACR) in mg/g will be measured at baseline, and 1-, 3- and 6-months in all 120 participants
|
6 months
|
Glycemic status by continuous glucose monitoring (GCM)
Time Frame: 6 months
|
Under "Glycemic Endpoints", glycemic status ascertained by continuous glucose monitoring (CGM) via DEXCOM will be examined in a substudy of 50 patients at baseline and at 6-months.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kamyar Kalantar-Zadeh, MD, MPH, PhD, University of California
- Principal Investigator: Connie M Rhee, MD, MS, University of California
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Veterans
- high-protein diet
- animal protein
- continuous glucose monitoring (CGM)
- dietary education
- plant-dominant low protein (PLADO) diet
- plant-focused nutrition in CKD/DM (PLAFOND) diet
- plant-based protein
- glomerular hyperfiltration
- potassium restricted diet
- renal disease progression
- pilot/feasibility randomized controlled trial
- diet adherence
- meal plans
- renal diet
- CKD-related symptoms
- 24-hour urine nitrogen
- Cystatin C and associated eGFR
- Medical Nutrition Therapy (MNT)
- uremic symptoms
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetes Complications
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Diabetes Mellitus
- Kidney Diseases
- Renal Insufficiency, Chronic
- Diabetic Nephropathies
Other Study ID Numbers
- 1750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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