Plant-Focused Diet for Diabetes and Chronic Kidney Disease

(PLAFOND Trial)

Enrolling by invitation at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Terminal illness, High potassium, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a plant-focused diet can help individuals with both diabetes and chronic kidney disease (CKD) manage their conditions more effectively. Participants will either follow a plant-based diet plan (the PLAFOND diet) or adhere to the usual low-potassium and low-salt diet for CKD. The main goal is to determine if the plant-based diet is easy for patients to follow, safe from causing issues like malnutrition or high potassium levels, and if it enhances their quality of life. Suitable candidates have diabetes and CKD stages 3 to 5 and wish to avoid or delay starting dialysis. As an unphased trial, this study provides a unique opportunity to contribute to understanding how dietary changes can impact health management for those with diabetes and CKD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PLAFOND diet is safe for patients with diabetes and chronic kidney disease?

Research has shown that plant-based diets, such as the PLAFOND diet, can benefit people with diabetes and chronic kidney disease. However, some safety concerns exist. Studies indicate that a low-protein diet is generally safe for these conditions, but experts continue to discuss the pros and cons of varying protein intake.

The PLAFOND diet emphasizes plants and is low in protein. Researchers are testing its ease of adherence and health benefits. The goal is to prevent issues like malnutrition, weakness, and high levels of potassium or sugar in the blood. With guidance from dietitians, this diet aims to be safe while helping manage diabetes and kidney disease.

Although specific safety data for this diet is not yet available, testing it in a trial suggests experts recognize its potential. Always consult a healthcare professional before changing your diet, especially if you have ongoing health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard renal diets for diabetes and chronic kidney disease, which usually focus on low potassium intake, the PLAFOND diet emphasizes a plant-focused, low-protein approach. Researchers are excited about the PLAFOND diet because it incorporates more than two-thirds of protein from plant-based sources, which may offer better kidney protection and overall health benefits. This novel dietary strategy could potentially improve outcomes for patients by reducing the strain on their kidneys while still managing their diabetic needs.

What evidence suggests that the PLAFOND diet could be effective for diabetes and chronic kidney disease?

Research has shown that a plant-focused, low-protein diet may benefit individuals with diabetes and chronic kidney disease (CKD). Studies on similar diets have found they can slow the progression of CKD. This trial will compare the PLAFOND diet, a plant-focused low-protein nutrition plan, with a standard-of-care renal diet. The PLAFOND diet may also reduce the need for dialysis, which cleans the blood when the kidneys cannot. By increasing plant-based food intake, the diet can improve heart health by reducing the acid load from food. While more research is needed to confirm these benefits specifically for the PLAFOND diet, these findings suggest it could have positive effects. ^{1 2 3 5 6}

Who Is on the Research Team?

Kamyar Kalantar-Zadeh, MD, MPH, PhD

Principal Investigator

University of California

Connie M Rhee, MD, MS

Principal Investigator

University of California

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to follow the diet plan and attend all required visits or calls.

I am an adult with diabetes and kidney disease stage 3-5, wanting to avoid dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the PLAFOND diet or standard-of-care renal diet, with dietary adherence and biochemical parameters monitored over a 6-month period

6 months

Visits at baseline, 1-, 3-, and 6-months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PLAFOND diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Plant-focused low-protein nutrition in diabetic CKD (PLAFOND) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

VA Long Beach Healthcare System

Collaborator

Trials

16

Recruited

4,500+

Published Research Related to This Trial

In a 20-week trial involving 40 participants with type 2 diabetes, both a low-fat vegan eating plan and a portion-controlled eating plan led to significant improvements in body weight, hemoglobin A1c (HbA1c), and LDL cholesterol levels, indicating effective dietary interventions for diabetes management.

Despite the improvements in metabolic markers, there were no significant differences between the two eating plans, suggesting that both approaches can be beneficial for individuals with type 2 diabetes when integrated into a clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. Barnard, ND., Levin, SM., Gloede, L., et al.[2022]

Plant-based diets may help delay the progression of diabetic kidney disease (DKD) by focusing on whole foods and reducing processed foods and advanced glycation end products (AGE).

Current evidence is limited and mostly from smaller studies, highlighting the need for larger trials to better understand the impact of plant-based diets on kidney function and overall health outcomes in DKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. Moorthi, RN., Vorland, CJ., Hill Gallant, KM.[2022]

A plant-based eating pattern, which includes whole grains, vegetables, fruits, and legumes while excluding animal products, is linked to a lower risk of developing type 2 diabetes and is effective in managing the condition.

This diet improves key health markers such as blood glucose levels, body weight, and blood pressure, and it also enhances insulin sensitivity and β-cell function, which are crucial for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Jardine, MA., Kahleova, H., Levin, SM., et al.[2023]

In a study involving 35 adults at risk of type 2 diabetes, including 2 eggs daily in a plant-based diet did not negatively impact key cardiometabolic risk factors such as endothelial function, lipid profile, blood pressure, or insulin sensitivity.

Egg inclusion significantly improved dietary intake of important nutrients like selenium and choline, suggesting that eggs can enhance the nutritional quality of plant-based diets for individuals at risk of type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes. Njike, VY., Treu, JA., Kela, GCM., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34750331/

Medical nutrition therapy using plant-focused low-protein meal ... Summary: Potential risks vs benefits of high vs low protein intake in CKD/DM is unknown, for which expert recommendations remain opinion based.

2. reporter.nih.gov reporter.nih.gov/project-details/11160524

A Pilot/Feasibility Study - NIH RePORTER 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 ...

3. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT05514184

Plant-Focused Nutrition in Patients With Diabetes and ... Low-carbohydrate low-fat diets are often recommended in DM, whereas low-protein diets (LPDs) are recommended for non-diabetic CKD with ...

4. mdpi.com mdpi.com/2072-6643/17/6/970

A Plant-Dominant Low-Protein Diet in Chronic Kidney ... Key findings suggest that PLADO can delay CKD progression, reduce dialysis dependence, and mitigate cardiovascular risks through lower dietary acid load, ...

5. journals.lww.com journals.lww.com/10.1097/MNH.0000000000000761

Medical nutrition therapy using plant-focused low-protein... Low-carbohydrate low-fat diets are often recommended in T2D, whereas low-protein diets (LPD) are recommended by guidelines for nondiabetic CKD.

6. sciencedirect.com sciencedirect.com/science/article/pii/S105122762300105X

Nutritional and Dietary Management of Chronic Kidney ... There are currently ongoing studies and trials evaluating the efficacy and safety of the PLADO diet in patients with NDD-CKD, as well as its counterpart in ...