Plant-Focused Diet for Diabetes and Chronic Kidney Disease

(PLAFOND Trial)

Recruiting 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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the PLAFOND diet treatment for diabetes and chronic kidney disease?

Research suggests that plant-based diets can help slow the progression of chronic kidney disease and improve insulin sensitivity, which is beneficial for diabetes management. Additionally, a plant-dominant, low-protein diet may reduce the risk of kidney disease progression and improve heart health. ^{1 2 3 4 5}

Is a plant-focused diet safe for people with diabetes and chronic kidney disease?

A plant-focused diet, like the PLADO diet, is considered safe and may even be beneficial for people with chronic kidney disease, as it can help manage kidney function and reduce cardiovascular risks. It emphasizes low protein intake from mostly plant sources, which can be heart-healthy and feasible for managing kidney disease without the need for dialysis. ^{1 4 6 7 8}

How is the PLAFOND diet treatment different from other treatments for diabetes and chronic kidney disease?

The PLAFOND diet is unique because it focuses on a plant-based eating pattern, which has been shown to improve blood sugar control, body weight, and cholesterol levels more effectively than traditional diets. This approach emphasizes whole grains, vegetables, fruits, and legumes, and excludes animal products, potentially reducing the risk of complications associated with diabetes and chronic kidney disease. ^{1 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Kamyar Kalantar-Zadeh, MD, MPH, PhD

Principal Investigator

University of California

Connie M Rhee, MD, MS

Principal Investigator

University of California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Plant-based diets, insulin sensitivity and inflammation in elderly men with chronic kidney disease. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Fiber Intake (Supplemental or Dietary Pattern Rich in Fiber) and Diabetic Kidney Disease: A Systematic Review of Clinical Trials. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Plant-Dominant Low-Protein Diet for Conservative Management of Chronic Kidney Disease. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A qualitative analysis of eating behaviour change for patients with diabetes and non-dialysis dependent chronic kidney disease stages 4-5. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Dietary approaches to stop hypertension, mediterranean dietary pattern, and diabetic nephropathy in women with type 2 diabetes: A case-control study. [2020]

7. Bulgaria pubmed.ncbi.nlm.nih.gov

[Differences in the dietary intake of diabetics with and without early nephropathy]. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. [2023]

9. United States 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of plant-based diets in promoting well-being in the management of type 2 diabetes: a systematic review. [2020]

11. United States 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. [2022]