Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

Study Overview
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Brief Summary
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The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and potassium homeostasis in hemodialysis (HD) patients.

Official Title
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Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

Conditions
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Renal Disease

Intervention / Treatment
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* Dietary Supplement: Standard Diet
* Dietary Supplement: Low-k
* Dietary Supplement: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving thrice-weekly outpatient HD treatments for end-stage renal disease 3-month mean serum potassium and phosphorus concentrations of >4.5 mEq/L and >4.0 mg/dL, respectively No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., kidney transplant) Exclusion Criteria: Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, beta-blockers) in the last month Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea) Anemic, defined as a serum hemoglobin concentration <9.0 g/dL Inadequate dialysis efficacy, defined as a Kt/V of <1.2 Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods) Pregnant or planning to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysis Patients<br>Phosphorus and potassium homeostasis will be assessed based on the concentrations of phosphorus and potassium in blood samples collected in fasting, post-prandial, mid-afternoon, pre-dialysis states, as well as the concentrations of phosphorus-regulatory factors, calcitriol, parathyroid hormone and fibroblast growth factor-23. The participants will be transitioned gradually to a plant-rich diet | Dietary Supplement: Standard Diet<br>* Adapted from National Kidney Foundation guidelines for HD1 Animal only Protein Refined only Grains Limit Dairy Low-k only<br>Dietary Supplement: Low-k<br>* •¼ Animal, ¾ Plant Proteins •½ Refined, ½ Whole Grain Limit Dairy, provide Soymilk Dairy Low-k only Fruit and Vegetables<br>Dietary Supplement: Standard<br>* •¼ Animal, ¾ Plant Proteins Refined, ½ Whole Grain •Limit Dairy, provide Soymilk Dairy Low-k, Fruit and Vegetables High-k Fruit and Vegetables<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dialysis serum potassium concentrations. | Pre-dialysis blood samples will be collected by dialysis center staff, and delivered to the Tisch Laboratory by study staff on each dialysis day. | Day 1 | 
| Pre-dialysis serum phosphorus concentrations. | Post-prandial blood tests will be obtained after the participant consumed the standard meal providing 20% of estimated energy requirements corresponding to the research diet | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Renal Disease