Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Disease
• Intervention / Treatment: Dietary supplement: Standard Diet; Dietary supplement: Low-k; Dietary supplement: Standard

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hemodialysis Patients; 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; Adapted from National Kidney Foundation guidelines for HD1; Animal only Protein; Refined only Grains; Limit Dairy; Low-k only; Dietary supplement: Low-k; •¼ Animal, ¾ Plant Proteins •½ Refined, ½ Whole Grain; Limit Dairy, provide Soymilk Dairy; Low-k only Fruit and Vegetables; Dietary supplement: Standard; •¼ Animal, ¾ Plant Proteins; Refined, ½ Whole Grain•Limit Dairy, provide Soymilk Dairy; Low-k, Fruit and Vegetables; High-k Fruit and Vegetables

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David St Jules, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialysis; Renal Disease
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 17-00455

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No