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Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

Primary Purpose

Renal Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard Diet
Low-k
Standard
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Disease focused on measuring Hemodialysis, Renal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hemodialysis Patients

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    January 30, 2019
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03169829
    Brief Title
    Safety and Efficacy of Plant-based Diets in Hemodialysis Patients
    Official Title
    Safety and Efficacy of Plant-based Diets in Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to lack of funding
    Study Start Date
    January 30, 2019 (Actual)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Disease
    Keywords
    Hemodialysis, Renal Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hemodialysis Patients
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Standard Diet
    Intervention Description
    Adapted from National Kidney Foundation guidelines for HD1 Animal only Protein Refined only Grains Limit Dairy Low-k only
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Low-k
    Intervention Description
    •¼ Animal, ¾ Plant Proteins •½ Refined, ½ Whole Grain Limit Dairy, provide Soymilk Dairy Low-k only Fruit and Vegetables
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Standard
    Intervention Description
    •¼ Animal, ¾ Plant Proteins Refined, ½ Whole Grain •Limit Dairy, provide Soymilk Dairy Low-k, Fruit and Vegetables High-k Fruit and Vegetables
    Primary Outcome Measure Information:
    Title
    Pre-dialysis serum potassium concentrations.
    Description
    Pre-dialysis blood samples will be collected by dialysis center staff, and delivered to the Tisch Laboratory by study staff on each dialysis day.
    Time Frame
    Day 1
    Title
    Pre-dialysis serum phosphorus concentrations.
    Description
    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
    Time Frame
    Day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David St Jules, MD
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

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