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Withdrawn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