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WithdrawnNCT03169829Updated Feb 1, 2019

Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

An interventional study of Standard Diet and Low-k in Renal Disease, sponsored by NYU Langone Health. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Due to lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Disease

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Keywords

  • Hemodialysis
  • Renal Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Dietary Supplement: Low-k · Dietary Supplement: Standard

Interventions

  • Dietary supplementStandard Diet

    Adapted from National Kidney Foundation guidelines for HD1 * Animal only Protein * Refined only Grains * Limit Dairy * Low-k only

  • Dietary supplementLow-k

    •¼ Animal, ¾ Plant Proteins •½ Refined, ½ Whole Grain * Limit Dairy, provide Soymilk Dairy * Low-k only Fruit and Vegetables

  • Dietary supplementStandard

    •¼ Animal, ¾ Plant Proteins * Refined, ½ Whole Grain •Limit Dairy, provide Soymilk Dairy * Low-k, Fruit and Vegetables * High-k Fruit and Vegetables

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

  2. 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

    Time frame: Day 7

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03169829
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
May 30, 2017
Start date
Jan 30, 2019
Primary completion
Sep 2022 (estimated)
Completion
Sep 2023 (estimated)
Last update
Feb 1, 2019

Study contacts

David St Jules, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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