Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

NCT03169829 | Withdrawn

• 1 other identifier: 17-00455
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Disease

Keywords

Hemodialysis; Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Hemodialysis Patients

EXPERIMENTAL

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

Standard Diet DIETARY_SUPPLEMENT

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

Hemodialysis Patients

Low-k DIETARY_SUPPLEMENT

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

Hemodialysis Patients

Standard DIETARY_SUPPLEMENT

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

Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving thrice-weekly outpatient HD treatments for end-stage renal disease
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David St Jules, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: January 30, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: February 1, 2019

Record last verified: 2019-01