Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

Renal Disease Clinical Trial

Official title:

Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03169829
• Other study ID #: 17-00455
• Status: Withdrawn
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: September 2023

Study information

• Verified date: January 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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