Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

NYU Langone Health

Status: Withdrawn

Conditions: Renal Disease

Treatments: Dietary Supplement: Standard Diet; Dietary Supplement: Low-k; Dietary Supplement: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT03169829

17-00455

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Hemodialysis Patients

Experimental group

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

Treatment:

Dietary Supplement: Low-k

Dietary Supplement: Standard Diet

Dietary Supplement: Standard