Safety and Efficacy of Plant-based Diets in Hemodialysis Patients

NCT ID: NCT03169829

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Standard Diet

Intervention Type: DIETARY_SUPPLEMENT

Adapted from National Kidney Foundation guidelines for HD1

• Animal only Protein
• Refined only Grains
• Limit Dairy
• Low-k only

Low-k

Intervention Type: DIETARY_SUPPLEMENT

•¼ Animal, ¾ Plant Proteins

•½ Refined, ½ Whole Grain

• Limit Dairy, provide Soymilk Dairy
• Low-k only Fruit and Vegetables

Standard

Intervention Type: 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

Interventions

Standard Diet

Adapted from National Kidney Foundation guidelines for HD1

• Animal only Protein
• Refined only Grains
• Limit Dairy
• Low-k only

Intervention Type: DIETARY_SUPPLEMENT

Low-k

•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

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David St Jules, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

17-00455

Identifier Type: -

Identifier Source: org_study_id