Renal Disease
Conditions
Keywords
Hemodialysis, Renal Disease
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.
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
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-dialysis serum potassium concentrations. | Day 1 | Pre-dialysis blood samples will be collected by dialysis center staff, and delivered to the Tisch Laboratory by study staff on each dialysis day. |
| Pre-dialysis serum phosphorus concentrations. | Day 7 | 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 |
Outcome results
None listed