About this trial
Standard chronic kidney disease (CKD) guidelines frequently restrict nut intake due to concerns regarding their phosphorus and potassium content. While uncontrolled phosphorus loading exacerbates secondary hyperparathyroidism, vascular calcification, and mortality, overly restrictive diets can preclude the intake of essential cardioprotective nutrients. Phytate (myo-inositol hexaphosphate), abundant in fiber-rich foods like pistachios, acts as a natural inhibitor of calcium salt deposition, potentially mitigating vascular calcification. Crucially, the phosphorus in nuts is largely organically bound as phytate, which resists enzymatic cleavage in the human gastrointestinal tract, significantly reducing its intestinal bioavailability. Given these properties, moderate pistachio consumption may offer cardiovascular benefits without compromising mineral metabolism. This study aims to evaluate the short-term effects of pistachio supplementation on circulating and urinary phosphorus, parathyroid hormone (PTH) in patients with CKD. This study is an open-label, randomized, controlled crossover clinical trial involving patients with stage 4 and 5 (non-dialysis) CKD. All participants will undergo a 1-week run-in period to initiate a standardized pre-dialysis renal diet (protein 0.8 g/kg/day, potassium 39 mg/kg/day, phosphorus 12 mg/kg/day). Following the run-in, participants will be randomized (1:1 ratio) to one of two 4-week dietary sequences of Pistachio Diet period (30 g/day of pistachios) or Control Diet period. The sequences will be separated by a 4-week washout period. Venous blood and 24-hour urine samples will be collected and serum biomarkers: Phosphorus, potassium, PTH, FGF23, MDA, fasting glucose, creatinine, lipid profile, high-sensitivity C-reactive protein (CRP), and alkaline phosphatase and urinary phosphorus, sodium, uric acid, and potassium will be measured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Stage 4 or 5 non-dialysis CKD, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
Disqualifiers
Unwillingness or inability to provide informed consent.
History of renal replacement therapy (maintenance dialysis or renal transplantation).
Baseline hyperphosphatemia.
Known allergy to pistachios.
Trial design
Crossover
Treatments tested in this trial
Pistachio
Other interventionA pre-dialysis renal diet providing targeted macronutrient and mineral allotments (protein: 0.8 g/kg/day, potassium: 39 mg/kg/day, phosphorus: 12 mg/kg/day supplemented with 30 g/day of pistachios. A low-sodium guideline will be maintained.
Control
Other interventionThe identical baseline renal diet without pistachios, isoenergetically substituted with 60 g of white bread and one tablespoon of olive oil.
Treatment groups
Trial outcomes
Primary outcomes
Urinary Phosphorus
Phosphorus concentration in 24-hour urine sample
Serum phosphorus
Serum concentration of phosphorus
Serum PTH
Serum concentrations of parathyroid hormone
Other outcomes
Urinary K
24-h Urinary K
Serum FGF23
serum concentration of fibroblast growth factor 23
Serum MDA
serum concentration of malondialdehyde
lipid profile
serum concentrations of TG, cholesterol, LDL-cholesterol, and HDL-cholesterol
Sponsors and contacts
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