Pistachio Consumption in Patients With Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShahid Beheshti University of Medical Sciences

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Pistachio

    Other intervention

    A 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 intervention

    The identical baseline renal diet without pistachios, isoenergetically substituted with 60 g of white bread and one tablespoon of olive oil.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Pistachio-Supplemented DietExperimental treatment 1 intervention
Group B: Control diet:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Urinary Phosphorus

Phosphorus concentration in 24-hour urine sample

Time frame
4 weeks
2

Serum phosphorus

Serum concentration of phosphorus

Time frame
4 weeks
3

Serum PTH

Serum concentrations of parathyroid hormone

Time frame
4 weeks

Secondary outcomes

Other outcomes

1

Urinary K

24-h Urinary K

Time frame
4 weeks
2

Serum FGF23

serum concentration of fibroblast growth factor 23

Time frame
4 weeks
3

Serum MDA

serum concentration of malondialdehyde

Time frame
4 weeks
4

lipid profile

serum concentrations of TG, cholesterol, LDL-cholesterol, and HDL-cholesterol

Time frame
4 weeks

Sponsors and contacts

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