Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq
End-stage renal disease (ESRD) on hemodialysis for more than 6 months, on a constant dialysis program.
Hemodynamically stable (no recent hospitalization for infections, cardiovascular events, or major surgery within the past 3 months).
No active acute infections.
Serum albumin ≥ 3.0 g/dL.
Regular intake of dietary supplements (e.g., omega-3, antioxidants) for at least one month prior to enrollment.
Autoimmune disease, liver disease, cancer, or acquired immunodeficiency syndrome (AIDS).
Known sensitivity/allergy to pumpkin seed oil.
Current use of lipid-lowering agents.
Parallel
Pumpkin Seed Oil 1000 mg
Dietary supplementPumpkin seed oil, 1000 mg, oral capsule/tablet, once daily (taken on dialysis days after the dialysis session), for 3 months, added to the standard hemodialysis care protocol.
Standard hemodialysis care
Procedure/SurgeryStandard hemodialysis care per center protocol, with no additional study supplement.
Serum Interleukin-6 (IL-6) level
Change in serum Interleukin-6 (IL-6) level
Serum high-sensitivity C-reactive protein (hsCRP) level
Change in high-sensitivity C-reactive protein (hsCRP) level
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
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