Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients

Официальное название

Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients

Обзор

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

Подробное описание

Chronic systemic inflammation is a cornerstone of hemodialysis pathophysiology, driven by uremic toxin retention, oxidative stress, endotoxemia, and repeated exposure to bioincompatible dialysis membranes, which activate NF-κB and STAT signaling and sustain elevated IL-6 and CRP. These biomarkers are independent predictors of cardiovascular and all-cause mortality, and contribute to the malnutrition-inflammation complex syndrome (MICS) that affects a substantial proportion of dialysis patients. sVCAM-1 acts as a mechanistic bridge between the uremic milieu and accelerated atherosclerosis, mediating monocyte adhesion to the arterial intima and serving as an independent predictor of cardiovascular mortality in this population.

No pharmacological agent is currently routinely or universally prescribed to specifically target inflammation in hemodialysis patients; existing options (e.g., anti-IL-6 agents, statins, pentoxifylline, nutraceuticals such as curcumin, omega-3 fatty acids, and vitamin E) show variable biomarker reductions but have not been widely incorporated into standard practice. Pumpkin seed oil has shown anti-inflammatory and antioxidant effects in animal and in vitro studies, including suppression of IL-1β, IL-6, TNF-α, and COX-2, with effects in some models comparable to NSAIDs. Vitamin E, a major constituent of pumpkin seed oil, has separately been shown to reduce circulating sVCAM-1 in hemodialysis patients via suppression of oxidative stress. However, to the investigators' knowledge, no prior human study has directly examined the impact of pumpkin seed oil on IL-6 and CRP in hemodialysis patients, and no study has investigated its effect on sVCAM-1 specifically in this population.

This study addresses that gap by evaluating the effect of 1000 mg/day oral pumpkin seed oil for 3 months, in addition to usual hemodialysis care, on inflammatory (IL-6, hsCRP, sVCAM-1), oxidative stress (MDA, SOD), and lipid biomarkers, compared with a usual-care control group, in patients with ESRD on maintenance hemodialysis at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq.

Вмешательства

• Пищевая добавка Pumpkin Seed Oil 1000 mg
  Pumpkin 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.
• Процедура Standard hemodialysis care
  Standard hemodialysis care per center protocol, with no additional study supplement.

Первичные конечные точки

• Serum Interleukin-6 (IL-6) level [Срок оценки: Baseline and 3 months]
• Serum high-sensitivity C-reactive protein (hsCRP) level [Срок оценки: Baseline and 3 months]
• Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level [Срок оценки: Baseline and 3 months]
• Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels [Срок оценки: Baseline and 3 months]
• Serum malondialdehyde (MDA) level [Срок оценки: Baseline and 3 months]
• Serum superoxide dismutase (SOD) activity [Срок оценки: Baseline and 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Diabetes mellitus.
• Current use of anticoagulants (warfarin, direct oral anticoagulants).
• Current use of immunosuppressants, corticosteroids, or anti-inflammatory drugs.
• Pregnant or breastfeeding women.
• Residual kidney function (urine output > 200 mL/day).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• Al-Karama Teaching Hospital, Hemodialysis Center — Baghdad

Идентификаторы

NCT: NCT07710183 · SOP117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗