Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum Interleukin-6 (IL-6) level
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Serum Interleukin-6 (IL-6) level
时间窗: Baseline and 3 months
Change in serum Interleukin-6 (IL-6) level
Serum high-sensitivity C-reactive protein (hsCRP) level
时间窗: Baseline and 3 months
Change in high-sensitivity C-reactive protein (hsCRP) level
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
时间窗: Baseline and 3 months
Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
时间窗: Baseline and 3 months
Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
Serum malondialdehyde (MDA) level
时间窗: Baseline and 3 months
Change in malondialdehyde (MDA) level
Serum superoxide dismutase (SOD) activity
时间窗: Baseline and 3 months
Change in superoxide dismutase (SOD) activity
次要结局
未报告次要终点
研究者
Mohammed Mahmood Mohammed
Principle Investigator
Al-Mustansiriyah University
