Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients
Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:mohammed mahmood M mohammed, professor
- 电话号码:+964 07816871131
- 邮箱:pharm.drmhdclinical@uomustansiriyah.edu.iq
学习地点
-
-
Karkh
-
Baghdad、Karkh、伊拉克、10064
- 招聘中
- Al-Karama Teaching Hospital, Hemodialysis Center
-
接触:
- Rana Bahaa Mohammed, MSc
- 电话号码:00964 7705846087
- 邮箱:rana_clinicalphd@uomustansiriyah.edu.iq
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Pumpkin Seed Oil + Usual Care
Participants receive pumpkin seed oil 1000 mg orally once daily for 3 consecutive months, in addition to their standard hemodialysis usual care.
|
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.
Standard hemodialysis care per center protocol, with no additional study supplement.
|
|
有源比较器:Usual Care (Control)
Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.
|
Standard hemodialysis care per center protocol, with no additional study supplement.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Interleukin-6 (IL-6) level
大体时间:Baseline and 3 months
|
Change in serum Interleukin-6 (IL-6) level
|
Baseline and 3 months
|
|
Serum high-sensitivity C-reactive protein (hsCRP) level
大体时间:Baseline and 3 months
|
Change in high-sensitivity C-reactive protein (hsCRP) level
|
Baseline and 3 months
|
|
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
大体时间:Baseline and 3 months
|
Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
|
Baseline and 3 months
|
|
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
大体时间:Baseline and 3 months
|
Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
|
Baseline and 3 months
|
|
Serum malondialdehyde (MDA) level
大体时间:Baseline and 3 months
|
Change in malondialdehyde (MDA) level
|
Baseline and 3 months
|
|
Serum superoxide dismutase (SOD) activity
大体时间:Baseline and 3 months
|
Change in superoxide dismutase (SOD) activity
|
Baseline and 3 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.