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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：mohammed mahmood M mohammed, professor
- 電話番号：+964 07816871131
- メール：pharm.drmhdclinical@uomustansiriyah.edu.iq
研究場所
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Karkh
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Baghdad、Karkh、イラク、10064
- 募集
- Al-Karama Teaching Hospital, Hemodialysis Center
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コンタクト：
- Rana Bahaa Mohammed, MSc
- 電話番号：00964 7705846087
- メール：rana_clinicalphd@uomustansiriyah.edu.iq
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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アクティブコンパレータ：Usual Care (Control)
Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.
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Standard hemodialysis care per center protocol, with no additional study supplement.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Interleukin-6 (IL-6) level
時間枠：Baseline and 3 months
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Change in serum Interleukin-6 (IL-6) level
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Baseline and 3 months
|
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Serum high-sensitivity C-reactive protein (hsCRP) level
時間枠：Baseline and 3 months
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Change in high-sensitivity C-reactive protein (hsCRP) level
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Baseline and 3 months
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Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
時間枠：Baseline and 3 months
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Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
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Baseline and 3 months
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Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
時間枠：Baseline and 3 months
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Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
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Baseline and 3 months
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Serum malondialdehyde (MDA) level
時間枠：Baseline and 3 months
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Change in malondialdehyde (MDA) level
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Baseline and 3 months
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Serum superoxide dismutase (SOD) activity
時間枠：Baseline and 3 months
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Change in superoxide dismutase (SOD) activity
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Baseline and 3 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SOP117
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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