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NCT Number: NCT07710183

Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Karama Teaching Hospital, Hemodialysis Center

Baghdad, Karkh, 10064, Iraq

Location status: Recruiting

Location contact

Rana Bahaa Mohammed, MSc

CONTACT

[email protected]

7705846087 ext. 00964

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pumpkin Seed Oil 1000 mg

Dietary Supplement

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

Procedure

Standard hemodialysis care per center protocol, with no additional study supplement.

Primary outcomes

  1. Serum Interleukin-6 (IL-6) level

    Time frame: Baseline and 3 months

    Change in serum Interleukin-6 (IL-6) level

  2. Serum high-sensitivity C-reactive protein (hsCRP) level

    Time frame: Baseline and 3 months

    Change in high-sensitivity C-reactive protein (hsCRP) level

  3. Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level

    Time frame: Baseline and 3 months

    Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level

  4. Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels

    Time frame: Baseline and 3 months

    Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level

  5. Serum malondialdehyde (MDA) level

    Time frame: Baseline and 3 months

    Change in malondialdehyde (MDA) level

  6. Serum superoxide dismutase (SOD) activity

    Time frame: Baseline and 3 months

    Change in superoxide dismutase (SOD) activity

Study contacts

Contact information is provided by the study sponsor or research team.

mohammed mahmood M mohammed, professor

CONTACT

[email protected]

07816871131 ext. +964

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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