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

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

Study Overview

• Status: Recruiting
• Conditions: Inflammation; End Stage Renal Disease; Oxidative Stress; Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Dietary supplement: Pumpkin Seed Oil 1000 mg; Procedure: Standard hemodialysis care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed mahmood M mohammed, professor; Phone Number: +964 07816871131; Email: pharm.drmhdclinical@uomustansiriyah.edu.iq

Study Locations

• Iraq
  • Karkh
    • Baghdad, Karkh, Iraq, 10064
      • Recruiting
      • Al-Karama Teaching Hospital, Hemodialysis Center
      • Contact: Rana Bahaa Mohammed, MSc; Phone Number: 00964 7705846087; Email: rana_clinicalphd@uomustansiriyah.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.; Procedure: Standard hemodialysis care; Standard hemodialysis care per center protocol, with no additional study supplement.
Active Comparator: Usual Care (Control); Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.	Procedure: Standard hemodialysis care; Standard hemodialysis care per center protocol, with no additional study supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Interleukin-6 (IL-6) level	Change in serum Interleukin-6 (IL-6) level	Baseline and 3 months
Serum high-sensitivity C-reactive protein (hsCRP) level	Change in high-sensitivity C-reactive protein (hsCRP) level	Baseline and 3 months
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level	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	Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level	Baseline and 3 months
Serum malondialdehyde (MDA) level	Change in malondialdehyde (MDA) level	Baseline and 3 months
Serum superoxide dismutase (SOD) activity	Change in superoxide dismutase (SOD) activity	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Malondialdehyde; Hemodialysis; IL-6; Lipid profile; hsCRP; Pumpkin seed oil; sVCAM-1; Superoxide dismutase
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Inflammation; Kidney Failure, Chronic
• Other Study ID Numbers: SOP117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No