Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients

NCT07710183 | Recruiting DMC

• 1 other identifier: SOP117
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease; Chronic Kidney Disease Requiring Chronic Dialysis; Inflammation; Oxidative Stress

Keywords

Pumpkin seed oil; Hemodialysis; IL-6; hsCRP; sVCAM-1; Malondialdehyde; Superoxide dismutase; Lipid profile

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Pumpkin Seed Oil + Usual Care

EXPERIMENTAL

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; Procedure: Standard hemodialysis care

Usual Care (Control)

ACTIVE COMPARATOR

Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.

Procedure: Standard hemodialysis care

Interventions

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.

Pumpkin Seed Oil + Usual Care

Standard hemodialysis care PROCEDURE

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

Pumpkin Seed Oil + Usual Care; Usual Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Al-Karama Teaching Hospital, Hemodialysis Center

Baghdad, Karkh, 10064, Iraq

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mohammed mahmood M mohammed, professor

CONTACT

07816871131; pharm.drmhdclinical@uomustansiriyah.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

IR (1)