Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients

Sponsor
Al-Mustansiriyah University
Study ID
NCT07710183
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

First listed
Jul 17, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Usual Care (Control)
    Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.

Primary Outcome Measure

Serum Interleukin-6 (IL-6) level [ Time Frame: Baseline and 3 months ]

Central Contacts

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