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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07710183
Enrollment
100
Registered
2026-07-17
Start date
2026-07-20
Completion date
2027-04-01
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

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.

Interventions

DIETARY_SUPPLEMENTPumpkin 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.

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

Sponsors

Al-Mustansiriyah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Serum Interleukin-6 (IL-6) levelBaseline and 3 monthsChange in serum Interleukin-6 (IL-6) level
Serum high-sensitivity C-reactive protein (hsCRP) levelBaseline and 3 monthsChange in high-sensitivity C-reactive protein (hsCRP) level
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levelBaseline and 3 monthsChange in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levelsBaseline and 3 monthsChange in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
Serum malondialdehyde (MDA) levelBaseline and 3 monthsChange in malondialdehyde (MDA) level
Serum superoxide dismutase (SOD) activityBaseline and 3 monthsChange in superoxide dismutase (SOD) activity

Countries

Iraq

Contacts

CONTACTmohammed mahmood M mohammed, professor
pharm.drmhdclinical@uomustansiriyah.edu.iq07816871131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026