Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients
NCT07710183 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-07-17
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
Interventions
- 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.
Sponsors & Collaborators
-
Al-Mustansiriyah University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-20
- Primary Completion
- 2027-04-01
- Completion
- 2027-04-01
Countries
- Iraq
Study Locations
More Related Trials
-
Palm Tocotrienols in Chronic Hemodialysis (USA)
NCT02358967 ·Status: COMPLETED ·Phase: NA
-
Edible Oils in the Treatment of Constipation of Hemodialysis Patients
NCT02103556 ·Status: COMPLETED ·Phase: NA
-
Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease
NCT01838330 ·Status: COMPLETED ·Phase: NA
-
Effect of Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients
NCT02993380 ·Status: COMPLETED ·Phase: NA
-
Isoflavones and Peritoneal Dialysis
NCT04185168 ·Status: COMPLETED ·Phase: NA
-
Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
NCT05627843 ·Status: UNKNOWN ·Phase: PHASE3
-
Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
NCT02371018 ·Status: COMPLETED ·Phase: NA
-
Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
NCT00172211 ·Status: COMPLETED ·Phase: NA
-
Protein Supplementation During Dialysis (PROSED)
NCT07237997 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
NCT04413266 ·Status: COMPLETED ·Phase: NA
-
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
NCT05817799 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
NCT02166359 ·Status: COMPLETED ·Phase: NA
-
Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
NCT06569732 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease
NCT00566670 ·Status: COMPLETED
-
Activated Charcoal Use in Chronic Kidney Disease Patients
NCT06906874 ·Status: RECRUITING ·Phase: PHASE2
-
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
NCT01147354 ·Status: COMPLETED ·Phase: PHASE3
-
Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)
NCT02913690 ·Status: UNKNOWN ·Phase: NA
-
The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
NCT07060040 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Oral Nutritional Supplement on Nutritional and Functional Status, and Biomarkers in Malnourished Hemodialysis Patients.
NCT03924089 ·Status: COMPLETED ·Phase: NA
-
Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
NCT04628117 ·Status: UNKNOWN ·Phase: NA
-
Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
NCT01356433 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Short-chain Fatty Acids on Inflammatory and Metabolic Parameters in Maintenance Hemodialysis
NCT02976688 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Polydextrose for Patients With Chronic Kidney Disease
NCT05336305 ·Status: COMPLETED ·Phase: NA
-
Protein Supplementation In Dialysis Patients
NCT03367000 ·Status: COMPLETED ·Phase: NA
-
The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
NCT03773029 ·Status: UNKNOWN ·Phase: NA