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The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.
The main question it aims to answer is:
ā¢ Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?
Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.
This study aims to investigate the effects of PSO supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients via assessment of IL-6, MDA, lipid profile, and kidney function tests.
Patients & Methods:
Design: Prospective, randomized, Open label - controlled clinical trial.
Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:
Setting: Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.
Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pumpkin Seed Oil group | Experimental | Group 1 (Pumpkin Seed Oil group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " RonkinĀ®, KMT PHARMA, Egypt. " |
|
| Control group | No Intervention | Group 2 (Control group): consists of 28 patients who will not receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumpkin Seed Oil " RonkinĀ®, KMT PHARMA, Egypt. " | Dietary Supplement | Ronkin soft gelatin capsules, each containing 1010 mg of pumpkin seed oil (Latin name: Curcurbita pepo), standardized to contain palmitic acid (8-15%), stearic acid (3-8%), oleic acid (15-35%), linoleic acid (40-65%), and other fatty acids (ā¤ 2.4%) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients. | To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker. | 12 weeks |
| To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients. | To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients. | To evaluate the effect of PSO supplementation on the lipid profile, include triglyceride (TG), total cholesterol (TC), LDL, and HDL measurements. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt. | Cairo | 11766 | Egypt |
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Design: Prospective, randomized, Open label - controlled clinical trial.
Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:
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