Hemodialysis Patients Clinical Trial
Official title:
The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
Verified date | January 2024 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: • 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.
Status | Not yet recruiting |
Enrollment | 56 |
Est. completion date | May 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female patients older than 18. - Patients undergoing regular HD for at least 3 months prior to enrollment. - Not participate in any other clinical trials. - Physically stable. Exclusion Criteria: - Patients taking antioxidant supplements prior to the study's two-month time frame. - Patients with autoimmune, liver, cancer diseases and acquired immunodeficiency syndrome (AIDS). - Sensitivity to pumpkin seed oil. - Patients taking warfarin. - History of drug or alcohol abuse. - Pregnant or breastfeeding women and women with the possibility of getting pregnant. - Smokers. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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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