The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Drug: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "

Detailed Description

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:

• Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
• Group 2 (Control group): consists of 28 patients who will not receive the intervention.

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pumpkin Seed Oil group; Group 1 (Pumpkin Seed Oil group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "	Drug: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "; 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 (≤ 2.4%); Other Names: Pepon
No Intervention: Control group; Group 2 (Control group): consists of 28 patients who will not receive the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RHDIRB2020110301 REC #241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No