Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Refined Olive Oil; Dietary Supplement: Extra-Virgin Olive Oil

• Registration Number: NCT03796780
• Lead Sponsor: Javad Nasrollahzadeh

Brief Summary

Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.

Detailed Description

A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 \[IL-6\] and Interleukine-10 \[IL-10\] and C-Reactive Protein \[CRP\]).

Study Timeline

• Study First Submitted: 2018-12-29
• Study Start: 2019-01-01
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-08
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-07
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
2. willing to participation in the study

Exclusion Criteria

1. Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month
2. َChronic kidney disease stage 5
3. Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refined Olive Oil	Refined Olive Oil	Daily consumption of 25 mL Refined Olive Oil for 6 weeks
Extra-Virgin Olive Oil	Extra-Virgin Olive Oil	Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks

Primary Outcome Measures

Name	Time	Method
Interleukin-6 (IL-6)	6 week	change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6

Secondary Outcome Measures

Name	Time	Method
plasma liver enzymes (SGOT & SGPT)	6 week	change in plasma level of liver enzymes (SGOT \& SGPT) in mg/dL from baseline at 6 week
plasma lipid profile	6 week	change in plasma level of lipoproteins in mg/dL from baseline at 6 week
Interleukin-10 (IL-10)	6 week	Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6
C reactive protein (CRP)	6 week	Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6

Trial Locations

Locations (1)

Rajaei Cardiovascular, Medical & Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of