Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)

Cardiometabolic Risk Clinical Trial

— BioliveCT  

Official title:

Acute Effect of a Novel, Functional Olive Oil, Enhanced With Orange Peel Extract, on Postprandial Biomarkers of Inflammation and Oxidative Stress of Volunteers at High Cardiometabolic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771571
• Other study ID #: Bio622
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: May 19, 2022

Study information

• Verified date: March 2023
• Source: University of the Aegean
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was the investigation of the hypothesis that the enhancement of a refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to increased content of bioactive compounds (polyphenols, carotenoids etc.).

Description:

In a randomized, acute, single-blinded and cross-over study, participated 21 volunteers with high cardiometabolic risk, aged 30-65, were randomized and divided into two groups. The first group consumed a meal of mashed potatoes with added refined olive oil, rich in fat and carbohydrates (300g, control meal), while the second group consumed mashed potatoes with added olive oil, enhanced with 10% w/w orange peel extract (functional meal). After a one-week washout period, the volunteers were crossed over and consumed the meals in reverse. Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption. Plasma Total Antioxidant Capacity (FRAP), serum lipid levels [Total, High-Density Lipoprotein (HDL-) and Low-Density Lipoprotein (LDL-) cholesterol and triglycerides], glucose and uric acid were determined at each time point using a biochemical analyzer (Roche Cobas c111).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age from 30 to 65 years
• Completion of at least 3 of the following parameters:
• Hypertension (Systolic pressure = 140mm Hydrargyrum or diastolic pressure = 90mm Hydrargyrum or taking antihypertensive treatment)
• High levels of LDL-cholesterol (=130mg/dL)
• High serum triglycerides (=150mg/dL)
• Waist circumference >102cm for men and >98cm for women
• Family history (Myocardial infarction or sudden death in a 1st degree relative <55 years old)
• High fasting glucose (100-125 mg/dL)

Exclusion Criteria:

• Diabetes or antidiabetic treatment
• Age <45 and >65 years
• Malignancies
• Liver disease

Related Conditions & MeSH terms

• Cardiometabolic Risk

Intervention

Other:
• Functional olive oil, enhanced with orange peel extract
The functional olive oil was enriched with 10% w/w orange peel extract
• Control
Refined olive oil

Locations

Country	Name	City	State
Greece	University of the Aegean	Myrina

Sponsors (1)

Lead Sponsor	Collaborator
University of the Aegean

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours	Plasma Total Antioxidant Capacity concentration	3 hours
Primary	Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours	Serum LDL-cholesterol concentration	3 hours
Secondary	Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours	Serum total cholesterol concentration	3 hours
Secondary	Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours	Serum HDL-cholesterol (HDL-cholesterol) concentration	3 hours
Secondary	Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours	Serum glucose concentration	3 hours
Secondary	Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours	Serum triglycerides concentration	3 hours
Secondary	Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours	Serum Uric Acid concentration	3 hours