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

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

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.).

Study Overview

• Status: Completed
• Conditions: Cardiometabolic Risk
• Intervention / Treatment: Other: Control; Other: Functional olive oil, enhanced with orange peel extract

Detailed 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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Myrina, Greece, 81 400
    • University of the Aegean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; The meal contained mashed potatoes, homogenized with refined olive oil.	Other: Control; Refined olive oil
Other: Interventional; The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract	Other: Functional olive oil, enhanced with orange peel extract; The functional olive oil was enriched with 10% w/w orange peel extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours	Plasma Total Antioxidant Capacity concentration	3 hours
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours	Serum total cholesterol concentration	3 hours
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
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours	Serum glucose concentration	3 hours
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours	Serum triglycerides concentration	3 hours
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours	Serum Uric Acid concentration	3 hours

Collaborators and Investigators

• Sponsor: University of the Aegean

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): May 19, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiometabolic risk; Novel olive oil; Orange peel extract; Postprandial bioactivity
• Other Study ID Numbers: Bio622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No one individual participant data is planned to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No