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

March 16, 2023 updated by: ANTONIOS KOUTELIDAKIS, University of the Aegean

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 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
Time Frame: 3 hours
Serum LDL-cholesterol concentration
3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 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
Time Frame: 3 hours
Serum HDL-cholesterol (HDL-cholesterol) concentration
3 hours
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 3 hours
Serum glucose concentration
3 hours
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 3 hours
Serum triglycerides concentration
3 hours
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 3 hours
Serum Uric Acid concentration
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Aegean

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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