Oleocanthal Rich Olive Oil Acute Effects on Hyperglycemia and Platelet Activation in T2DM

June 3, 2020 updated by: Tzortzis Nomikos, Harokopio University

Acute Effect of Oleocanthal Rich Extra-virgin Olive Oil on Postpranial Hyperglycemia and Platelet Activation of T2DM Patients

This is a pilot acute dietary intervention study with a randomized cross-over design aiming to investigate whether acute supplementation of extra virgin olive oil (EVOO) rich in oleocanthal could attenuate postprandial hyperglycemia and activation of platelets in T2DM patients. For this reason, non-insulin dependent diabetic patients (10-15) will be randomly assigned to consume in five different days white bread (50 g CHO) with butter, butter with ibuprofen, refined olive oil and olive oil with oleocanthal (250 mg/Kg 500 mg/Kg). Blood samples will be collected pre- and post-intervention up to 4 hours in order to determine platelet aggregation, postprnadial glycemia, lipemia, inflammation and oxidative stress.

Taking into account the strong anti-inflammatory and anti-platelet properties of oleocanthal, this study will assess whether oleocanthal-rich olive oils could exert similar effects under real in vivo conditions in T2DM patients. It will also assess whether these effects are achieved through improvement of postprandial glycemia and lipemia.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
15

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Greece
    • I Am Not In The U.S. Or Canada
      • Athens, I Am Not In The U.S. Or Canada, Greece, 17671
        • Recruiting
        • Department of Nutrition and Dietetics, Harokopio University
        • Contact:
          • Tzortzis Nomikos, PhD
          • Phone Number: 00302109358920
          • Email: tnomikos@hua.gr
        • Contact:
        • Principal Investigator:
          • Tzortzis Nomikos, PhD
        • Sub-Investigator:
          • Maria Efthymia Katsa, MSc
        • Sub-Investigator:
          • Kleopatra Ketselidi, Bachelor

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients diagnosed with T2DM
  • stable weight the last two months
  • smokers or not
  • no restriction regarding the menopause

Exclusion Criteria:

  • insulin therapy
  • antiplatelet, anti-coagulant, anti-inflammatory and anti-depressant medication
  • chronic inflammatory disease
  • autoimmune diseases
  • cancer
  • uncontrolled thyroid disease.
  • supplement consumption the last two months

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: Other
  • 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.
Experimental: Control
100g white bread plus 40ml butter
Other: White bread
White bread (120g) containing 54 g CHO
Other: Butter
Butter 39 g
Experimental: Positive control
100g white bread plus 40ml butter and 400mg ibuprofen
Other: White bread
White bread (120g) containing 54 g CHO
Other: Butter
Butter 39 g
Other: Ibuprofen
Ibuprofen 400 mg
Experimental: Refined olive oil
100g white bread plus 40ml refined olive oil
Other: White bread
White bread (120g) containing 54 g CHO
Other: Refined olive oil
Refined olive oil (40 ml).
Experimental: EVOO with moderate concentration of oleocanthal
100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal
Other: White bread
White bread (120g) containing 54 g CHO
Other: EVOO with 250 mg/kg oleocanthal
Extra virgin olive oil containing 250 mg/kg oleocanthal.
Experimental: EVOO with high concentration of oleocanthal
100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal
Other: White bread
White bread (120g) containing 54 g CHO
Other: EVOO with 500 mg/kg oleocanthal
Extra virgin olive oil containing 500 mg/kg oleocanthal.

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
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption
Time Frame: 0 and 90 after the consumption of each type of meal
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 90 after the consumption of each type of meal
Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption
Time Frame: 0 and 240 after the consumption of each type of meal
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 240 after the consumption of each type of meal
Change from baseline of TRAP-induced platelet aggregation at 90 min after meals consumption
Time Frame: 0 and 90 after the consumption of each type of meal
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 90 after the consumption of each type of meal
Change from baseline of TRAP-induced platelet aggregation at 240 min after meals consumption
Time Frame: 0 and 240 after the consumption of each type of meal
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 240 after the consumption of each type of meal
Change from baseline of PAF-induced platelet aggregation at 90 min after meals consumption
Time Frame: 0 and 90 after the consumption of each type of meal
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 90 after the consumption of each type of meal
Change from baseline of PAF-induced platelet aggregation at 240 min after meals consumption
Time Frame: 0 and 240 after the consumption of each type of meal
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
0 and 240 after the consumption of each type of meal
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Glucose
Time Frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial glucose will be calculated by serum glucose levels (mg/dL) which will be assessed by commercially available kits
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Insulin
Time Frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial insulin will be calculated by serum insulin levels (mIU/L) which will be assessed by commercially available kits
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Triglycerides
Time Frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal

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
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6
Time Frame: 0, 60, 120, 180, 240 min after the consumption of each meal
iAUC of postprandial IL-6 will be calculated by serum IL-6 levels (mg/dL) which will be assessed by commercially available ELISA kits
0, 60, 120, 180, 240 min after the consumption of each meal
Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls
Time Frame: 0, 60, 120, 180, 240 min after the consumption of each meal
iAUC of postprandial protein carbonyls will be calculated by plasma protein carbonyl levels (mg/dL) which will be determined by a photometric assay
0, 60, 120, 180, 240 min after the consumption of each meal

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.
Harokopio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National and Kapodistrian University of Athens
University of Peloponnese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 16, 2019

Primary Completion (Anticipated)

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.
December 1, 2020

Study Completion (Anticipated)

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.
July 1, 2021

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).
February 24, 2020

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.
June 3, 2020

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.
June 9, 2020

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.
June 9, 2020

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.
June 3, 2020

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.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 79549/16-05-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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