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

NCT ID: NCT04419948

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Adult-Onset Platelet Dysfunction Postprandial Hyperglycemia Lipidemia Inflammation Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Acute postprandial study with a randomized cross-over design
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

100g white bread plus 40ml butter

Group Type EXPERIMENTAL

White bread

Intervention Type OTHER

White bread (120g) containing 54 g CHO

Butter

Intervention Type OTHER

Butter 39 g

Positive control

100g white bread plus 40ml butter and 400mg ibuprofen

Group Type EXPERIMENTAL

White bread

Intervention Type OTHER

White bread (120g) containing 54 g CHO

Butter

Intervention Type OTHER

Butter 39 g

Ibuprofen

Intervention Type OTHER

Ibuprofen 400 mg

Refined olive oil

100g white bread plus 40ml refined olive oil

Group Type EXPERIMENTAL

White bread

Intervention Type OTHER

White bread (120g) containing 54 g CHO

Refined olive oil

Intervention Type OTHER

Refined olive oil (40 ml).

EVOO with moderate concentration of oleocanthal

100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal

Group Type EXPERIMENTAL

White bread

Intervention Type OTHER

White bread (120g) containing 54 g CHO

EVOO with 250 mg/kg oleocanthal

Intervention Type OTHER

Extra virgin olive oil containing 250 mg/kg oleocanthal.

EVOO with high concentration of oleocanthal

100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal

Group Type EXPERIMENTAL

White bread

Intervention Type OTHER

White bread (120g) containing 54 g CHO

EVOO with 500 mg/kg oleocanthal

Intervention Type OTHER

Extra virgin olive oil containing 500 mg/kg oleocanthal.

Interventions

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White bread

White bread (120g) containing 54 g CHO

Intervention Type OTHER

Butter

Butter 39 g

Intervention Type OTHER

Refined olive oil

Refined olive oil (40 ml).

Intervention Type OTHER

EVOO with 250 mg/kg oleocanthal

Extra virgin olive oil containing 250 mg/kg oleocanthal.

Intervention Type OTHER

EVOO with 500 mg/kg oleocanthal

Extra virgin olive oil containing 500 mg/kg oleocanthal.

Intervention Type OTHER

Ibuprofen

Ibuprofen 400 mg

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

University of Peloponnese

OTHER

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Tzortzis Nomikos

Assistant Professor of Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nutrition and Dietetics, Harokopio University

Athens, I Am Not in the U.S. Or Canada, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Tzortzis Nomikos, PhD

Role: CONTACT

00302109358920

Maria Efthymia Katsa, MSc

Role: CONTACT

00306977973450

Facility Contacts

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Tzortzis Nomikos, PhD

Role: primary

00302109358920

Maria Efthymia Katsa, MSc

Role: backup

00306977973450 ext. Nomikos

References

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Agrawal K, Melliou E, Li X, Pedersen TL, Wang SC, Magiatis P, Newman JW, Holt RR. Oleocanthal-rich extra virgin olive oil demonstrates acute anti-platelet effects in healthy men in a randomized trial. J Funct Foods. 2017 Sep;36:84-93. doi: 10.1016/j.jff.2017.06.046. Epub 2017 Jul 3.

Reference Type BACKGROUND
PMID: 29904393 (View on PubMed)

Other Identifiers

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79549/16-05-2019

Identifier Type: -

Identifier Source: org_study_id

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