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

NCT04419948 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-06-09

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

White bread

White bread (120g) containing 54 g CHO

OTHER

Butter

Butter 39 g

OTHER

Refined olive oil

Refined olive oil (40 ml).

OTHER

EVOO with 250 mg/kg oleocanthal

Extra virgin olive oil containing 250 mg/kg oleocanthal.

OTHER

EVOO with 500 mg/kg oleocanthal

Extra virgin olive oil containing 500 mg/kg oleocanthal.

OTHER

Ibuprofen

Ibuprofen 400 mg

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER
  • University of Peloponnese

    collaborator OTHER
  • Harokopio University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2020-12-31
Completion
2021-07-31

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419948 on ClinicalTrials.gov