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
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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