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

Harokopio University

Status: Unknown

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

Treatments: Other: White bread; Other: Butter; Other: EVOO with 500 mg/kg oleocanthal; Other: Ibuprofen; Other: EVOO with 250 mg/kg oleocanthal; Other: Refined olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04419948

79549/16-05-2019

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 5 patient groups

Control

Experimental group

Description:

100g white bread plus 40ml butter

Treatment:

Other: White bread

Other: Butter

Positive control

Experimental group

Description:

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

Treatment:

Other: Ibuprofen

Other: White bread

Other: Butter

Refined olive oil

Experimental group

Description:

100g white bread plus 40ml refined olive oil

Treatment:

Other: White bread

Other: Refined olive oil

EVOO with moderate concentration of oleocanthal

Experimental group

Description:

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

Treatment:

Other: EVOO with 250 mg/kg oleocanthal

Other: White bread

EVOO with high concentration of oleocanthal

Experimental group

Description:

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

Treatment:

Other: White bread

Other: EVOO with 500 mg/kg oleocanthal