NCT04419948

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Harokopio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-05-16
• Primary completion: 2020-12-01
• Completion: 2021-07-01
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Greece