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

Not Applicable

• Conditions: Platelet Dysfunction; Lipidemia; Oxidative Stress; Diabetes Mellitus, Adult-Onset; Postprandial Hyperglycemia; Inflammation
• Interventions: Other: White bread; Other: Butter; Other: Refined olive oil; Other: EVOO with 250 mg/kg oleocanthal; Other: EVOO with 500 mg/kg oleocanthal; Other: Ibuprofen

• Registration Number: NCT04419948
• Lead Sponsor: Harokopio University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2020-02-24
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-12
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	White bread	100g white bread plus 40ml butter
Control	Butter	100g white bread plus 40ml butter
Refined olive oil	Refined olive oil	100g white bread plus 40ml refined olive oil
EVOO with moderate concentration of oleocanthal	White bread	100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal
Positive control	Ibuprofen	100g white bread plus 40ml butter and 400mg ibuprofen
EVOO with moderate concentration of oleocanthal	EVOO with 250 mg/kg oleocanthal	100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal
Positive control	White bread	100g white bread plus 40ml butter and 400mg ibuprofen
EVOO with high concentration of oleocanthal	EVOO with 500 mg/kg oleocanthal	100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal
Positive control	Butter	100g white bread plus 40ml butter and 400mg ibuprofen
Refined olive oil	White bread	100g white bread plus 40ml refined olive oil
EVOO with high concentration of oleocanthal	White bread	100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal

Primary Outcome Measures

Name	Time	Method
Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption	0 and 240 after the consumption of each type of meal	EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of PAF-induced platelet aggregation at 240 min after meals consumption	0 and 240 after the consumption of each type of meal	EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of TRAP-induced platelet aggregation at 90 min after meals consumption	0 and 90 after the consumption of each type of meal	EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Glucose	0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal	iAUC of postprandial glucose will be calculated by serum glucose levels (mg/dL) which will be assessed by commercially available kits
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Triglycerides	0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal	iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption	0 and 90 after the consumption of each type of meal	EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of TRAP-induced platelet aggregation at 240 min after meals consumption	0 and 240 after the consumption of each type of meal	EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of PAF-induced platelet aggregation at 90 min after meals consumption	0 and 90 after the consumption of each type of meal	EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Insulin	0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal	iAUC of postprandial insulin will be calculated by serum insulin levels (mIU/L) which will be assessed by commercially available kits

Secondary Outcome Measures

Name	Time	Method
Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls	0, 60, 120, 180, 240 min after the consumption of each meal	iAUC of postprandial protein carbonyls will be calculated by plasma protein carbonyl levels (mg/dL) which will be determined by a photometric assay
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6	0, 60, 120, 180, 240 min after the consumption of each meal	iAUC of postprandial IL-6 will be calculated by serum IL-6 levels (mg/dL) which will be assessed by commercially available ELISA kits

Trial Locations

Locations (1)

Department of Nutrition and Dietetics, Harokopio University; 🇬🇷 Athens, I Am Not In The U.S. Or Canada, Greece