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

N/AUnknownNCT04419948

Harokopio University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Adult-Onset Platelet Dysfunction

Interventions

White breadOTHER

White bread (120g) containing 54 g CHO

ButterOTHER

Butter 39 g

Refined olive oilOTHER

Refined olive oil (40 ml).

EVOO with 250 mg/kg oleocanthalOTHER

Extra virgin olive oil containing 250 mg/kg oleocanthal.

EVOO with 500 mg/kg oleocanthalOTHER

Extra virgin olive oil containing 500 mg/kg oleocanthal.

IbuprofenOTHER

Ibuprofen 400 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption

EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 90 after the consumption of each type of meal

Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption

EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 240 after the consumption of each type of meal

Change from baseline of TRAP-induced platelet aggregation at 90 min after meals consumption

EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 90 after the consumption of each type of meal

Change from baseline of TRAP-induced platelet aggregation at 240 min after meals consumption

EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 240 after the consumption of each type of meal

Change from baseline of PAF-induced platelet aggregation at 90 min after meals consumption

EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 90 after the consumption of each type of meal

Change from baseline of PAF-induced platelet aggregation at 240 min after meals consumption

EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry

Time frame: 0 and 240 after the consumption of each type of meal

Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Glucose

iAUC of postprandial glucose will be calculated by serum glucose levels (mg/dL) which will be assessed by commercially available kits

Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal

Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Insulin

iAUC of postprandial insulin will be calculated by serum insulin levels (mIU/L) which will be assessed by commercially available kits

Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal

Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Triglycerides

iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits

Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal

Secondary Outcomes

Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6

iAUC of postprandial IL-6 will be calculated by serum IL-6 levels (mg/dL) which will be assessed by commercially available ELISA kits

Time frame: 0, 60, 120, 180, 240 min after the consumption of each meal

Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls

iAUC of postprandial protein carbonyls will be calculated by plasma protein carbonyl levels (mg/dL) which will be determined by a photometric assay

Time frame: 0, 60, 120, 180, 240 min after the consumption of each meal

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts