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Nonapeptide-1

Melanostatine-5, White 05

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Studies 4
Trials 100
Unknown NA INTERVENTIONAL NCT04419948

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: White bread
Type: OTHER
Description: White bread (120g) containing 54 g CHO
Name: Butter
Type: OTHER
Description: Butter 39 g
Name: Refined olive oil
Type: OTHER
Description: Refined olive oil (40 ml).
Name: EVOO with 250 mg/kg oleocanthal
Type: OTHER
Description: Extra virgin olive oil containing 250 mg/kg oleocanthal.
Name: EVOO with 500 mg/kg oleocanthal
Type: OTHER
Description: Extra virgin olive oil containing 500 mg/kg oleocanthal.
Name: Ibuprofen
Type: OTHER
Description: Ibuprofen 400 mg

Primary Outcomes

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

Trial Information

NCT ID

NCT04419948

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Harokopio University

Last Updated

December 15, 2025