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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
| University of Peloponnese | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | 100g white bread plus 40ml butter |
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| Positive control | Experimental | 100g white bread plus 40ml butter and 400mg ibuprofen |
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| Refined olive oil | Experimental | 100g white bread plus 40ml refined olive oil |
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| EVOO with moderate concentration of oleocanthal | Experimental | 100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal |
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| EVOO with high concentration of oleocanthal | Experimental | 100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White bread | Other | White bread (120g) containing 54 g CHO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzortzis Nomikos, PhD | Contact | 00302109358920 | tnomikos72@gmail.com | |
| Maria Efthymia Katsa, MSc | Contact | 00306977973450 | merfykatsa@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Dietetics, Harokopio University | Recruiting | Athens | I Am Not in the U.S. Or Canada | 17671 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29904393 | Background | Agrawal K, Melliou E, Li X, Pedersen TL, Wang SC, Magiatis P, Newman JW, Holt RR. Oleocanthal-rich extra virgin olive oil demonstrates acute anti-platelet effects in healthy men in a randomized trial. J Funct Foods. 2017 Sep;36:84-93. doi: 10.1016/j.jff.2017.06.046. Epub 2017 Jul 3. |
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Acute postprandial study with a randomized cross-over design
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| Butter | Other | Butter 39 g |
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| Refined olive oil | Other | Refined olive oil (40 ml). |
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| EVOO with 250 mg/kg oleocanthal | Other | Extra virgin olive oil containing 250 mg/kg oleocanthal. |
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| EVOO with 500 mg/kg oleocanthal | Other | Extra virgin olive oil containing 500 mg/kg oleocanthal. |
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| Ibuprofen | Other | Ibuprofen 400 mg |
|
| 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 | 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 | 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 | 0, 15, 30, 60, 90 120, 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 |
| 0, 60, 120, 180, 240 min after the consumption of each meal |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D006949 | Hyperlipidemias |
| D007249 | Inflammation |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002079 | Butter |
| C503534 | oleocanthal |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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