Diabetes Mellitus, Adult-Onset, Platelet Dysfunction, Postprandial Hyperglycemia, Lipidemia, Inflammation, Oxidative Stress
Conditions
Keywords
type 2 diabetes mellitus, diabetic platelet, platelet aggregation, oxidative stress, inflammation, postrpandial, hyperglycemia, extra virgin olive oil, oleocanthal, polyphenols, dyslipidemia
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
OTHERWhite bread
White bread (120g) containing 54 g CHO
OTHERButter
Butter 39 g
OTHERRefined olive oil
Refined olive oil (40 ml).
OTHEREVOO with 250 mg/kg oleocanthal
Extra virgin olive oil containing 250 mg/kg oleocanthal.
OTHEREVOO with 500 mg/kg oleocanthal
Extra virgin olive oil containing 500 mg/kg oleocanthal.
OTHERIbuprofen
Ibuprofen 400 mg
Sponsors
National and Kapodistrian University of Athens
University of Peloponnese
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention model description
Acute postprandial study with a randomized cross-over design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 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 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Contacts
Primary ContactTzortzis Nomikos, PhD
Backup ContactMaria Efthymia Katsa, MSc
Outcome results
None listed