Clinical trial NCT04419948: Oleocanthal Rich Olive Oil Acute Effects on Hyperglycemia and Platelet Activation in T2DM
Official title: Acute Effect of Oleocanthal Rich Extra-virgin Olive Oil on Postpranial Hyperglycemia and Platelet Activation of T2DM Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Adult-Onset
Platelet Dysfunction
Postprandial Hyperglycemia
Lipidemia
Inflammation
Oxidative Stress
Keywords: type 2 diabetes mellitus
diabetic platelet
platelet aggregation
oxidative stress
inflammation
postrpandial
hyperglycemia
extra virgin olive oil
oleocanthal
polyphenols
dyslipidemia
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: University of Peloponnese
First posted: 2020-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute postprandial study with a randomized cross-over design
Primary purpose: OTHER

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.


Eligibility criteria: 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

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
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
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
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
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
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
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
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
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
Secondary outcomes:
measure: Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6
timeFrame: 0, 60, 120, 180, 240 min after the consumption of each meal
measure: Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls
timeFrame: 0, 60, 120, 180, 240 min after the consumption of each meal
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition and Dietetics, Harokopio University
state: I Am Not In The U.S. Or Canada
Study officials:
References:
citation: 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.