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

Inflammation Clinical Trial

Official title:

Acute Effect of Oleocanthal Rich Extra-virgin Olive Oil on Postpranial Hyperglycemia and Platelet Activation of T2DM Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419948
• Other study ID #: 79549/16-05-2019
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: July 2021

Study information

• Verified date: June 2020
• Source: Harokopio University
• Contact: Tzortzis Nomikos, PhD
• Phone: 00302109358920
• Email: tnomikos72[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult-Onset
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Hyperlipidemias
• Inflammation
• Lipidemia
• Oxidative Stress
• Platelet Dysfunction
• Postprandial Hyperglycemia

Intervention

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

Locations

Country	Name	City	State
Greece	Department of Nutrition and Dietetics, Harokopio University	Athens	I Am Not In The U.S. Or Canada

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens, University of Peloponnese

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	0 and 240 after the consumption of each type of meal
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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	0, 60, 120, 180, 240 min after the consumption of each meal