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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Oxidative Stress; Postprandial Hyperglycemia; Diabetes Mellitus, Adult-Onset; Platelet Dysfunction; Lipidemia
• Intervention / Treatment: Other: White bread; Other: Butter; Other: Ibuprofen; Other: Refined olive oil; Other: EVOO with 250 mg/kg oleocanthal; Other: EVOO with 500 mg/kg oleocanthal

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzortzis Nomikos, PhD; Phone Number: 00302109358920; Email: tnomikos72@gmail.com
• Study Contact Backup: Name: Maria Efthymia Katsa, MSc; Phone Number: 00306977973450; Email: merfykatsa@gmail.com

Study Locations

• Greece
  • I Am Not In The U.S. Or Canada
    • Athens, I Am Not In The U.S. Or Canada, Greece, 17671
      • Recruiting
      • Department of Nutrition and Dietetics, Harokopio University
      • Contact: Tzortzis Nomikos, PhD; Phone Number: 00302109358920; Email: tnomikos@hua.gr
      • Contact: Maria Efthymia Katsa, MSc; Phone Number: Nomikos 00306977973450; Email: tnomikos72@gmail.com
      • Principal Investigator: Tzortzis Nomikos, PhD
      • Sub-Investigator: Maria Efthymia Katsa, MSc
      • Sub-Investigator: Kleopatra Ketselidi, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; 100g white bread plus 40ml butter	Other: White bread; White bread (120g) containing 54 g CHO; Other: Butter; Butter 39 g
Experimental: Positive control; 100g white bread plus 40ml butter and 400mg ibuprofen	Other: White bread; White bread (120g) containing 54 g CHO; Other: Butter; Butter 39 g; Other: Ibuprofen; Ibuprofen 400 mg
Experimental: Refined olive oil; 100g white bread plus 40ml refined olive oil	Other: White bread; White bread (120g) containing 54 g CHO; Other: Refined olive oil; Refined olive oil (40 ml).
Experimental: EVOO with moderate concentration of oleocanthal; 100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal	Other: White bread; White bread (120g) containing 54 g CHO; Other: EVOO with 250 mg/kg oleocanthal; Extra virgin olive oil containing 250 mg/kg oleocanthal.
Experimental: EVOO with high concentration of oleocanthal; 100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal	Other: White bread; White bread (120g) containing 54 g CHO; Other: EVOO with 500 mg/kg oleocanthal; Extra virgin olive oil containing 500 mg/kg oleocanthal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens; University of Peloponnese

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: platelet aggregation; type 2 diabetes mellitus; inflammation; oxidative stress; polyphenols; hyperglycemia; dyslipidemia; extra virgin olive oil; diabetic platelet; postrpandial; oleocanthal
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Hyperlipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 79549/16-05-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No