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

NCT04419948 | Unknown

• 1 other identifier: 79549/16-05-2019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• 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

• 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

Study Arms (5)

Control

EXPERIMENTAL

100g white bread plus 40ml butter

Other: White bread; Other: Butter

Positive control

EXPERIMENTAL

100g white bread plus 40ml butter and 400mg ibuprofen

Other: White bread; Other: Butter; Other: Ibuprofen

Refined olive oil

EXPERIMENTAL

100g white bread plus 40ml refined olive oil

Other: White bread; Other: Refined olive oil

EVOO with moderate concentration of oleocanthal

EXPERIMENTAL

100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal

Other: White bread; Other: EVOO with 250 mg/kg oleocanthal

EVOO with high concentration of oleocanthal

EXPERIMENTAL

100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal

Other: White bread; Other: EVOO with 500 mg/kg oleocanthal

Interventions

White bread OTHER

White bread (120g) containing 54 g CHO

Control; EVOO with high concentration of oleocanthal; EVOO with moderate concentration of oleocanthal; Positive control; Refined olive oil

Butter OTHER

Butter 39 g

Control; Positive control

Refined olive oil OTHER

Refined olive oil (40 ml).

Refined olive oil

EVOO with 250 mg/kg oleocanthal OTHER

Extra virgin olive oil containing 250 mg/kg oleocanthal.

EVOO with moderate concentration of oleocanthal

EVOO with 500 mg/kg oleocanthal OTHER

Extra virgin olive oil containing 500 mg/kg oleocanthal.

EVOO with high concentration of oleocanthal

Ibuprofen OTHER

Ibuprofen 400 mg

Positive control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients diagnosed with T2DM
• stable weight the last two months
• smokers or not
• no restriction regarding the menopause

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator
• University of Peloponnese: collaborator

Study Sites (1)

Department of Nutrition and Dietetics, Harokopio University

Athens, I Am Not in the U.S. Or Canada, 17671, Greece

RECRUITING

Related 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.

  PMID: 29904393 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hyperlipidemias; Inflammation; Dyslipidemias

Interventions

Butter; oleocanthal; Ibuprofen

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Tzortzis Nomikos, PhD

CONTACT

00302109358920; tnomikos72@gmail.com

Maria Efthymia Katsa, MSc

CONTACT

00306977973450; merfykatsa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biochemistry

Model Details: Acute postprandial study with a randomized cross-over design

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: June 9, 2020
• Study Start: May 16, 2019
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)