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

Primary Purpose

Diabetes Mellitus, Adult-Onset, Platelet Dysfunction, Postprandial Hyperglycemia

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
White bread
Butter
Refined olive oil
EVOO with 250 mg/kg oleocanthal
EVOO with 500 mg/kg oleocanthal
Ibuprofen
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Adult-Onset focused on measuring type 2 diabetes mellitus, diabetic platelet, platelet aggregation, oxidative stress, inflammation, postrpandial, hyperglycemia, extra virgin olive oil, oleocanthal, polyphenols, dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nutrition and Dietetics, Harokopio UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Positive control

Refined olive oil

EVOO with moderate concentration of oleocanthal

EVOO with high concentration of oleocanthal

Arm Description

100g white bread plus 40ml butter

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

100g white bread plus 40ml refined olive oil

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 24, 2020
Last Updated
June 3, 2020
Sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens, University of Peloponnese
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1. Study Identification

Unique Protocol Identification Number
NCT04419948
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens, University of Peloponnese

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Acute postprandial study with a randomized cross-over design
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
100g white bread plus 40ml butter
Arm Title
Positive control
Arm Type
Experimental
Arm Description
100g white bread plus 40ml butter and 400mg ibuprofen
Arm Title
Refined olive oil
Arm Type
Experimental
Arm Description
100g white bread plus 40ml refined olive oil
Arm Title
EVOO with moderate concentration of oleocanthal
Arm Type
Experimental
Arm Description
100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal
Arm Title
EVOO with high concentration of oleocanthal
Arm Type
Experimental
Arm Description
100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal
Intervention Type
Other
Intervention Name(s)
White bread
Intervention Description
White bread (120g) containing 54 g CHO
Intervention Type
Other
Intervention Name(s)
Butter
Intervention Description
Butter 39 g
Intervention Type
Other
Intervention Name(s)
Refined olive oil
Intervention Description
Refined olive oil (40 ml).
Intervention Type
Other
Intervention Name(s)
EVOO with 250 mg/kg oleocanthal
Intervention Description
Extra virgin olive oil containing 250 mg/kg oleocanthal.
Intervention Type
Other
Intervention Name(s)
EVOO with 500 mg/kg oleocanthal
Intervention Description
Extra virgin olive oil containing 500 mg/kg oleocanthal.
Intervention Type
Other
Intervention Name(s)
Ibuprofen
Intervention Description
Ibuprofen 400 mg
Primary Outcome Measure Information:
Title
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption
Description
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 90 after the consumption of each type of meal
Title
Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption
Description
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 240 after the consumption of each type of meal
Title
Change from baseline of TRAP-induced platelet aggregation at 90 min after meals consumption
Description
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 90 after the consumption of each type of meal
Title
Change from baseline of TRAP-induced platelet aggregation at 240 min after meals consumption
Description
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 240 after the consumption of each type of meal
Title
Change from baseline of PAF-induced platelet aggregation at 90 min after meals consumption
Description
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 90 after the consumption of each type of meal
Title
Change from baseline of PAF-induced platelet aggregation at 240 min after meals consumption
Description
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Time Frame
0 and 240 after the consumption of each type of meal
Title
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Glucose
Description
iAUC of postprandial glucose will be calculated by serum glucose levels (mg/dL) which will be assessed by commercially available kits
Time Frame
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
Title
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Insulin
Description
iAUC of postprandial insulin will be calculated by serum insulin levels (mIU/L) which will be assessed by commercially available kits
Time Frame
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
Title
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Triglycerides
Description
iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits
Time Frame
0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
Secondary Outcome Measure Information:
Title
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6
Description
iAUC of postprandial IL-6 will be calculated by serum IL-6 levels (mg/dL) which will be assessed by commercially available ELISA kits
Time Frame
0, 60, 120, 180, 240 min after the consumption of each meal
Title
Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls
Description
iAUC of postprandial protein carbonyls will be calculated by plasma protein carbonyl levels (mg/dL) which will be determined by a photometric assay
Time Frame
0, 60, 120, 180, 240 min after the consumption of each meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzortzis Nomikos, PhD
Phone
00302109358920
Email
tnomikos72@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Efthymia Katsa, MSc
Phone
00306977973450
Email
merfykatsa@gmail.com
Facility Information:
Facility Name
Department of Nutrition and Dietetics, Harokopio University
City
Athens
State/Province
I Am Not In The U.S. Or Canada
ZIP/Postal Code
17671
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzortzis Nomikos, PhD
Phone
00302109358920
Email
tnomikos@hua.gr
First Name & Middle Initial & Last Name & Degree
Maria Efthymia Katsa, MSc
Phone
00306977973450
Ext
Nomikos
Email
tnomikos72@gmail.com
First Name & Middle Initial & Last Name & Degree
Tzortzis Nomikos, PhD
First Name & Middle Initial & Last Name & Degree
Maria Efthymia Katsa, MSc
First Name & Middle Initial & Last Name & Degree
Kleopatra Ketselidi, Bachelor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29904393
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.
Results Reference
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Oleocanthal Rich Olive Oil Acute Effects on Hyperglycemia and Platelet Activation in T2DM

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