Diabetes Mellitus, Adult-OnsetNCT04419948
Oleocanthal Rich Olive Oil Acute Effects on Hyperglycemia and Platelet Activation in T2DM
A study testing White bread, Butter and Refined olive oil in people with Diabetes Mellitus, Adult-Onset and Platelet Dysfunction, run by Harokopio University at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Adult-Onset, Platelet Dysfunction, Postprandial Hyperglycemia
- What is being tested?
- White bread, Butter and Refined olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 16 May 2019to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients diagnosed with T2DM
- stable weight the last two months
- smokers or not
- no restriction regarding the menopause
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Nutrition and Dietetics, Harokopio University
Athens, I Am Not in the U.S. Or Canada, 17671
Tzortzis Nomikos, PhD, 00302109358920, tnomikos@hua.gr
Maria Efthymia Katsa, MSc, 00306977973450 ext. Nomikos, tnomikos72@gmail.com
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Adult-Onset, Platelet Dysfunction, Postprandial Hyperglycemia, Lipidemia, Inflammation, Oxidative Stress
- Being tested
- White bread, Butter, Refined olive oil, EVOO with 250 mg/kg oleocanthal, EVOO with 500 mg/kg oleocanthal
- Keywords
- type 2 diabetes mellitus, diabetic platelet, platelet aggregation, oxidative stress, inflammation, postrpandial, hyperglycemia, extra virgin olive oil, oleocanthal, polyphenols, dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hyperlipidemias, Inflammation, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White breadOther
White bread (120g) containing 54 g CHO
ButterOther
Butter 39 g
Refined olive oilOther
Refined olive oil (40 ml).
EVOO with 250 mg/kg oleocanthalOther
Extra virgin olive oil containing 250 mg/kg oleocanthal.
EVOO with 500 mg/kg oleocanthalOther
Extra virgin olive oil containing 500 mg/kg oleocanthal.
IbuprofenOther
Ibuprofen 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 100g white bread plus 40ml butter Receives: Other: White bread; Other: Butter |
| Positive control | Experimental | 100g white bread plus 40ml butter and 400mg ibuprofen Receives: Other: White bread; Other: Butter; Other: Ibuprofen |
| Refined olive oil | Experimental | 100g white bread plus 40ml refined olive oil Receives: 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 Receives: 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 Receives: Other: White bread; Other: EVOO with 500 mg/kg oleocanthal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
iAUC of postprandial IL-6 will be calculated by serum IL-6 levels (mg/dL) which will be assessed by commercially available ELISA kits
Measured: 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
Measured: 0, 60, 120, 180, 240 min after the consumption of each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start16 May 2019
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Adult-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute postprandial study with a randomized cross-over design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Peloponnese
- Responsible party
- Principal investigator, Tzortzis Nomikos, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419948
- Sponsor's protocol ID
- 79549/16-05-2019
- Status last verified
- Jun 2020
- First submitted
- 24 Feb 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29904393
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Oleocanthal Rich Extra-virgin Olive Oil on Postpranial Hyperglycemia and Platelet Activation of T2DM Patients
- ClinicalTrials.gov ID
- NCT04419948
- Acronym / sponsor ID
- 79549/16-05-2019
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Peloponnese
- Study start
- 16 May 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Acute postprandial study with a randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: White bread, Other: Butter100g white bread plus 40ml butter |
| Positive control | Experimental | Other: White bread, Other: Butter, Other: Ibuprofen100g white bread plus 40ml butter and 400mg ibuprofen |
| Refined olive oil | Experimental | Other: White bread, Other: Refined olive oil100g white bread plus 40ml refined olive oil |
| EVOO with moderate concentration of oleocanthal | Experimental | Other: White bread, Other: EVOO with 250 mg/kg oleocanthal100g white bread plus 40ml EVOO containing 250 mg/kg oleocanthal |
| EVOO with high concentration of oleocanthal | Experimental | Other: White bread, Other: EVOO with 500 mg/kg oleocanthal100g white bread plus 40ml EVOO containing 500 mg/kg oleocanthal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients diagnosed with T2DM
- stable weight the last two months
- smokers or not
- no restriction regarding the menopause
Key exclusion criteria (7 listed)
- insulin therapy
- antiplatelet, anti-coagulant, anti-inflammatory and anti-depressant medication
- chronic inflammatory disease
- autoimmune diseases
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White breadWhite bread (120g) containing 54 g CHO | Other | Control, EVOO with high concentration of oleocanthal, EVOO with moderate concentration of oleocanthal, Positive control, Refined olive oil |
| ButterButter 39 g | Other | Control, Positive control |
| Refined olive oilRefined olive oil (40 ml). | Other | Refined olive oil |
| EVOO with 250 mg/kg oleocanthalExtra virgin olive oil containing 250 mg/kg oleocanthal. | Other | EVOO with moderate concentration of oleocanthal |
| EVOO with 500 mg/kg oleocanthalExtra virgin olive oil containing 500 mg/kg oleocanthal. | Other | EVOO with high concentration of oleocanthal |
| IbuprofenIbuprofen 400 mg | Other | Positive control |
Primary outcome
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption
Time frame: 0 and 90 after the consumption of each type of meal
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
Time frame: 0 and 240 after the consumption of each type of meal
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
Time frame: 0 and 90 after the consumption of each type of meal
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
Time frame: 0 and 240 after the consumption of each type of meal
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
Time frame: 0 and 90 after the consumption of each type of meal
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
Time frame: 0 and 240 after the consumption of each type of meal
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
Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
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
Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
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
Time frame: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits
2 secondary outcomes
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6
Time frame: 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
Time frame: 0, 60, 120, 180, 240 min after the consumption of each meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 29904393Agrawal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White bread, Butter and Refined olive oil in people with Diabetes Mellitus, Adult-Onset and Platelet Dysfunction, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzortzis Nomikos, PhD (00302109358920, tnomikos72@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption (time frame: 0 and 90 after the consumption of each type of meal). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.