Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04419948
Other study ID # 79549/16-05-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect