Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077216
• Other study ID #: MakatiMedCtr
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2019
• Source: Makati Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes Mellitus Filipino patients has not been studied. The investigators aimed to determine whether a significant difference exists in meals containing EVOO versus meals without EVOO among Type 2 Diabetes Mellitus patients.

Thirteen patients were included in this randomized controlled cross-over trial. They were randomized to receive a meal with or without EVOO followed by a one week wash out period, where they were given the other intervention. The primary outcome is the trans-meal blood glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.

Description:

During their first visit, the participants were oriented on the conduct of the study. They were advised to be compliant with their medications throughout the duration of the trial.

On their second visit, participants were asked to do a six to eight-hour overnight fast, and their fasting blood sugar was drawn. Serum samples were analyzed through the hexokinase method. The participants were then randomly allocated (first allocation) by the dietician through a coin toss to receive a standard breakfast without EVOO or a meal admixed with one tablespoon of EVOO. The standard meals were labeled with serial numbers, and both the participants and the investigator were blinded to the intervention. The meals were consumed steadily in 15 to 20 minutes, after which, the food containers were collected to ensure its full consumption. Breakfast was chosen in order to avoid a second meal bias. The participants were asked to sit in the waiting area of the laboratory until the 2-hour postprandial blood sugar was due to be drawn.

After a one-week washout period, the participants were asked to come back for a cross over to the other treatment arm (second allocation). The participants were given the same test meal to ensure that that the glycemic index of the food remained constant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. patients aged 30-65 years old

2. diagnosed with Type 2 Diabetes Mellitus

3. body mass index under the overweight or obese class I category (by Asia Pacific guidelines)

Exclusion Criteria:

1. pregnant patients

2. patients with history of frequent hypoglycemic episodes

3. those at high risk of developing ketoacidosis and hyperglycemic hyperosmolar syndrome

4. those with identified acute stress during the study (illness, fever, trauma leading to hospitalization)

5. current intake of steroids

6. olive oil allergy or intolerance

7. digestive disorders

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Extra Virgin Olive Oil (EVOO)
This study used the FDA approved Doña Elena Extra virgin olive oil, which is readily available in local supermarkets. Its free acidity expressed as oleic acid was found to be 0.26%, comparable with the International food standards.15

Locations

Country	Name	City	State
Philippines	Makati Medical Center	Makati City	NCR

Sponsors (1)

Lead Sponsor	Collaborator
Makati Medical Center

Country where clinical trial is conducted

Philippines, 

References & Publications (7)

Bozzetto L, Alderisio A, Giorgini M, Barone F, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Extra-Virgin Olive Oil Reduces Glycemic Response to a High-Glycemic Index Meal in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2016 Apr;39(4):518-24. doi: 10.2337/dc15-2189. Epub 2016 Feb 9. — View Citation

Buckland G, Gonzalez CA. The role of olive oil in disease prevention: a focus on the recent epidemiological evidence from cohort studies and dietary intervention trials. Br J Nutr. 2015 Apr;113 Suppl 2:S94-101. doi: 10.1017/S0007114514003936. Review. — View Citation

Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25. Erratum in: N Engl J Med. 2014 Feb 27;370(9):886. Corrected and republished in: N Engl J Med. 2018 Jun 21;378(25):e34. Retraction in: N Engl J Med. 2018 Jun 21;378(25):2441-2442. — View Citation

Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr; American Diabetes Association. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2013 Nov;36(11):3821-42. doi: 10.2337/dc13-2042. Epub 2013 Oct 9. — View Citation

Holst JJ, Vilsbøll T, Deacon CF. The incretin system and its role in type 2 diabetes mellitus. Mol Cell Endocrinol. 2009 Jan 15;297(1-2):127-36. doi: 10.1016/j.mce.2008.08.012. Epub 2008 Aug 20. Review. — View Citation

Schwingshackl L, Christoph M, Hoffmann G. Effects of Olive Oil on Markers of Inflammation and Endothelial Function-A Systematic Review and Meta-Analysis. Nutrients. 2015 Sep 11;7(9):7651-75. doi: 10.3390/nu7095356. Review. — View Citation

Violi F, Loffredo L, Pignatelli P, Angelico F, Bartimoccia S, Nocella C, Cangemi R, Petruccioli A, Monticolo R, Pastori D, Carnevale R. Extra virgin olive oil use is associated with improved post-prandial blood glucose and LDL cholesterol in healthy subjects. Nutr Diabetes. 2015 Jul 20;5:e172. doi: 10.1038/nutd.2015.23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	trans-meal blood glucose	percent change in 2-hour postprandial blood glucose. This was calculated as the fasting blood sugar subtracted from the 2-hour postprandial glucose divided by the fasting blood sugar multiplied by 100	2 hours

External Links

•   2018 Expanded National Nutrition Survey by the Food and Nutrition Research Institute
•   Trade standard applying to olive oil and olive pomace oil by the International Olive Oil Council (IOC)