Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients
NCT ID: NCT04077216
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2018-09-01
2018-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A
Initially received the test meal with EVOO, then on crossover, received the meal without EVOO
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
Group B
Initially received the test meal without EVOO, then on crossover, received the meal without EVOO
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
65 Years
ALL
No
Sponsors
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Makati Medical Center
OTHER
Responsible Party
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Daphne Gayle P Galang
Fellow, Section of Endocrinology, Department of Internal Medicine
Principal Investigators
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Maria Jocelyn Capuli-Isidro, MD
Role: PRINCIPAL_INVESTIGATOR
Makati Medical Center
Ma. Cecilia Gonzales, MD
Role: PRINCIPAL_INVESTIGATOR
Makati Medical Center
Andrea Marie Macabuag-Oliva, MD
Role: PRINCIPAL_INVESTIGATOR
Makati Medical Center
Locations
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Makati Medical Center
Makati City, NCR, Philippines
Countries
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References
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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.
Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez 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.
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.
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(7):e172. doi: 10.1038/nutd.2015.23.
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.
Holst JJ, Vilsboll 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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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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)
Other Identifiers
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MakatiMedCtr
Identifier Type: -
Identifier Source: org_study_id
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