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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Extra Virgin Olive Oil (EVOO)
Sponsored by
Makati Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus Type 2, Diet therapy, Extra virgin olive oil

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Initially received the test meal with EVOO, then on crossover, received the meal without EVOO

Initially received the test meal without EVOO, then on crossover, received the meal without EVOO

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2019
Last Updated
August 30, 2019
Sponsor
Makati Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04077216
Brief Title
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients
Official Title
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makati Medical Center

4. Oversight

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

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus Type 2, Diet therapy, Extra virgin olive oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Controlled Crossover trial
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Initially received the test meal with EVOO, then on crossover, received the meal without EVOO
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Initially received the test meal without EVOO, then on crossover, received the meal without EVOO
Intervention Type
Dietary Supplement
Intervention Name(s)
Extra Virgin Olive Oil (EVOO)
Intervention Description
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
Primary Outcome Measure Information:
Title
trans-meal blood glucose
Description
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
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 30-65 years old diagnosed with Type 2 Diabetes Mellitus body mass index under the overweight or obese class I category (by Asia Pacific guidelines) Exclusion Criteria: pregnant patients patients with history of frequent hypoglycemic episodes those at high risk of developing ketoacidosis and hyperglycemic hyperosmolar syndrome those with identified acute stress during the study (illness, fever, trauma leading to hospitalization) current intake of steroids olive oil allergy or intolerance digestive disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jocelyn Capuli-Isidro, MD
Organizational Affiliation
Makati Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ma. Cecilia Gonzales, MD
Organizational Affiliation
Makati Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Marie Macabuag-Oliva, MD
Organizational Affiliation
Makati Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makati Medical Center
City
Makati City
State/Province
NCR
ZIP/Postal Code
1004
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data gathered from this study were treated in conformance with the principles of confidentiality, codes were used in data collection forms and documents accessible only by the primary investigator. Explicit consent for sharing individual participant data was not taken.
Citations:
PubMed Identifier
26148926
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.
Results Reference
background
PubMed Identifier
23432189
Citation
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. Erratum In: N Engl J Med. 2014 Feb 27;370(9):886.
Results Reference
background
PubMed Identifier
26378571
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.
Results Reference
background
PubMed Identifier
26192450
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(7):e172. doi: 10.1038/nutd.2015.23.
Results Reference
background
PubMed Identifier
26861923
Citation
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.
Results Reference
background
PubMed Identifier
18786605
Citation
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.
Results Reference
background
PubMed Identifier
24107659
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.
Results Reference
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Links:
URL
https://www.fnri.dost.gov.ph
Description
2018 Expanded National Nutrition Survey by the Food and Nutrition Research Institute
URL
http://www.internationaloliveoil.org/estaticos/view/222-standards
Description
Trade standard applying to olive oil and olive pomace oil by the International Olive Oil Council (IOC)

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

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