Diabetes Mellitus, Type 2NCT04077216
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients
A study testing Extra Virgin Olive Oil (EVOO) in people with Diabetes Mellitus, Type 2, run by Makati Medical Center at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Extra Virgin Olive Oil (EVOO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Sep 2018to 30 Nov 2018
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Extra Virgin Olive Oil (EVOO)
- Keywords
- Diabetes Mellitus Type 2, Diet therapy, Extra virgin olive oil
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive Oil (EVOO)Dietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Initially received the test meal with EVOO, then on crossover, received the meal without EVOO Receives: Dietary Supplement: Extra Virgin Olive Oil (EVOO) |
| Group B | No intervention | Initially received the test meal without EVOO, then on crossover, received the meal without EVOO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Controlled Crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makati Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Gayle P Galang, Makati Medical Center
- Investigators
- Maria Jocelyn Capuli-Isidro, MD, Principal investigator, Makati Medical CenterMa. Cecilia Gonzales, MD, Principal investigator, Makati Medical CenterAndrea Marie Macabuag-Oliva, MD, Principal investigator, Makati Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077216
- Sponsor's protocol ID
- MakatiMedCtr
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26148926Estruch 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.
PubMed 23432189Schwingshackl 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.
PubMed 26378571Violi 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.
PubMed 26192450Bozzetto 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.
PubMed 26861923Holst 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.
PubMed 18786605Evert 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.
PubMed 24107659
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04077216
- Acronym / sponsor ID
- MakatiMedCtr
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus Type 2, Diet therapy, Extra virgin olive oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Makati Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Sep 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Crossover trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Extra Virgin Olive Oil (EVOO)Initially received the test meal with EVOO, then on crossover, received the meal without EVOO |
| Group B | No intervention | –Initially received the test meal without EVOO, then on crossover, received the meal without EVOO |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| 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 | Dietary supplement | Group A |
Primary outcome
trans-meal blood glucose
Time frame: 2 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 26148926Buckland 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.
- Background: PubMed 23432189Estruch 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.
- Background: PubMed 26378571Schwingshackl 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.
- Background: PubMed 26192450Violi 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.
- Background: PubMed 26861923Bozzetto 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.
- Background: PubMed 18786605Holst 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.
- Background: PubMed 24107659Evert 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.
- 2018 Expanded National Nutrition Survey by the Food and Nutrition Research InstituteLink provided by the sponsor.
- Trade standard applying to olive oil and olive pomace oil by the International Olive Oil Council (IOC)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Maria Jocelyn Capuli-Isidro, MD principal investigator
Makati Medical Center
Ma. Cecilia Gonzales, MD principal investigator
Makati Medical Center
Andrea Marie Macabuag-Oliva, MD principal investigator
Makati Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra Virgin Olive Oil (EVOO) in people with Diabetes Mellitus, Type 2, run by Makati Medical Center at 1 site in Philippines.
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 3 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: finished, as of the sponsor's last update on 4 Sep 2019. 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 Philippines. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trans-meal blood glucose (time frame: 2 hours). 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 NCT04077216, which also lists 7 linked publications.
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 4 Sep 2019.