NCT04077216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

August 29, 2019

Last Update Submit

August 30, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2Diet therapyExtra virgin olive oil

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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

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

Interventions

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

Group A

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makati Medical Center

Makati City, NCR, 1004, Philippines

Location

Related Publications (7)

  • 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.

    PMID: 26148926BACKGROUND

  • 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.

    PMID: 23432189BACKGROUND

  • 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.

    PMID: 26378571BACKGROUND

  • 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.

    PMID: 26192450BACKGROUND

  • 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.

    PMID: 26861923BACKGROUND

  • 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.

    PMID: 18786605BACKGROUND

  • 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.

    PMID: 24107659BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Maria Jocelyn Capuli-Isidro, MD

    Makati Medical Center

    PRINCIPAL INVESTIGATOR

  • Ma. Cecilia Gonzales, MD

    Makati Medical Center

    PRINCIPAL INVESTIGATOR

  • Andrea Marie Macabuag-Oliva, MD

    Makati Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized Controlled Crossover trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Section of Endocrinology, Department of Internal Medicine

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 4, 2019

Study Start

September 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

September 4, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

PH(1)