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

August 30, 2019 updated by: Daphne Gayle P Galang, Makati Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • NCR
      • Makati City, NCR, Philippines, 1004
        • Makati Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Initially received the test meal with EVOO, then on crossover, received the meal without EVOO
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
No Intervention: Group B
Initially received the test meal without EVOO, then on crossover, received the meal without EVOO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makati Medical Center

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MakatiMedCtr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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