Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG) (OLIDIAG)

September 15, 2023 updated by: Center for Pharmacological and Botanical Research
Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.

Study Type

Interventional

Enrollment (Estimated)

1200

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 Contact

Study Locations

  • Argentina
    • Neuquen
      • Neuquén, Neuquen, Argentina, Q8300BCI
        • Recruiting
        • Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo
        • Contact:

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa > 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose > 140 mg/dl)

Exclusion Criteria:

  • Multiple pregnancy
  • Pregestational diabetes (type 1 or type 2)
  • Bariatric surgery
  • Infectious diseases

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary addition of extra virgin olive oil
WHO diet with a daily addition of extra virgin olive oil
Dietary supplement: Extra Virgin Olive Oil Addition
Daily dietary addition of olive oil (three tablespoons)
No Intervention: No addition of extra virgin Olive Oil
WHO diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal triglyceridemia
Time Frame: term pregnancy
triglycerides in mg/dl
term pregnancy
maternal weight gain
Time Frame: change from prepregnancy weight to term pregnancy weight
gestational maternal weight gain in kg
change from prepregnancy weight to term pregnancy weight
number of participants with insulin requirement
Time Frame: term pregnancy
insulin use
term pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with diabetes at postpartum
Time Frame: six weeks postpartum
maternal diagnosis of diabetes at postpartum
six weeks postpartum

Collaborators and Investigators

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

Sponsor

Center for Pharmacological and Botanical Research

Collaborators

Sociedad Argentina de Diabetes

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)

January 11, 2022

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11012021

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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