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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-08-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Data analysis will be masked

Study Groups

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Dietary addition of extra virgin olive oil

WHO diet with a daily addition of extra virgin olive oil

Group Type EXPERIMENTAL

Extra Virgin Olive Oil Addition

Intervention Type DIETARY_SUPPLEMENT

Daily dietary addition of olive oil (three tablespoons)

No addition of extra virgin Olive Oil

WHO diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extra Virgin Olive Oil Addition

Daily dietary addition of olive oil (three tablespoons)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)