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

Center for Pharmacological and Botanical Research

Status: Completed

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Extra Virgin Olive Oil Addition

Study type: Interventional

Funder types: Other

Identifiers

NCT05120388

11012021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Dietary addition of extra virgin olive oil

Experimental group

Description:

WHO diet with a daily addition of extra virgin olive oil

Treatment:

Dietary Supplement: Extra Virgin Olive Oil Addition

No addition of extra virgin Olive Oil

No Intervention group

Description:

WHO diet