NCT05120388

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Center for Pharmacological and Botanical Research · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extra Virgin Olive Oil Addition	Daily dietary addition of olive oil (three tablespoons)

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-04-15
• Completion: 2024-08-19
• First posted: 2021-11-15
• Last updated: 2024-08-20

Locations

1 site across 1 country: Argentina