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

C

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

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

Trial contacts and locations

1

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Central trial contact

Alicia Jawerbaum, PhD

Data sourced from clinicaltrials.gov

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