Randomized controlled trial2017Open access

A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study

Assaf-Balut C, García de la Torre N, Durán A, Fuentes M, Bordiú E, Del Valle L, Familiar C, Ortolá A, Jiménez I, Herraiz MA, Izquierdo N, Perez N, Torrejon MJ, Ortega MI, Illana FJ, Runkle I, de Miguel MP, Montañez C, Barabash A, Cuesta M, Rubio MA, Calle-Pascual AL

PloS one · 173 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death
Intake measured by
Food frequency questionnaire

Who paid for it

Funding
Independent funding
Nonprofit
American Diabetes Association
Government
Instituto de Salud Carlos III
Government
European Regional Development Fund
University or hospital
IdISSC Hospital Clinico San Carlos
Nonprofit
Fundación para Estudios Endocrinometabolicos
Grants
Instituto de Salud Carlos III (PI14/01563); Instituto de Salud Carlos III (PI14/)

Based on 5 listed funder(s) and full-text disclosure statement.

Publication

Published
2017-10-19 · PLoS One · vol. 12 · issue 10 · p. e0185873
Publisher
Public Library of Science
Cited
235 citations · more than 99% of similar papers · 12.6× the field average
Impact
Top 10% most cited in its field
References
37 works
Access
Open access (journal) · CC-BY
Research areas
Gestational Diabetes Research and Management · Pregnancy and preeclampsia studies · Birth, Development, and Health
Keywords
Gestational diabetes, Medicine, Obstetrics, Pregnancy, Incidence (geometry), Randomized controlled trial, Mediterranean diet, Diabetes mellitus, Caesarean section, Internal medicine, Gestation, Endocrinology, Biology
MeSH
humans, pistacia, diabetes, gestational, pregnancy outcome, incidence, prospective studies, life style, diet, mediterranean, pregnancy, adult, infant, newborn, female, olive oil

22 authors

From ES

  • Carla Assaf-BalutUniversidad Complutense de Madrid; Hospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos
  • Nuria García de la TorreHospital Clínico San Carlos; Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos
  • Alejandra DuránUniversidad Complutense de Madrid; Hospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos
  • Manuel Enrique FuentesInstituto de Investigación Sanitaria del Hospital Clínico San Carlos
  • Elena BordiúUniversidad Complutense de Madrid; Hospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos
  • Laura del ValleHospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos

Abstract

Background

Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied.

Methods

We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8-12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24-28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat.

Results

A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56-0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57-0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24-28 and 36-38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05).

Conclusions

An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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