Efficacy of Fish Oil and/or Probiotic Intervention on the Incidence of Gestational Diabetes Mellitus in an At-Risk Group of Overweight and Obese Women: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Pellonperä O, Mokkala K, Houttu N, Vahlberg T, Koivuniemi E, Tertti K, Rönnemaa T, Laitinen K
Diabetes care · 123 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Independent funding
- Nonprofit
- Suomen Lääketieteen Säätiö
- Nonprofit
- Fondazione Diabete Ricerca
- Government
- Academy of Finland
- Nonprofit
- Juho Vainion Säätiö
- Government
- Business Finland
- Nonprofit
- The Finnish Medical Foundation
- Government
- state research funding for university-level health research of the Turku University Hospital Expert Responsibility Area
- Nonprofit
- Diabetes Research Foundation
- Nonprofit
- Juho Vainio Foundation
- Grants
- Academy of Finland (#258606); Business Finland (#3486/31/2015)
Based on 9 listed funder(s).
Publication
- Published
- 2019-04-09 · Diabetes Care · vol. 42 · issue 6 · pp. 1009–1017
- Publisher
- American Diabetes Association
- Cited
- 145 citations · more than 99% of similar papers · 14.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 46 works
- Access
- Paywalled
- Research areas
- Gestational Diabetes Research and Management · Infant Nutrition and Health · Fatty Acid Research and Health
- Keywords
- Medicine, Gestational diabetes, Diabetes mellitus, Overweight, Incidence (geometry), Placebo, Fish oil, Randomized controlled trial, Internal medicine, Clinical trial, Probiotic, Obesity, Gestation, Fish <Actinopterygii>, Obstetrics, Pregnancy, Endocrinology, Pathology
- MeSH
- humans, pregnancy complications, diabetes, gestational, insulin resistance, obesity, fish oils, placebos, glucose tolerance test, pregnancy outcome, treatment outcome, incidence, risk factors, double-blind method, pregnancy, dietary supplements, probiotics, adult, female, overweight
8 authors
From FI
- Outi Pellonperä · correspondingUniversity of Turku; Turku University Hospital
- Kati MokkalaUniversity of Turku
- Noora HouttuUniversity of Turku
- Tero J. VahlbergUniversity of Turku
- Ella KoivuniemiUniversity of Turku
- Kristiina TerttiUniversity of Turku; Turku University Hospital
Abstract
Objective
To assess whether the risk of gestational diabetes mellitus (GDM) may be lowered and glucose metabolism improved by daily administration of fish oil and/or probiotic supplements in overweight and obese pregnant women.
Research design and methods
We randomized in a double-blind manner 439 women (mean 13.9 ± 2.1 gestational weeks [gw]) into four intervention groups: fish oil + placebo, probiotics + placebo, fish oil + probiotics, and placebo + placebo. Fish oil (1.9 g docosahexaenoic acid and 0.22 g eicosapentaenoic acid) and probiotic supplements (Lactobacillus rhamnosus HN001 and Bifidobacterium animalis ssp. lactis 420, 1010 colony-forming units each) were provided for daily consumption from randomization beyond delivery. Primary outcomes were the incidence of GDM diagnosed with oral glucose tolerance test targeted at 24-28 gw and the change in fasting glucose between randomization and late pregnancy (mean 35.2 ± 0.9 gw). Insulin concentration, insulin resistance HOMA2-IR index, and pregnancy outcomes were determined, as were adverse effects related to the intervention. Analyses were by intent to treat.
Results
No differences were found among the intervention groups in the maternal and neonatal pregnancy outcomes or side effects related to the intervention (P > 0.05). The proportion of women with GDM (94 of 377; fish oil + placebo, 23 of 96, 24.0%; probiotics + placebo, 25 of 99, 25.3%; fish oil + probiotics, 26 of 91, 28.6%; and placebo + placebo, 20 of 91, 22.0%) and the change in glucose, insulin, or HOMA2-IR (n = 364) did not differ among the intervention groups (P > 0.11 for all comparisons).
Conclusions
An intervention with fish oil and/or probiotics during pregnancy seemed to be both safe and well tolerated but conferred no benefits in lowering the risk of GDM or improving glucose metabolism in overweight and obese women.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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