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

Diabetes Care
Q1
Apr 2019
Citations:119
Influential Citations:8
Interventional (Human) Studies
85
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Methods
Double-blind, placebo-controlled randomized trial in overweight/obese pregnant women (prepregnancy BMI ≥25 kg/m2), mean age ~30 years, recruited at mean gestational age 13.9 weeks; single center (Turku University Hospital, Finland); N=439 allocated to four groups; outcomes assessed by intention-to-treat; exclusions included diabetes before pregnancy, coagulation disorders, and anticoagulant use.
Intervention
Two fish oil capsules daily (total n-3 fatty acids 2.4 g; DHA 1.9 g; EPA 0.22 g) and one probiotic capsule daily containing Lactobacillus rhamnosus HN001 and Bifidobacterium animalis ssp. lactis 420, 1010 CFU each; duration from early pregnancy through delivery and up to 6 months postpartum; taken orally.
Results
No significant differences among groups in maternal or neonatal outcomes or adverse effects (P>0.05). GDM incidence by group: fish oil+placebo 23/96 (24.0%), probiotics+placebo 25/99 (25.3%), fish oil+probiotics 26/91 (28.6%), placebo+placebo 20/91 (22.0%) (P>0.11). Changes in fasting glucose, insulin, or HOMA2-IR from early to late pregnancy did not differ among groups (P>0.11). Conclusion: Fish oil and/or probiotic supplementation during pregnancy is safe but does not reduce GDM risk or improve glucose metabolism in overweight and obese pregnant women.
Limitations
Single-center study; population limited to overweight/obese pregnant women (BMI ≥25 kg/m2) which limits generalizability; powered to detect a 20% relative reduction in GDM; actual effects may be smaller; attrition with withdrawals before OGTT (8.9%) and before late pregnancy (13.5%) may affect precision; postpartum outcomes not addressed; duration and dosage may influence detectability of effects.

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 ME...