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 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Suomen Lääketieteen Säätiö
- Organización sin fines de lucro
- Fondazione Diabete Ricerca
- Gobierno
- Academy of Finland
- Organización sin fines de lucro
- Juho Vainion Säätiö
- Gobierno
- Business Finland
- Organización sin fines de lucro
- The Finnish Medical Foundation
- Gobierno
- state research funding for university-level health research of the Turku University Hospital Expert Responsibility Area
- Organización sin fines de lucro
- Diabetes Research Foundation
- Organización sin fines de lucro
- Juho Vainio Foundation
- Subvenciones
- Academy of Finland (#258606); Business Finland (#3486/31/2015)
Según 9 financiadores declarados.
Publicación
- Publicado
- 2019-04-09 · Diabetes Care · vol. 42 · número 6 · págs. 1009–1017
- Editorial
- American Diabetes Association
- Citado
- 145 citas · más que el 99% de estudios similares · 14.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 46 trabajos
- Acceso
- De pago
- Áreas de investigación
- Gestational Diabetes Research and Management · Infant Nutrition and Health · Fatty Acid Research and Health
- Palabras clave
- 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 autores
- Outi Pellonperä🇫🇮 · autor de correspondenciaUniversity of Turku; Turku University Hospital
- Kati Mokkala🇫🇮University of Turku
- Noora Houttu🇫🇮University of Turku
- Tero J. Vahlberg🇫🇮University of Turku
- Ella Koivuniemi🇫🇮University of Turku
- Kristiina Tertti🇫🇮University of Turku; Turku University Hospital
- Tapani Rönnemaa🇫🇮University of Turku; Turku University Hospital
- Kirsi Laitinen🇫🇮University of Turku
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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