Impact of Fish Oil or Probiotic Intake on Maternal Obesity and Molecular Biomarkers in the Placenta
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
研究概览
简要总结
Obesity is one of the most concerning health issues in the modern world, especially due to its association with greater risk of developing a wide range of chronic diseases. Pre-gestational obesity may increase the chances of maternal and fetal morbimortality, such as gestational diabetes mellitus, preeclampsia, macrosomia and, even, fetal death. It may also lead to long term disorders, enhancing the risk of excessive adiposity and metabolic syndrome in later life and, thus, contributing to the maintenance of the obesity cycle and its health effects through the subsequent generations. Alterations in placental function are thought to be deeply involved in this scenario, however further research on its molecular and biological mechanisms is needed. During pregnancy, there is a physiological enhancement of the inflammatory state, marked by higher circulating cytokines and macrophage placental infiltration, which favors fetal nutrient supply and adequate growth; however, this response is exacerbated in women with pre-pregnancy obesity, leading to adverse outcomes. In this context, interventions aiming to reduce excessive inflammation may prevent or minimize the negative impact of pre-pregnancy obesity on both maternal and offspring's health. There is strong evidence suggesting an important role of n-3 LC-PUFA (EPA and DHA) on the attenuation and resolution of inflammatory states, besides influencing maternal lipid profile, fetal and infant adipogenesis and neurodevelopment. Additionally, the consumption of probiotic supplements during gestation seams to promote adequate maternal weight gain and improve the profile of inflammatory molecules secreted in the milk. Therefore, the nutritional interventions with fish oil, as a source of EPA and DHA, or probiotics, in women with pre-pregnancy obesity, may change the intrauterine environment and reduce the risk of both short and long term metabolic disorders. This study aims to investigate the metabolic and molecular changes promoted by gestational obesity and evaluate the effectiveness of different dietary interventions (fish oil or probiotic) on preventing or minimizing such alterations. We expect to contribute to the understanding of the physiological and molecular mechanisms underlying maternal obesity and its association with adverse pregnancy outcomes, associated with increased risk of chronic diseases in adulthood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 19 and 40 years
- •gestational age of 13 weeks;
- •BMI prepregnancy greater than 29.9 and less than 40 kg / m² [ degrees obesity 1 and 2, according to the World Health Organization (WHO, 2002) ] or prepregnancy BMI between 18.5 and 24 9 kg / m² [ eutrophic ( WHO, 2002 ) ]
- •be free of chronic diseases (hypertension , cardiovascular disease, type 2 diabetes , thyroid diseases , cirrhosis , chronic hepatitis and chronic renal failure
- •be free of infectious and parasitic diseases
- •present gestation single fetus
- •not being a smoker
- •do not consume alcoholic beverages
- •do not consume supplement containing AG
排除标准
- •receive confirmation of diagnosis of chronic noncommunicable diseases (except obesity) and / or infectious
- •pregnant women who did not complete all the steps provided for in the study
研究组 & 干预措施
Eutrophy Control
Gelatin capsules a day, from 28ª week to 36ª week gestation.
干预措施: Placebo (Dietary Supplement)
Eutrophy+ Probiotic
Capsules gastro resistant containing 2.5 billions colony forming unit (UFC) Lactobacillus rhamnosus GG + 2.5 billions colony forming unit (UFC) Bifidobacterium bifidum a day, from 28ª week to 36ª week gestation
干预措施: Probiotic (Dietary Supplement)
Obesity + Probiotic
2.5 billions colony forming unit (UFC) Lactobacillus rhamnosus GG + 2.5 billions colony forming unit (UFC) Bifidobacterium bifidum a day, from 28ª week to 36ª week gestation
干预措施: Probiotic (Dietary Supplement)
Obesity + Fish oil
DHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
时间窗: 28 weeks
Association between fish oil intake in obese mothers and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
时间窗: 28 weeks
Investigation of the effects of fish oil supplementation on the metabolome of maternal serum, umbilical cord serum and placenta in obese pregnant women.
时间窗: 28 weeks
The metabolome of maternal serum, umbilical cord serum and placenta of obese and healthy pregnant women was analyzed by nuclear magnetic resonance.
Association between probiotic supplementation and bacterial colonization in the maternal intestinal and vaginal microbiota
时间窗: 36 weeks
Evaluation of the maternal intestinal and vaginal microbiota through the quantification of bacteria
次要结局
- Association between maternal obesity and placental fatty acid transporter expression(28 weeks)
- Association between fish oil intake in obese mothers and placental fatty acid transporter(28 weeks)
- Association between maternal inflammatory status and pregnancy outcomes(28 weeks)
研究者
Fátima Lúcia de Carvalho Sardinha
Professor
Universidade Federal do Rio de Janeiro
