跳至主要内容
临床试验/NCT03215784
NCT03215784Unknown不适用

Impact of Fish Oil or Probiotic Intake on Maternal Obesity and Molecular Biomarkers in the Placenta

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年3月最近更新:
适应症
干预措施

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

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

Placebo Comparator

Gelatin capsules a day, from 28ª week to 36ª week gestation.

干预措施: Placebo (Dietary Supplement)

Eutrophy+ Probiotic

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fátima Lúcia de Carvalho Sardinha

Professor

Universidade Federal do Rio de Janeiro

研究点 (2)

Loading locations...

相似试验

已完成
不适用
Allergy Prevention Study Using Fish oil in PregnancyAllergy
ACTRN12611000041954niversity of Western Australia80
已完成
不适用
Maternal Fish Oil Supplementation Study in high risk pregnanciesMaternal diabetes mellitus, pre-eclampsia, low birthweightPregnancy and ChildbirthDiabetes mellitus arising in pregnancy
ISRCTN24068733Mother and Child Foundation (UK)300
已完成
不适用
The effect of fish-oil supplementation on pregnancy outcomes in mother and infantCondition 1: Pregnancy, childbirth and the puerperium. Condition 2: Pregnancy, childbirth and the puerperium. Condition 3: Pregnancy, childbirth and the puerperium. Condition 4: Pregnancy, childbirth and the puerperium. Condition 5: Pregnancy, childbirth and the puerperium. Condition 6: Pregnancy, childbirth and the puerperium. Condition 7: Certain conditions originating in the perinatal period. Condition 8: Certain conditions originating in the perinatal period.Gestational [pregnancy-induced] hypertension with significant proteinuriaDiabetes mellitus in pregnancy, unspecifiedPreterm labour and deliverySingle delivery by caesarean sectionMental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperiumPregnancy-related condition, unspecifiedFetus and newborn affected by maternal nutritional disordersDisorders related to short gestation and low birth weight, not elsewhere classified
IRCT2013100914957N1ational Public-Health Management Center (NPMC)150
已完成
不适用
Marin Protein Hydrolysate and Metabolic SyndromeMetabolic Syndrome
NCT03807752Helse Møre og Romsdal HF33
已完成
不适用
Fish Oil Supplementation in LactationDevelopment and Health
NCT00266305University of Copenhagen150