Gestational Obesity and Interventions With Probiotics or Fish Oil Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Pregnancy, Inflammation

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Eutrophy Control<br>Gelatin capsules a day, from 28ª week to 36ª week gestation. | Dietary Supplement: Placebo<br> <br> |
| Experimental: Eutrophy+ Probiotic<br>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 | Dietary Supplement: Probiotic<br> <br> |
| Experimental: Obesity + Fish oil<br>DHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation | Dietary Supplement: Fish Oil<br> <br> |
| Experimental: Obesity + Probiotic<br>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 | Dietary Supplement: Probiotic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways |  | 28 weeks | 
| Association between fish oil intake in obese mothers and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways |  | 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. | The metabolome of maternal serum, umbilical cord serum and placenta of obese and healthy pregnant women was analyzed by nuclear magnetic resonance. | 28 weeks | 
| Association between probiotic supplementation and bacterial colonization in the maternal intestinal and vaginal microbiota | Evaluation of the maternal intestinal and vaginal microbiota through the quantification of bacteria | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, placenta, inflammation, fish oil, probiotics