Gestational Obesity and Interventions With Probiotics or Fish Oil Trial

Not Applicable

• Conditions: Inflammation; Obesity; Pregnancy
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Fish Oil; Dietary Supplement: Placebo

• Registration Number: NCT03215784
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2017-07
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obesity + Probiotic	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
Obesity + Fish oil	Fish Oil	DHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation
Eutrophy Control	Placebo	Gelatin capsules a day, from 28ª week to 36ª week gestation.
Eutrophy+ Probiotic	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

Primary Outcome Measures

Name	Time	Method
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.	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	36 weeks	Evaluation of the maternal intestinal and vaginal microbiota through the quantification of bacteria

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maternidade Escola da Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil