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Gestational Obesity and Interventions With Probiotics or Fish Oil Trial

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03215784
Acronym
GOPROFIT
Enrollment
80
Registered
2017-07-12
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Obesity, Pregnancy

Keywords

obesity, placenta, inflammation, fish oil, probiotics

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.

Interventions

DIETARY_SUPPLEMENTFish Oil
DIETARY_SUPPLEMENTProbiotic
DIETARY_SUPPLEMENTPlacebo

Sponsors

Maternidade Escola da UFRJ
CollaboratorUNKNOWN
Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways28 weeks
Association between fish oil intake in obese mothers and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways28 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 weeksThe 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 microbiota36 weeksEvaluation of the maternal intestinal and vaginal microbiota through the quantification of bacteria

Secondary

MeasureTime frame
Association between fish oil intake in obese mothers and placental fatty acid transporter28 weeks
Association between maternal inflammatory status and pregnancy outcomes28 weeks
Association between maternal obesity and placental fatty acid transporter expression28 weeks

Countries

Brazil

Contacts

Primary ContactFátima Lúcia C Sardinha, PhD
sardinhaflc@nutricao.ufrj.br(55) 21 996355046
Backup ContactTatiana P El-Bacha, PhD
tatiana@nutricao.ufrj.br(55) 21 997667997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026