Gestational Obesity and Interventions With Probiotics or Fish Oil Trial (GOPROFIT)

July 10, 2017 updated by: Fátima Lúcia de Carvalho Sardinha, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22240-000
        • Recruiting
        • Maternidade Escola da Universidade Federal do Rio de Janeiro
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Danielle N Melo, Esp.
        • Sub-Investigator:
          • Camila M G Cortat, Ms

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Eutrophy Control
Gelatin capsules a day, from 28ª week to 36ª week gestation.
Dietary supplement: Placebo
EXPERIMENTAL: 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
Dietary supplement: Probiotic
EXPERIMENTAL: Obesity + Fish oil
DHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation
Dietary supplement: Fish Oil
EXPERIMENTAL: 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
Dietary supplement: Probiotic

What is the study measuring?

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
Time Frame: 28 weeks
28 weeks
Association between fish oil intake in obese mothers and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
Time Frame: 28 weeks
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.
Time Frame: 28 weeks
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
Time Frame: 36 weeks
Evaluation of the maternal intestinal and vaginal microbiota through the quantification of bacteria
36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between maternal obesity and placental fatty acid transporter expression
Time Frame: 28 weeks
28 weeks
Association between fish oil intake in obese mothers and placental fatty acid transporter
Time Frame: 28 weeks
28 weeks
Association between maternal inflammatory status and pregnancy outcomes
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Maternidade Escola da UFRJ

Investigators

  • Study Director: Fátima Lúcia C Sardinha, PhD, Instituto de Nutrição Josué de Castro/ UFRJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (ACTUAL)

July 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBqN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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