ObesityGOPROFITNCT03215784
Gestational Obesity and Interventions With Probiotics or Fish Oil Trial
A study testing Fish Oil and Probiotic in people with Obesity and Pregnancy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pregnancy, Inflammation
- What is being tested?
- Fish Oil and Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- not being a smoker
- do not consume alcoholic beverages
- do not consume supplement containing AG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Maternidade Escola da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22240-000
Lívia B Almeida, Ms, (55) 21 991689325, livia.belcastro@gmail.com
Daniela B Mucci, Ms, (55) 21 991960867, danimucci@gmail.com
About this study
Official title: 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.
- Conditions
- Obesity, Pregnancy, Inflammation
- Being tested
- Fish Oil, Probiotic, Placebo
- Keywords
- obesity, placenta, inflammation, fish oil, probiotics
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
ProbioticDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Eutrophy Control | Placebo comparator | Gelatin capsules a day, from 28ª week to 36ª week gestation. Receives: Dietary Supplement: Placebo |
| 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 Receives: Dietary Supplement: Probiotic |
| Obesity + Fish oil | Experimental | DHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation Receives: Dietary Supplement: Fish Oil |
| 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 Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
Measured: 28 weeks
Association between fish oil intake in obese mothers and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
Measured: 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.
Measured: 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
Measured: 36 weeks
Secondary outcomes (3)
Association between maternal obesity and placental fatty acid transporter expression
Measured: 28 weeks
Association between fish oil intake in obese mothers and placental fatty acid transporter
Measured: 28 weeks
Association between maternal inflammatory status and pregnancy outcomes
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startMar 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Maternidade Escola da UFRJ
- Responsible party
- Principal investigator, Fátima Lúcia de Carvalho Sardinha, Universidade Federal do Rio de Janeiro
- Investigators
- Fátima Lúcia C Sardinha, PhD, Study director, Instituto de Nutrição Josué de Castro/ UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215784
- Sponsor's protocol ID
- LBqN
- Acronym
- GOPROFIT
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reynolds RM, Allan KM, Raja EA, Bhattacharya S, McNeill G, Hannaford PC, Sarwar N, Lee AJ, Bhattacharya S, Norman JE. Maternal obesity during pregnancy and premature mortality from cardiovascular event in adult offspring: follow-up of 1 323 275 person years. BMJ. 2013 Aug 13;347:f4539. doi: 10.1136/bmj.f4539.
PubMed 23943697Lawlor DA, Relton C, Sattar N, Nelson SM. Maternal adiposity--a determinant of perinatal and offspring outcomes? Nat Rev Endocrinol. 2012 Nov;8(11):679-88. doi: 10.1038/nrendo.2012.176. Epub 2012 Sep 25.
PubMed 23007319Medanic D, Pucarin-Cvetkovic J. [Obesity--a public health problem and challenge]. Acta Med Croatica. 2012 Dec;66(5):347-55. Croatian.
PubMed 23814963Sirimi N, Goulis DG. Obesity in pregnancy. Hormones (Athens). 2010 Oct-Dec;9(4):299-306. doi: 10.14310/horm.2002.1280.
PubMed 21112860Ingelfinger JR, Nuyt AM. Impact of fetal programming, birth weight, and infant feeding on later hypertension. J Clin Hypertens (Greenwich). 2012 Jun;14(6):365-71. doi: 10.1111/j.1751-7176.2012.00660.x. Epub 2012 May 21.
PubMed 22672090Al-Gubory KH, Fowler PA, Garrel C. The roles of cellular reactive oxygen species, oxidative stress and antioxidants in pregnancy outcomes. Int J Biochem Cell Biol. 2010 Oct;42(10):1634-50. doi: 10.1016/j.biocel.2010.06.001. Epub 2010 Jun 19.
PubMed 20601089Jordan RG. Prenatal omega-3 fatty acids: review and recommendations. J Midwifery Womens Health. 2010 Nov-Dec;55(6):520-8. doi: 10.1016/j.jmwh.2010.02.018.
PubMed 20974414Teixeira TF, Collado MC, Ferreira CL, Bressan J, Peluzio Mdo C. Potential mechanisms for the emerging link between obesity and increased intestinal permeability. Nutr Res. 2012 Sep;32(9):637-47. doi: 10.1016/j.nutres.2012.07.003. Epub 2012 Sep 7.
PubMed 23084636Larque E, Gil-Sanchez A, Prieto-Sanchez MT, Koletzko B. Omega 3 fatty acids, gestation and pregnancy outcomes. Br J Nutr. 2012 Jun;107 Suppl 2:S77-84. doi: 10.1017/S0007114512001481.
PubMed 22591905Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9.
PubMed 19646321Rautava S, Collado MC, Salminen S, Isolauri E. Probiotics modulate host-microbe interaction in the placenta and fetal gut: a randomized, double-blind, placebo-controlled trial. Neonatology. 2012;102(3):178-84. doi: 10.1159/000339182. Epub 2012 Jul 6.
PubMed 22776980El-Bacha T, Midlej V, Pereira da Silva AP, Silva da Costa L, Benchimol M, Galina A, Da Poian AT. Mitochondrial and bioenergetic dysfunction in human hepatic cells infected with dengue 2 virus. Biochim Biophys Acta. 2007 Oct;1772(10):1158-66. doi: 10.1016/j.bbadis.2007.08.003. Epub 2007 Sep 15.
PubMed 17964123Chen B, Longtine MS, Sadovsky Y, Nelson DM. Hypoxia downregulates p53 but induces apoptosis and enhances expression of BAD in cultures of human syncytiotrophoblasts. Am J Physiol Cell Physiol. 2010 Nov;299(5):C968-76. doi: 10.1152/ajpcell.00154.2010. Epub 2010 Sep 1.
PubMed 20810912Challier JC, Basu S, Bintein T, Minium J, Hotmire K, Catalano PM, Hauguel-de Mouzon S. Obesity in pregnancy stimulates macrophage accumulation and inflammation in the placenta. Placenta. 2008 Mar;29(3):274-81. doi: 10.1016/j.placenta.2007.12.010. Epub 2008 Feb 11.
PubMed 18262644Gaccioli F, Lager S, Powell TL, Jansson T. Placental transport in response to altered maternal nutrition. J Dev Orig Health Dis. 2013 Apr;4(2):101-15. doi: 10.1017/S2040174412000529.
PubMed 25054676
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fish Oil or Probiotic Intake on Maternal Obesity and Molecular Biomarkers in the Placenta
- ClinicalTrials.gov ID
- NCT03215784
- Acronym / sponsor ID
- GOPROFIT / LBqN
- Conditions
- Obesity, Pregnancy, Inflammation
- Keywords
- obesity, placenta, inflammation, fish oil, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Maternidade Escola da UFRJ
- Study start
- Mar 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eutrophy Control | Placebo comparator | Dietary Supplement: PlaceboGelatin capsules a day, from 28ª week to 36ª week gestation. |
| Eutrophy+ Probiotic | Experimental | Dietary Supplement: ProbioticCapsules 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 |
| Obesity + Fish oil | Experimental | Dietary Supplement: Fish OilDHA (100 mg) + EPA (137 mg) a day, from 13ª week gestation to 36ª week gestation |
| Obesity + Probiotic | Experimental | Dietary Supplement: Probiotic2.5 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 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish Oil | Dietary supplement | Obesity + Fish oil |
| Probiotic | Dietary supplement | Eutrophy+ Probiotic, Obesity + Probiotic |
| Placebo | Dietary supplement | Eutrophy Control |
Primary outcome
Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways
Time frame: 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
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.
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
3 secondary outcomes
Association between maternal obesity and placental fatty acid transporter expression
Time frame: 28 weeks
Association between fish oil intake in obese mothers and placental fatty acid transporter
Time frame: 28 weeks
Association between maternal inflammatory status and pregnancy outcomes
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Background: PubMed 23943697Reynolds RM, Allan KM, Raja EA, Bhattacharya S, McNeill G, Hannaford PC, Sarwar N, Lee AJ, Bhattacharya S, Norman JE. Maternal obesity during pregnancy and premature mortality from cardiovascular event in adult offspring: follow-up of 1 323 275 person years. BMJ. 2013 Aug 13;347:f4539. doi: 10.1136/bmj.f4539.
- Background: PubMed 23007319Lawlor DA, Relton C, Sattar N, Nelson SM. Maternal adiposity--a determinant of perinatal and offspring outcomes? Nat Rev Endocrinol. 2012 Nov;8(11):679-88. doi: 10.1038/nrendo.2012.176. Epub 2012 Sep 25.
- Background: PubMed 23814963Medanic D, Pucarin-Cvetkovic J. [Obesity--a public health problem and challenge]. Acta Med Croatica. 2012 Dec;66(5):347-55. Croatian.
- Background: PubMed 21112860Sirimi N, Goulis DG. Obesity in pregnancy. Hormones (Athens). 2010 Oct-Dec;9(4):299-306. doi: 10.14310/horm.2002.1280.
- Background: PubMed 22672090Ingelfinger JR, Nuyt AM. Impact of fetal programming, birth weight, and infant feeding on later hypertension. J Clin Hypertens (Greenwich). 2012 Jun;14(6):365-71. doi: 10.1111/j.1751-7176.2012.00660.x. Epub 2012 May 21.
- Background: PubMed 20601089Al-Gubory KH, Fowler PA, Garrel C. The roles of cellular reactive oxygen species, oxidative stress and antioxidants in pregnancy outcomes. Int J Biochem Cell Biol. 2010 Oct;42(10):1634-50. doi: 10.1016/j.biocel.2010.06.001. Epub 2010 Jun 19.
- Background: PubMed 20974414Jordan RG. Prenatal omega-3 fatty acids: review and recommendations. J Midwifery Womens Health. 2010 Nov-Dec;55(6):520-8. doi: 10.1016/j.jmwh.2010.02.018.
- Background: PubMed 23084636Teixeira TF, Collado MC, Ferreira CL, Bressan J, Peluzio Mdo C. Potential mechanisms for the emerging link between obesity and increased intestinal permeability. Nutr Res. 2012 Sep;32(9):637-47. doi: 10.1016/j.nutres.2012.07.003. Epub 2012 Sep 7.
- Background: PubMed 22591905Larque E, Gil-Sanchez A, Prieto-Sanchez MT, Koletzko B. Omega 3 fatty acids, gestation and pregnancy outcomes. Br J Nutr. 2012 Jun;107 Suppl 2:S77-84. doi: 10.1017/S0007114512001481.
- Background: PubMed 19646321Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9.
- Background: PubMed 22776980Rautava S, Collado MC, Salminen S, Isolauri E. Probiotics modulate host-microbe interaction in the placenta and fetal gut: a randomized, double-blind, placebo-controlled trial. Neonatology. 2012;102(3):178-84. doi: 10.1159/000339182. Epub 2012 Jul 6.
- Background: PubMed 17964123El-Bacha T, Midlej V, Pereira da Silva AP, Silva da Costa L, Benchimol M, Galina A, Da Poian AT. Mitochondrial and bioenergetic dysfunction in human hepatic cells infected with dengue 2 virus. Biochim Biophys Acta. 2007 Oct;1772(10):1158-66. doi: 10.1016/j.bbadis.2007.08.003. Epub 2007 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fátima Lúcia C Sardinha, PhD study director
Instituto de Nutrição Josué de Castro/ UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil and Probiotic in people with Obesity and Pregnancy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fátima Lúcia C Sardinha, PhD ((55) 21 996355046, sardinhaflc@nutricao.ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between maternal obesity and systemic Inflammation in the Mother and the Activation of Placental Inflammatory Pathways (time frame: 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215784, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.