Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/11/2017
Date assigned
12/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Maternal obesity during pregnancy has been linked with higher fetal fat mass, which could be related to higher incorporation of circulating fatty acids into fetal adipose (fat) tissue, promoting fetal programming of obesity. However, the role of the placenta in the selective transfer of specific fatty acids is unknown. Previous studies on women with gestational diabetes have found disturbed fatty acid transfer to the fetus which might also affect the neurodevelopment of the newborn. Similar results could also occur in maternal obesity but it is unknown. The aim of this study is to assess the transfer of the different fatty acids in obese mothers compared to healthy pregnant women.

Who can participate?
Pregnant women aged 18-40 who are planning to undergo an elective caesarean section at term

What does the study involve?
Ten obese and ten normal weight pregnant women take labelled fatty acids orally 12 hours before they undergo a caesarean section. Maternal plasma (blood) samples are taken at different timepoints until delivery, when cord blood and placenta samples are collected. Fatty acid levels are then measured.

What are the possible benefits and risks of participating?
This study attempts to provide better knowledge on the transfer of fatty acids with the aim of improving dietary recommendations for obese pregnant women. Participants might benefit from the results of this study in future pregnancies, as well as the whole population of women of reproductive age. There are no risks for the participating pregnant women or their babies. Labelled fatty acids have been used in previous studies without any side effects. Nevertheless, a medical insurance is signed in order to cover any unlikely negative event.

Where is the study run from?
1. "Virgen de la Arrixaca" Clinical Hospital (Spain)
2. University of Murcia (Spain)
3. Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich (Germany)

When is the study starting and how long is it expected to run for?
February 2012 to October 2017

Who is funding the study?
This work is financially supported in part by the Commission of the European Communities, Projects Early Nutrition, DYNAHEALTH and LIFECYCLE, the European Research Council Advanced Grant META-GROWTH, and the Excellence Network for Maternal and Child Health and Development

Who is the main contact?
Prof. Elvira Larque

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elvira Larqué

ORCID ID

Contact details

Department of Physiology
School of Biology
Campus de Espinardo
Murcia
30100
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KBBE.2011.2.2-03

Study information

Scientific title

In vivo materno-fetal fatty acid transfer in normal and obese pregnancy

Acronym

Study hypothesis

Maternal obesity at conception is considered a major predictor of offspring obesity. The pathophysiological mechanisms involved in the early programming of obesity are not fully understood. This study aimed to investigate the role of materno-fetal transfer of fatty acids in obese pregnant women using stable isotopes.

Ethics approval

Ethics Committee of the Virgen de la Arrixaca Clinical Hospital, 29/04/2013, ref: 04/13

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Obesity

Intervention

Ten obese and ten normal weight pregnant women (control) received orally 13C-labelled fatty acids 12h before elective caesarean section: oleic acid, linoleic acid and docosahexaenoic acid. Maternal plasma samples were taken before tracer administration and at different timepoints until delivery, when cord blood and placenta samples were collected. 13C-enrichment and 13C-fatty acid concentrations were determined by gas chromatography combustion isotope ratio mass spectrometry.

Intervention type

Other

Phase

Drug names

Primary outcome measure

13C-enrichment and 13C-fatty acid concentrations in samples of plasma, placenta and cord blood, measured by gas chromatography combustion isotope ratio mass spectrometry at baseline and during the 12h before the cesarean section

Secondary outcome measures

13C-enrichment and 13C-fatty acid concentrations in maternal plasma lipoproteins, measured by gas chromatography combustion isotope ratio mass spectrometry at baseline and during the 12h before the cesarean section

Overall trial start date

01/02/2012

Overall trial end date

30/10/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Singleton pregnancy
2. Age 18-40 years
3. Plan to undergo elective caesarean section at term
4. Omnivorous diet
5. No DHA supplements (last trimester)
6. Non-smoking
7. Normal fetal Doppler scan within the normal reference range (24) on the day before caesarean section

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

Any health problem of the mother or fetus, diabetes, gestational diabetes, preeclampsia

Recruitment start date

13/05/2013

Recruitment end date

15/04/2015

Locations

Countries of recruitment

Germany, Spain

Trial participating centre

"Virgen de la Arrixaca" Clinical Hospital
Murcia
30120
Spain

Trial participating centre

Department of Physiology, University of Murcia
Murcia
30100
Spain

Trial participating centre

Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich
Munich
80337
Germany

Sponsor information

Organisation

Commission of the European Communities

Sponsor details

EU
Murcia
30100
Spain

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

This work is financially supported in part by the Commission of the European Communities, Projects Early Nutrition (FP7-289346), DYNAHEALTH (H2020-633595) and LIFECYCLE (H2020-SC1-2016-RTD), the European Research Council Advanced Grant META-GROWTH (ERC-2012-AdG 322605), and the Excellence Network for Maternal and Child Health and Development (RED SAMID III, RD 16/0022/0009)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the results in peer-reviewed journals in 2018-2019. The protocol and statistical analyses will be published together with the results of the project.

IPD sharing statement
According to the Spanish law of Personal Data Protection, the individual data collected are only available for partners on the repository intranet from the European project Early Nutrition (FP7-289346).

Intention to publish date

30/10/2018

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes