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Pregnancy, Physical ActivityNCT05496712

Effect of Physical Activity in Pregnancy on Maternal and Fetal Human Milk Oligosaccharides: a Pilot Study

An observational study of Pregnancy, Physical Activity, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective observational study investigates the interaction of maternal physical activity (PA) and body composition during pregnancy with prenatal Human Milk Oligosaccharide (HMO) concentrations, and assesses associations of HMOs with fetal/neonatal outcomes. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Physical Activity
How many people
230 participants
Where
1 siteAustria
Study dates
1 Jul 2014to Jun 2023
Phase
Observational
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Eligible are women with an on-going healthy pregnancy. Physical activity will be objectively measured by accelerometer. Women will be recruited as soon as possible in their pregnancy, but not after the 14th week of gestation. They will be recruited through the outpatient clinic at the Department of Obstetrics, Medical University Graz.

Who may be able to join

  • ongoing pregnancy no later than 14 weeks of gestation
  • giving informed consent

Who cannot join

  • not wanting to give birth at the university hospital
  • gestational age > 14th week of gestation
  • multiple pregnancy
  • 3 or more consecutive miscarriages
  • increased risk ≥ 1:100 after combined test (minimum parameters: maternal age, Fetal CRL, nuchal translucency, nasal bone and maternal biochemistry - free-ß-hCG and PAPP-A) and no NIPT (Non-Invasive Prenatal Testing) or no invasive testing for chromosomal anomalies
  • fetal anomalies which are associated with possible growth or genetic anomalies
Show all 10Show fewer
  • smoking
  • pre-pregnancy diabetes type 1 or 2 (T1D, T2D)
  • maternal metabolic risk factors (autoimmune conditions, increased risk for thromboembolic events needing anticoagulative therapy)
  • pre-pregnancy hypertension

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz

    Graz, Styria, 8043

Other trials in Austria

About this study

This prospective observational study investigates the interaction of maternal physical activity (PA) and body composition during pregnancy with prenatal Human Milk Oligosaccharide (HMO) concentrations, and assesses associations of HMOs with fetal/neonatal outcomes.

Read the detailed description

Maternal obesity is a known risk factor for adverse short- and long-term health outcomes for the offspring. In non-pregnant individuals, obesity can alter glucose and fat metabolism, and induce a low-grade inflammation. Pregnancy is a natural state of low-grade inflammation in the mother and the feto-placental unit, and the severity of this inflammation increases with higher pre-gravid BMI. Consequently, in pregnant women, obesity could account for an altered intrauterine environment that might affect fetal development and programming.

Regular physical activity (PA) is associated with a reduced inflammatory state. PA has been determined as a major factor contributing to fetal growth and body composition, besides maternal nutrition, gestational diabetes and obesity.

Human milk oligosaccharides (HMOs), highly bioactive factors in breast milk, but also present in the systemic circulation of pregnant women, may be one of the factors altered by metabolic changes seen in obesity, which might have an impact on the health of the offspring. HMOs have been implicated in multiple beneficial effects for the breast-fed infant, and also have anti-inflammatory and immuno-modulating effects.

HMOs are found in the urine of pregnant and lactating women, indicating that HMO circulate in the maternal blood system during pregnancy and throughout lactation. HMOs can also be detected in umbilical cord blood, suggesting either transplacental transfer or fetal production and release, raising the question whether maternal and fetal HMOs have a health impact on mother and fetus and, consequently, could be monitored as potential biomarkers for adverse pregnancy outcomes.

More than 150 HMO structures are known, and HMO composition and concentration in breast milk vary significantly between mothers and also within one mother due to different stages of lactation. Genetic factors and potentially also environmental factors contribute to the composition of HMOs in an individual. Different prenatal HMO profiles could potentially affect maternal and fetal health. Whether HMO composition and concentrations are different in women with overweight or obesity is not known. Exposure to a changed intrauterine environment could potentially pose a risk factor for certain pregnancy outcomes or cause aberrant fetal programming. At the same time, lifestyle factors that can counteract some obesity-induced metabolic changes such as physical activity and diet could potentially also have an effect on HMO concentration/composition.

The overall objective of the study is to investigate the interaction of maternal physical activity on HMOs in maternal and fetal circulation.

Specific Aims are:

  • To longitudinally determine maternal HMO concentration and composition during gestation to describe variability and temporal changes.
  • To assess fetal HMO concentration and composition to gain insight about origin: comparison arterial vs. venous cord blood; maternal vs. fetal HMOs.
  • To investigate associations of maternal and fetal HMOs with maternal body mass index/physical activity, and fetal growth/body composition.
Keywords
Human Milk Oligosaccharides
Medical subject headings
Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Human milk oligosaccharides (HMO) composition and concentration in maternal blood

    HMOs will be analysed in maternal blood by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: 6 months

  2. Human milk oligosaccharides (HMO) composition and concentration in fetal blood

    HMOs will be analysed in fetal (umbilical cord) blood by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: 6 months

  3. Human milk oligosaccharides (HMO) composition and concentration in maternal urine

    HMOs will be analysed in maternal urine by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: 6 months

  4. Human milk oligosaccharides (HMO) composition and concentration in colostrum

    HMOs will be analysed in colostrum by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: 6 months

Secondary outcomes (31)

  1. Fetal growth

    fetal growth (longitudinal ultrasound measurements)

    Measured: 6 months

  2. Birth weight

    infant weight at birth (scale)

    Measured: 6 months

  3. Fetal body fat mass

    Fetal body fat mass (measured by air displacement plethysmography, PEAPOD)

    Measured: 6 months

  4. Fetal fat free mass

    Fat free mass (measured by air displacement plethysmography, PEAPOD)

    Measured: 6 months

  5. Subcutaneous adipose tissue thickness

    Subcutaneous adipose tissue thickness (measured by lipometer at 15 defined body sites)

    Measured: 6 months

  6. Cord blood metabolic parameters - Glucose

    Glucose

    Measured: 6 months

  7. Cord blood metabolic parameters- Insulin

    Insulin

    Measured: 6 months

  8. Cord blood metabolic parameters - C-Peptide

    C-peptide

    Measured: 6 months

  9. Cord blood metabolic parameters - erythropoietin

    Erythropoietin (measure for fetal hypoxia)

    Measured: 6 months

  10. Cord blood metabolic parameters - lipid profile

    lipid profile (triglycerides, phospholipids, free fatty acids, HDL proteome)

    Measured: 6 months

  11. Cord blood metabolic parameters - Cytokines

    Cytokines

    Measured: 6 months

  12. Maternal body composition - BMI

    Body mass index (BMI)

    Measured: 6 months

  13. Maternal body composition - weight gain

    gestational weight gain

    Measured: 6 months

  14. Maternal body composition - subcutaneous adipose tissue thickness

    subcutaneous adipose tissue thickness (measured by lipometer at 15 defined body sites)

    Measured: 6 months

  15. Maternal parameters - Glucose

    glucose

    Measured: 6 months

  16. Maternal parameters - Insulin

    insulin

    Measured: 6 months

  17. Maternal parameters - C-Peptide

    C-peptide

    Measured: 6 months

  18. Maternal parameters - Leptin

    Leptin

    Measured: 6 months

  19. Maternal parameters - Adiponectin

    Adiponectin

    Measured: 6 months

  20. Maternal parameters - Liquid profile

    Lipid profile (triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol)

    Measured: 6 months

  21. Maternal parameters - Cytokines

    Cytokines

    Measured: 6 months

  22. Placental outcomes - Utero-placental blood flow

    Utero-placental blood flow (ultrasound/Doppler)

    Measured: 6 months

  23. Placental outcomes - fetal-placental blood flow

    fetal-placental blood flow (ultrasound/Doppler)

    Measured: 6 months

  24. Placental volume

    placental volume (ultrasound)

    Measured: 6 months

  25. Placental outcomes - Cytokine mRNA

    Cytokine mRNA

    Measured: 6 months

  26. Placental outcomes - Macrophage density

    Macrophage density (number/tissue protein)

    Measured: 6 months

  27. Placental outcomes - TREG density

    Treg density (number/tissue protein)

    Measured: 6 months

  28. Placental outcomes - placental volume

    placental volume

    Measured: 6 months

  29. Placental outcomes- transcriptomic profile

    Transcriptomic profile, RNAseq on a NovaSeq 6000 (Illumina)

    Measured: 6 months

  30. Placental outcomes - epigenomic profile

    Epigenomic profile measured by DNA methylation

    Measured: 6 months

  31. Vaginal Microbiome

    From the extracted DNA, 16S rRNA genes will be amplified using specific primers for bacterial and archaeal communities. The amplicons obtained will be prepared for Illumina MiSeq Sequencing.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start1 Jul 2014
  3. Primary completionJun 2023
  4. Study completionJun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496712
Sponsor's protocol ID
26-380 ex 13/14
Status last verified
Aug 2024
First submitted
9 Aug 2022
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garcia MG, Hamann E, Huhn EA, Forbes K, Roser P, Weiser-Fuchs MT, Dieberger AM, Csapo B, Obermayer-Pietsch B, Poppel MNMV, Fluhr H, Jantscher-Krenn E, Blois SM. Maternal Galectins and Glucose Regulation in Pregnancy: Chronic vs. Acute Metabolic Adaptations. Diabetes Metab J. 2026 Mar;50(2):343-356. doi: 10.4093/dmj.2025.0401. Epub 2025 Dec 29.

    PubMed 41299831

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, Physical Activity, run by Medical University of Graz at 1 site in Austria.

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 2 inclusion and 10 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: finished, as of the sponsor's last update on 28 Aug 2024. 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 Austria. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Human milk oligosaccharides (HMO) composition and concentration in maternal blood (time frame: 6 months). 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 NCT05496712, which also lists 1 linked publication.

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 28 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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