The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.

NCT01778205 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 831

Last updated 2021-09-23

No results posted yet for this study

Summary

The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at \<12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at \<12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.

Conditions

  • Intrauterine Development

Interventions

OTHER

Observational

Sponsors & Collaborators

  • Italfarmaco

    collaborator INDUSTRY
  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • State Research Agency, Spain

    collaborator OTHER_GOV
  • JPI ERA-HDHL

    collaborator UNKNOWN
  • University Rovira i Virgili

    collaborator OTHER
  • European Regional Development Fund

    collaborator OTHER
  • Institut Investigacio Sanitaria Pere Virgili

    lead OTHER

Principal Investigators

  • Michelle M Murphy, PhD · University Rovira i Virgili

  • Pere Cavallé-Busquets, MD, PHD · Hospital Universitari Sant Joan de Reus

  • Joan D Fernandez-Ballart, PhD · University Rovira i Virgili

  • Mónica Ballesteros, MD, PHD · Hospital de Tarragona Joan XXIII

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2020-09-14
Completion
2020-09-14

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778205 on ClinicalTrials.gov