Actively Recruiting

Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT03634930

Josef Ressel Centre Perinatal Programming

Led by Moenie van der Kleyn · Updated on 2025-03-17

100

Participants Needed

1

Research Sites

488 weeks

Total Duration

On this page

Sponsors

M

Moenie van der Kleyn

Lead Sponsor

C

Christian Doppler Forschungsgesellschaft

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Breastfeeding in the first year of life appears to be protective against obesity development. Objective: of the "Josef Ressel Centre for Early Life Metabolic Programming of Dispositions of Obesity" is to identify maternal and infant predictors of metabolic risk of obesity. The main considerations of modifiable factors are early infant nutrition, 24-hours-drinking-volume, the velocity of infant weight gain, in relation to infant fat mass and fat free mass, to biomarker and to the nutritional status of the mother. A second focus is put on maternal feeding style, infant eating behaviour and the identification of satiety cues. Multi-Study design: a monocentric prospective longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their term, normal birthweight, singleton babies. Mothers and exclusively breastfed versus exclusively formula fed children (at 16 weeks) will be examined at 36 weeks of pregnancy, 4 - 8 - 12 and 16 weeks of life, follow-up at 1 and 2 years of life. Methods: four weighing protocols between 4th and 16th week of life, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph. Macronutrient and energy content of the breast milk will be analysed by MIRIS™. Well-defined biomarkers of oxidative stress and inflammation, lipid profile, adipokines, insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more. Also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and 2 years. A semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure.

CONDITIONS

Official Title

Josef Ressel Centre Perinatal Programming

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnancy or mother in puerperium
  • Delivery of baby at 37+0 to 41+6 gestational age
  • Legal age (18 years old), age limit 50 years
  • Written consent of test person after having been informed
  • BMI  18.5 kg/m8 to < 30 kg/m8
  • Negative result of oral glucose tolerance test during pregnancy
  • Birth weight of baby 2.5-4.5 kg
  • Non-smoker since knowledge of pregnancy
  • Very good knowledge of German language and Caucasian
  • Exclusive breastfeeding or exclusive formula feeding at 4th week of life
Not Eligible

You will not qualify if you...

  • Birth before 37+0 week of pregnancy or after 41+6 week of pregnancy
  • Multiple pregnancy
  • Children with serious congenital malformations of nervous system, mouth, throat, neck, circulation system, respiratory tract, gastrointestinal tract, urogenital tract, or chromosomal aberrations
  • Diseases or hospitalization or intensive medical care of child during neonatal period
  • Hereditary metabolic diseases of child including disorders of fat, amino acid, or carbohydrate metabolism
  • Drug (tobacco) abuse
  • Mental illnesses treated with medication
  • Metabolic or autoimmune diseases of mother
  • Complications at birth such as blood loss over 1000 ml or eclampsia
  • Pre-conceptional diabetes (type 1 or 2)
  • Celiac disease and/or wheat protein allergy of mother
  • Breast surgery and/or hypomastia
  • Mixed feeding at 4th week of life

AI-Screening

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Trial Site Locations

Total: 1 location

1

FH Joanneum, university of applied sciences

Graz, Styria, Austria, 8020

Actively Recruiting

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Research Team

M

Moenie D van der Kleyn, MPH

CONTACT

E

Erwin Zinser, Prof Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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