Josef Ressel Centre Perinatal Programming
JRP
Josef Ressel Centre for the Investigation of Early Life Metabolic Programming Regarding Dispositions of Obesity
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2017
CompletedFirst Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 17, 2025
March 1, 2025
8.9 years
July 24, 2018
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Changes in 24 hours drinking volume of milk intake
24 hours drinking volume (milliliter) of milk intake of exclusive breast fed versus exclusive formula fed children by 24h-testweighing on an MBC-15K2DM-Infantscale (Kern).
Changes from 4 to 8 to 12 and to 16 weeks of life
Changes in Body Mass Index (BMI) child
weight in kilograms, height in meters will be combined to report BMI in (kg/m\^2)
Changes from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
Changes in Fat Mass Index (FMI) child
weight of fat mass in kilograms, height in meters will be combined to report Fat Mass Index in kg/m\^2). Fat mass will be measured by air displacement plethysmography (ADP) system using whole body densitometry to determine body composition (fat and fat-free mass) using a PEA-POD™ and BOD-POD™ (COSMED Company USA).
Changes from 8 to 16 weeks of life and 2 years
Change in energy content of mature breast milk
Change in energy content of 3 ml mature breast milk will be determined by MIRIS HMA™ Human Milk Analyzer (Miris Holding AB, Sweden) in kcal/dL. Samples will be measured twice and mean values for all measured parameters will be calculated. Milk samples are gained by use of Harmony Breast Pump kit (Medela Inc., USA) and are immediately frozen at -80 °C. The samples are collected between 9 and 11 AM from one breast simultaneously to feeding at the other breast. Foremilk and hindmilk are mixed, sample size will be at least 20 ml.
from 8 to 16 weeks of life
Duration of exclusive milk feeding
The duration of the exclusivity of human milk- or formula feeding will be determined by means of a prospective feeding diary in which frequency, volume, content, administration form and the initiation of complementary food are recorded by the mother. Precise classification by trained study staff will be according to the WHO categories "sole" (exclusive), "predominant" and "partial" breastfeeding through determination of ratio of total breast milk intake per day to total milk intake of other fluids (like formula milk, water, tea etc.) or foods.
over the period from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
Secondary Outcomes (6)
Change of Eating Behaviour - baby
from 8 to 16 weeks of life
Change of Eating Behaviour - child
change from 1 year to 2 years of life
Change in Maternal Milk Feeding Style - Infant
from 8 to 16 weeks of life
Change in Maternal Feeding Style - Child
From 1 year to 2 years of life
Changes in dietary intake - maternal
from 36 week of pregnancy to 16 weeks, to 1 year to 2 years of life
- +1 more secondary outcomes
Other Outcomes (7)
Infant satiety cues of breast- and formula fed children
at 8 weeks of life
Changes in fecal microbial profile
Changes from 36 week of pregnancy to 8, 16 weeks of life, to 1 and 2 years
Changes in eicosanoids profiles
Change from 36 week of pregnancy to 8, 16 weeks of life, to 1 and 2 years
- +4 more other outcomes
Study Arms (2)
EBF exclusive breast fed children at 16 weeks
observation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv breastfed children at the age of 8 and 16 weeks, and at 1 and 2 Years
EFF exclusive formula fed children at 16 week
observation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv formula fed children at the age of 8 and 16 weeks, and at 1 and 2 Years
Interventions
Observation of growth, infant bodycomposition, 24h-drinkingvolume
Eligibility Criteria
term (37-41 gestational age), singleton healthy babies with normal birth weight (2.5-4.5 kg) from healthy, non-smoking, non-diabetic mothers with a normal pre-pregnancy BMI (18.5-30). Pregnant women, who plan to breastfeed will be selected from a primary care clinic (STGKK Graz) and young non-breastfeeding mothers will be selected at the maternity ward of the university hospital of Graz.
You may qualify if:
- 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/m² to \< 30 kg/m²
- Negative result of oGTT (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 MR 2 (4th week of life)
You may not qualify if:
- Birth before 37+0 week of pregnancy (WoP) or after the 41+6 WoP
- Multiple pregnancy
- Children with serious congenital malformations of
- Nervous system
- Mouth, throat, neck
- Circulation system
- Respiratory tract
- Gastrointestinal tract
- Urogenital tract
- Chromosomal aberrations
- Diseases or hospitalization or intensive medical care of child during neonatal period
- Hereditary metabolic diseases of child
- Hereditary disorders of fat metabolism (MCHAD: Medium Chain Acyl-CoA Dehydrogenase Deficiency, LCHAD: Long Chain Acyl-CoA Dehydrogenase Deficiency, VLCHAD: Very Long Chain Acyl-CoA Dehydrogenase Deficiency)
- Hereditary disorders of amino acid metabolism (PKU: Phenylketonuria)
- Hereditary disorders of carbohydrate metabolism (Glycogenosis, Galactosemia, Hereditary fructose intolerance, Diabetes mellitus Type 1)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moenie van der Kleynlead
- Christian Doppler Forschungsgesellschaftcollaborator
- Milupa GmbHcollaborator
Study Sites (1)
FH Joanneum, university of applied sciences
Graz, Styria, 8020, Austria
Related Links
Biospecimen
Human Milk, blood (mother and child), urine (child), saliva (mother and child) and stool sample (mother and child), hair sample (mother and child)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Moenie van der Kleyn, MPH
FH Joanneum Hebammen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Josef Ressel Centre
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 17, 2018
Study Start
February 16, 2017
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
March 17, 2025
Record last verified: 2025-03