Clinical trial
Josef Ressel Centre Perinatal Programming
Recruiting now · Not applicable · 1 countries · Registry ID NCT03634930
What this study 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.
Basic eligibility
Full registry criteria
Treatments and study arms
observation
Observation of growth, infant bodycomposition, 24h-drinkingvolume
Primary outcomes
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).
weight in kilograms, height in meters will be combined to report BMI in (kg/m\^2)
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).
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.
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.
Study locations
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