NUTRIPROTECT-Children Nutrition as a Protective or Health-risk Factor
NCT04076592 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89
Last updated 2019-09-04
Summary
Despite the intensive worldwide research dedicated to the nutrition and faecal microbiota, the studies that follow the link between the early nutrition, initial intestinal microbiota, and development of children over a longer time period are limited. From 2010 to 2013, the investigators conducted a study "My-Milk" in Slovenia. From 185 participating pregnant women involved in the detailed part of the protocol (comprising of 4-days weighed dietary record, visits at clinic and biological sample collection), 152 participants completed the study at the child's first year of age. Five of the participants bore twins whose data was excluded from the research because infant's identity was not consistently followed throughout the research. In addition to studying the microbiota and fatty acid composition of breast milk and the initial development of intestinal microbiota of breastfed babies, the investigators also monitored the diet of expecting and nursing participants, concentration of vitamin D in serum and bone mineral density in participating mothers and children. The investigators performed anthropometric measurements of children during the first year of age. All singleton children who have completed My-Milk study (N= 147) will be invited in the follow-up study "My-Milk-2". The first step of the proposed study will be the evaluation of nutritional status of children aged 6 to 7 years in 2017/2018, including the assessment of the body composition (bone density, percentage of fat and muscle tissue), health indicators (blood pressure, blood cholesterol, frequency and severity of infections) and fecal microbiota. The obtained data of My-Milk and My-Milk-2 studies will enable the prospective cohort study to be carried out on the effects of early nutrition and various factors of mother and child during the first year of age on the health and developmental status of children aged 6- 7 years. The project results will significantly improve the progress in research areas of public health and nutrition. The interactions along the axis nutrition in early childhood, gut microbiota composition/ diversity and potential health problems in later life are still not fully explored. The investigators expect the results of the proposed study will contribute to the scientific development in this field in global prospective. The acquired information will also be an excellent basis for development of new dietary guidelines for children.
Conditions
- Breastfeeding
- Dietary Intake
- Health
- Body Composition
- Intestinal Microbiota
Sponsors & Collaborators
-
University Medical Centre Ljubljana
collaborator OTHER -
University of Ljubljana
lead OTHER
Principal Investigators
-
Irena Rogelj, Prof., PhD · University of Ljubljana
-
Rok Orel, MD, Prof., PhD · University Medical Centre Ljubljana, Division of Pediatrics
Eligibility
- Min Age
- 5 Years
- Max Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-02-01
- Primary Completion
- 2019-01-11
- Completion
- 2019-07-30
Countries
- Slovenia
Study Locations
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