Breastfeeding Clinical Trial
— My-Milk-2Official title:
Children Nutrition as a Protective or Health-risk Factor
Verified date | September 2019 |
Source | University of Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | July 30, 2019 |
Est. primary completion date | January 11, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
Inclusion Criteria: - all singleton children and their mothers who have completed a detailed part of the My-Milk study (N=147) will be invited in this follow-up study. Exclusion Criteria: / |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University of Ljubljana | University Medical Centre Ljubljana |
Slovenia,
Dodd KW, Guenther PM, Freedman LS, Subar AF, Kipnis V, Midthune D, Tooze JA, Krebs-Smith SM. Statistical methods for estimating usual intake of nutrients and foods: a review of the theory. J Am Diet Assoc. 2006 Oct;106(10):1640-50. Review. — View Citation
Farmer G. Neonatal skinfold thickness. Measurement and interpretation at or near term. Arch Dis Child. 1985 Sep;60(9):840-2. — View Citation
Obermajer T, Grabnar I, Benedik E, Tušar T, Robic Pikel T, Fidler Mis N, Bogovic Matijašic B, Rogelj I. Microbes in Infant Gut Development: Placing Abundance Within Environmental, Clinical and Growth Parameters. Sci Rep. 2017 Sep 11;7(1):11230. doi: 10.10 — View Citation
Subar AF, Dodd KW, Guenther PM, Kipnis V, Midthune D, McDowell M, Tooze JA, Freedman LS, Krebs-Smith SM. The food propensity questionnaire: concept, development, and validation for use as a covariate in a model to estimate usual food intake. J Am Diet Assoc. 2006 Oct;106(10):1556-63. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Nutritional Status of Children Using Dietary Pattern- Energy Intake | Habitual energy intake per day in kilocalories (kcal): calculated online with the software OPEN platform having integrated Slovenian food database, from child's 24-hour dietary recalls (of food items ingested) on two non-consecutive days. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Dietary Pattern- Average Nutrient Intake | An average intake of carbohydrates, total sugar, free sugar, starch, dietary fibres, fat, fatty acids, proteins per day in percentages: calculated online with the software OPEN platform having integrated Slovenian food database, from child's 24-hour dietary recalls (of food items ingested) on two non-consecutive days. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Dietary Pattern- Average Intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) | An average intake of adjusted eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day in grams: calculated online with the software OPEN platform having integrated Slovenian food database, from child's 24-hour dietary recalls (of food items ingested) on two non-consecutive days. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Dietary Pattern- Adjusted Intake of Vitamin D | An adjusted vitamin D and folic acid intake per day in micrograms: calculated online with the software OPEN platform having integrated Slovenian food database, from child's 24-hour dietary recalls (of food items ingested) on two non-consecutive days. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Dietary Pattern- Adjusted Micronutrients Intake | An adjusted natrium, chlorine, calcium and iron in milligrams: calculated online with the software OPEN platform having integrated Slovenian food database, from child's 24-hour dietary recalls (of food items ingested) on two non-consecutive days. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using BMI | Body Mass Index calculated from weight/height^2 in kg/m^2. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Anthropometric Measurements - Sitting Height, Leg Length and Circumferences | Sitting height, leg length -iliospinal, circumference for upper arm, waist, calf in cm. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Anthropometric Measurements- Skinfold Thickness | Skinfold thickness for biceps, triceps, subscapular, iliac crest, calf in mm. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Bone Density Measurements | Bone density in meters per second expressed as units of standard deviations relative to the mean for age- and sex-matched population reference values. | through study completion, an average of 1 year | |
Primary | Nutritional Status of Children Using Systolic and Diastolic Blood Pressure | Systolic and Diastolic Blood pressure in mmHg; | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Blood Cholesterol | Blood cholesterol in mg/dL | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Morbidity (Sickness Frequency) | Frequency of infections and consumed antibiotics. | through study completion, an average of 1 year | |
Primary | Assessment of Nutritional Status of Children Using Fecal Microbiota | Fecal microbiota composition (expressed in percentages of relative abundances of represented amplicons of bacterial groups). | through study completion, an average of 1 year | |
Secondary | Changes in BMI from first year till 7th year of life | Changes in BMI-weight/height^2 in kg/m^2 (expressed as units of standard deviations relative to the mean for age- and sex-matched population reference values) | from first year data till 7th year of life | |
Secondary | Changes in Bone Density from first year till 7th year of life | Changes in bone density in meters per second (expressed as units of standard deviations relative to the mean for age- and sex-matched population reference values). | from first year data till 7th year of life | |
Secondary | Correlation Early Feeding and BMI at age 7 years | Correlations (expressed as Spearman, Pearson, etc. coefficients) in association study between the type of early feeding (exclusive breastfeeding vs formula supplementation) and BMI-weight/height^2 in kg/m^2. | through study completion, an average of 1 year | |
Secondary | Correlation Between Breastfeeding Length and BMI at age 7 years | Correlations (expressed as Spearman, Pearson, etc. coefficients) in association study between the length of breastfeeding (in months) and BMI- weight/height^2 in kg/m^2. | through study completion, an average of 1 year | |
Secondary | Correlation Between Breastfeeding Length and Bone Density at age 7 years | Correlations (expressed as Spearman, Pearson, etc. coefficients) in association study between the length of breastfeeding (in months) and bone density in meters per second. | through study completion, an average of 1 year | |
Secondary | Correlation Between Frequency of Infections and Fecal Microbiota at age 7 years | Correlations (expressed as Spearman, Pearson, etc. coefficients) in association study between frequency of infections and fecal microbiota composition. | through study completion, an average of 1 year |
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