NUTRIPROTECT-Children Nutrition as a Protective or Health-risk Factor

NCT04076592 | Completed

• 1 other identifier: L3 8213 BF-UL My-Milk-2
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nutritional Intake,; Child Growth and Development; Bone Density; Antibiotics

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Assessment of Nutritional Status of Children Using Blood Cholesterol

  Blood cholesterol in mg/dL

  through study completion, an average of 1 year

• Assessment of Nutritional Status of Children Using Morbidity (Sickness Frequency)

  Frequency of infections and consumed antibiotics.

  through study completion, an average of 1 year

• 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 Outcomes (6)

• Changes in BMI from first year till 7th year of life

  from first year data till 7th year of life

• Changes in Bone Density from first year till 7th year of life

  from first year data till 7th year of life

• Correlation Early Feeding and BMI at age 7 years

  through study completion, an average of 1 year

• Correlation Between Breastfeeding Length and BMI at age 7 years

  through study completion, an average of 1 year

• Correlation Between Breastfeeding Length and Bone Density at age 7 years

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All singleton children and their mothers who have completed a detailed part of the My-Milk study 1 (147) will be invited in this prospective follow-up study.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Ljubljana: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology

Ljubljana, 1000, Slovenia

Location

Related Publications (4)

• 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. doi: 10.1016/j.jada.2006.07.011.

  PMID: 17000197 BACKGROUND

• 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. doi: 10.1016/j.jada.2006.07.002.

  PMID: 17000188 BACKGROUND

• Farmer G. Neonatal skinfold thickness. Measurement and interpretation at or near term. Arch Dis Child. 1985 Sep;60(9):840-2. doi: 10.1136/adc.60.9.840.

  PMID: 4051541 BACKGROUND

• Obermajer T, Grabnar I, Benedik E, Tusar T, Robic Pikel T, Fidler Mis N, Bogovic Matijasic 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: 10.1038/s41598-017-10244-x.

  PMID: 28894126 RESULT

Related Links

• OPEN: Open Platform for Clinical Nutrition, Available 04.03.2015
• Zekan et al. (1999): Predictive factors in determination of newborn weight

Biospecimen

Retention: SAMPLES WITH DNA

child's feces

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Irena Rogelj, Prof., PhD

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

• Rok Orel, MD, Prof., PhD

  University Medical Centre Ljubljana, Division of Pediatrics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: September 3, 2019
• Study Start: February 1, 2018
• Primary Completion: January 11, 2019
• Study Completion: July 30, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

SL (1)