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临床试验/NCT04076592
NCT04076592已完成不适用

Children Nutrition as a Protective or Health-risk Factor

University of Ljubljana1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Assessment of Nutritional Status of Children Using Dietary Pattern- Average Intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

研究概览

简要总结

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.

详细描述

Nutrition can act either as a risk or protective factor in the development of a series of non-communicable diseases. While such effects were established for the whole life cycle, the nutrition in early life may be particularly relevant for its long-term impact on later life health. The reliable scientific data on dietary intakes and nutritional status of the representing sample population serve as a basis to elucidate the role, the specific nutritional factors exert on human health. The scientific background of the proposed applicative research project is based on the fact that the studies, following the link between the early nutrition, initial intestinal microbiota, and development of children, over a longer time period, are limited. Therefore, the key scientific challenges addressed are focused on the effects of the early life nutrition on growth and health of participating children, and to investigate the relationship among various markers of health.

While the work programme of this multidisciplinary applicative prospective study will be focused onto children, it shall be tightly linked to former "My-Milk" project (SRA J43606; finished in the year 2013), where the role of early nutrition in the development of breast fed children and their intestinal microbiota, during the first year of life, was investigated. This study will be conducted within the population of 6-7 years olds included in the first "My-Milk" study. The study will characterize the key modifying factors during participant's early life (defined through maternal variables (BMI before pregnancy, weight gain during pregnancy, nutrition during pregnancy and lactation, fatty acid composition of human milk, and vitamin D concentration in serum) and infant variables (duration of breastfeeding and antibiotic treatments, faecal microbiota at first month, anthropometrics and bone mineral density in the neonatal period)) on participant's nutritional status at the age 6-7 years. The current nutritional status will be defined by participant's dietary intakes, anthropometrics, body composition - bone density, percentage of fat and muscle tissue), health (blood pressure, blood cholesterol, frequency and severity of infections), and fecal microbiota.

The study population invited to participate will include all singleton children of mothers who completed the detailed part of the My-Milk study at child's first year of age (N=147). Considering a very low drop-out rate in the first detailed part of the study My-Milk (33 participating mothers out of 185, approximately 18 percent), investigators expect that at least 70-75 percentage of the invited participants will respond, meaning between 100 - 110 children may get enrolled in the study. This population will represent 0,5 percentage of children born in 2011 (21947 children - statistical data for Slovenia).

The following parameters will be measured and evaluated: the nutrition of children by using the standard dietary assessment methodology for children and adults/elderly population as provided in the European Food Safety Authority guidance (EFSA). Namely, the food consumption survey will be carried out on the individual level by repeated 24-h food diary and Computer Assisted Personal/Telephone Interview method (CAPI/CATI) and by supporting General Questionnaire and the Food Propensity Questionnaire (FPQ) according to PANCAKE - Pilot study for the Assessment of Nutrient intake and Food Consumption Among Kids in Europe. The 24-h structured diet recall interview is a quantitative research method used in the nutritional assessment. A trained dietitian investigator will ask a parent or caretaker to recall all foods and drinks that the participating child consumed during the previous 24 hours at two different time points during the study (non-consecutive days at least 8 - 20 days between the two records) to receive the proper information about the habitual intake of foods. From the data obtained by 24-h recall investigators intend to evaluate nutritional intakes of the population sub-groups. In addition, connections between the nutrition of children and body composition and health markers will be studied. FPQ will enable the estimation of certain relevant, infrequently consumed food groups. Data will be collected using validated questionnaires using computer -assisted data collection methods and processing. Evaluation of the dietary intake data will be performed by dietary software Open Platform for Clinical Nutrition (OPEN) by Jožef Stefan Institute (IJS). OPEN is a web-based application for dietary assessment and treatment as well as upgraded to support the 24h -recall/food diary method and FPQs in line with the EFSA pan-European food consumption survey, also known as the EU Menu, methodology. OPEN is an efficient, first Slovenian web-based tool for dietary assessment based on the local food items. OPEN allows the dietitian to enter the food and amounts for each participant. After food items, amounts and preparations are entered into the OPEN, the program creates an analysis with the breakdown of nutritional information.

The assessment of growth, development, and health status in 6-7 years old participants will base on the conducted clinical examination and data obtained from the medical records. Clinical examination will include the assessment of clinical status, anthropometric measurements, and quantitative ultrasound measurements of the bone mineral density and measurement of blood pressure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Assessment of Nutritional Status of Children Using Dietary Pattern- Average Intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

时间窗: through study completion, an average of 1 year

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.

Assessment of Nutritional Status of Children Using Anthropometric Measurements- Skinfold Thickness

时间窗: through study completion, an average of 1 year

Skinfold thickness for biceps, triceps, subscapular, iliac crest, calf in mm.

Assessment of Nutritional Status of Children Using Fecal Microbiota

时间窗: through study completion, an average of 1 year

Fecal microbiota composition (expressed in percentages of relative abundances of represented amplicons of bacterial groups).

Assessment of Nutritional Status of Children Using Dietary Pattern- Average Nutrient Intake

时间窗: through study completion, an average of 1 year

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.

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

时间窗: through study completion, an average of 1 year

Frequency of infections and consumed antibiotics.

Assessment of Nutritional Status of Children Using Dietary Pattern- Energy Intake

时间窗: through study completion, an average of 1 year

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.

Assessment of Nutritional Status of Children Using Dietary Pattern- Adjusted Intake of Vitamin D

时间窗: through study completion, an average of 1 year

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.

Assessment of Nutritional Status of Children Using Dietary Pattern- Adjusted Micronutrients Intake

时间窗: through study completion, an average of 1 year

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.

Assessment of Nutritional Status of Children Using BMI

时间窗: through study completion, an average of 1 year

Body Mass Index calculated from weight/height\^2 in kg/m\^2.

Assessment of Nutritional Status of Children Using Anthropometric Measurements - Sitting Height, Leg Length and Circumferences

时间窗: through study completion, an average of 1 year

Sitting height, leg length -iliospinal, circumference for upper arm, waist, calf in cm.

Nutritional Status of Children Using Systolic and Diastolic Blood Pressure

时间窗: through study completion, an average of 1 year

Systolic and Diastolic Blood pressure in mmHg;

Assessment of Nutritional Status of Children Using Blood Cholesterol

时间窗: through study completion, an average of 1 year

Blood cholesterol in mg/dL

Assessment of Nutritional Status of Children Using Bone Density Measurements

时间窗: through study completion, an average of 1 year

Bone density in meters per second expressed as units of standard deviations relative to the mean for age- and sex-matched population reference values.

次要结局

  • Correlation Between Breastfeeding Length and BMI at age 7 years(through study completion, an average of 1 year)
  • 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 Frequency of Infections and Fecal Microbiota 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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