OTIS - Optimized Complementary Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However, current dietary recommendations to infants are based on traditions and experiences whereas research is basically lacking.
Towards the end of the first year of life the infant will normally become increasingly suspicious towards fruits and vegetables. However, these foods are an important part of healthy eating. When and how these food items should be introduced into the diet of young children is unclear.
New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger intake of fruits, vegetables, whole grain, fish and game. In adults such diet improves weight and biomarkers of insulin resistance and cardiovascular disease. Since dietary preferences are founded early in life it is logical to introduce such a diet already when the child is starting complementary foods.
In a randomized controlled study from 6 mo of age, we want to explore if a Nordic complementary diet with lower protein intake, more vegetable fats and a systematic introduction of fruits and greens will improve body composition, metabolic biomarkers, the composition of faecal microbiota (associated with obesity), cognitive development and the consumption of foods that can lay the foundation for better long-term diet. If the study has the expected results, these will have a direct impact on the dietary habits of Swedish children during infancy and childhood and thus their long-term health.
详细描述
Introduction Evidence is accumulating that early feeding affects health and development later in life. The positive effects of breast feeding are well known, but less is known on how different types and timing of complementary foods, i.e. the foods used during the transition from breastfeeding or formula-feeding to family foods affect short and long-term health. During the time of complementary feeding, the demands for energy and nutrients remain high, especially during the second half of the first year of life. We and others have shown a link between protein intake during this time period and later risk for overweight. Earlier studies have implicated very high protein intakes during infancy but the latest dietary recommendations for infants and children suggest lower intakes, which may have contributed to the decreasing prevalence of obesity seen in some countries. Early introduction of carbohydrate-rich complementary foods has also been associated to alterations leading to later obesity and insulin resistance. Finally, we and others have shown that higher intakes of polyunsaturated fatty acids and lower intakes of saturated fatty acids in the diet of infants improve blood lipids and that these influences track into childhood.
The composition of the complementary food is important also from the perspective of food flavour, texture and presentation. Experiences of flavour during foetal and breast feeding period prime the newborn infant to accept the same types of foods as the mother usually takes, including foods with flavours outside the normal preferences of the infant, i.e. sweet, salty and fatty. Also the acceptance of different textures of foods changes during the infancy year. As the oral motor skills of the infant develop, the child is able to handle increasingly lumpy and solid foods. A normally developing infant will have periods of greater acceptance of novel foods both in terms of flavour and texture, usually coinciding with the time when complementary foods are introduced. However, this window of opportunity to introduce new foods begins to close around 10-12 mo. of age, when the child grows increasingly suspicious of unfamiliar tastes, i.e. food neophobia, but also, if solids haven't been introduced at this time, to the texture of common food items. Studies have shown that the types and numbers of different foods that a child accepts can be influenced by the manner and frequency of how they are introduced during this time. Numerous studies have shown that fruits and vegetables are an important part of healthy eating habits in all ages, but that the actual intake of these food items among young children is low. Instead, population-based studies from Sweden have shown that the dietary intake of children is not satisfactory from a public health perspective, with intakes of refined sugars, fatty foods and salt being too high and intakes of fruits and vegetables being too low.
In 2005 the Nordic Council of Ministers launched the New Nordic Food programme. This initiative highlights the health, gastronomic and sustainability aspects of foods produced within the Nordic region. Compared to the regular Swedish diet, the Nordic diet (ND) stresses higher intakes of regionally produced fruits, berries, vegetables, tubers, and legumes, higher intakes of whole-wheat, vegetable fats and oils, fish and egg, and lower intake of sweets, desserts and dairy, meat and poultry products, but at the same time being in line with current dietary recommendations. In adults, studies on ND have shown beneficial effects on weight and metabolic and cardiovascular disease markers of the same magnitude as e.g. the Mediterranean diet.
We aim to improve body composition, metabolic markers and the faecal microbiota composition of young children by using ND as a basis for complementary foods, with its emphasis on regionally produced fruits, berries, vegetables, tubers and legumes, also increasing the intake of fish and vegetable fats and oils, particularly using rapeseed oil but decreasing total protein intake. Effects on faecal microbiota composition have been a proposed pathway linking early dietary intake with later metabolic outcomes.
Relevance The early diet has longstanding effects on human health. Apart from breastfeeding little is known on which infant diets would confer long-term health benefits. ND has several potential advantages in this respect, and studies in adults have shown favourable effects on metabolic and cardiovascular disease markers and mortality similar to those gained through the Mediterranean diet. The present study, using ND as the basis for complementary foods but also reducing the total protein intake, improving fatty acid composition and expanding the introduction of fruits and vegetables into the diet of small children is the first study of its kind and will add vital information in the search to prevent obesity, dyslipidaemia, insulin resistance, type 2 diabetes, hypertension and cardiovascular disease and will have implications for future national and international dietary recommendations to young children. Through early intervention, i.e. already when complementary foods are introduced into the diet of the infant, we believe that we can initiate healthy food preferences from the earliest date thus maximizing the long-term public health benefits of healthy eating. By adopting the concept of ND we will also add gastronomical aspects to the development of optimal complementary foods as well as support regional food production and contribute to a sustainable environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 18 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, singleton infants 4-6 mo. of age
- •>37 weeks of gestation at birth
- •Birth weight >2500 g
- •Available throughout the study period, i.e. the participant will remain in the study area (Umeå municipality) and will not commence child care outside the home during the extent of the study, i.e. until 18 mo. of age.
- •Parents or legal guardians are able to give written informed consent to participation in the study.
排除标准
- •Children with chronic illnesses that will affect feeding or growth, including food allergies or intolerance to study products
- •Intake of any complementary food at recruitment
- •Use of supplements or medications that will affect the study outcomes
- •Iron deficiency (Hb <105 g/L, S-ferritin <12 µg/L) or any other biochemical abnormality discovered at the baseline examination that needs medical attention after decision by the study physician.
- •Repeated non-adherence to key study procedures including anthropometric measurements, allergy, eczema and symptoms registrations
研究组 & 干预措施
Nordic diet
The participant in the Nordic diet group will experience three interventions: a) a systematic introduction of taste portions, b) Protein reduced complementary foods (milk cereal drinks, porridge and baby milk with reduced protein content), and c) homemade and industry manufactured main meals with a predominance of Nordic ingredients.
干预措施: Systematic introduction of taste portions (Other)
Nordic diet
The participant in the Nordic diet group will experience three interventions: a) a systematic introduction of taste portions, b) Protein reduced complementary foods (milk cereal drinks, porridge and baby milk with reduced protein content), and c) homemade and industry manufactured main meals with a predominance of Nordic ingredients.
干预措施: Protein reduced complementary foods (Other)
Nordic diet
The participant in the Nordic diet group will experience three interventions: a) a systematic introduction of taste portions, b) Protein reduced complementary foods (milk cereal drinks, porridge and baby milk with reduced protein content), and c) homemade and industry manufactured main meals with a predominance of Nordic ingredients.
干预措施: Nordic diet (Other)
Regular diet
The participants will be given the current advice on infant feeding issued by the Swedish National Food Agency. They will also be given regular, commercially available milk cereal drinks, porridge, baby milk and industry manufactured main meals. No advice or recipes on meals will be given apart from the current recommendations.
结局指标
主要结局
Body composition
时间窗: 18 mo. of age
Total body water (TBW) as a measure of body composition (3 compartment model) will be determined at 18 months of age. TBW will be assessed using deuterium (2H2O) in collaboration with the MRC Human Nutrition Research Laboratory, Cambridge, UK.
Body composition
时间窗: 12 mo. of age
Total body water (TBW) as a measure of body composition (3 compartment model) will be determined at 12 months of age. TBW will be assessed using deuterium (2H2O) in collaboration with the MRC Human Nutrition Research Laboratory, Cambridge, UK.
次要结局
- Faecal microbiota composition(18 mo. of age)
- Oral microbiota composition(18 mo. of age)
- Blood pressure(18 mo. of age)
- Acceptance of test meal(18 mo. of age)
- Body mass index(18 mo. of age)
- Dietary intake(18 mo. of age)
- Allergy and atopic manifestations(18 mo. of age)
- Psychological development (ASQ)(18 mo. of age)
- Biomarkers of adherence(18 mo. of age)
- Psychological development (free play)(18 mo. of age)
- Biomarkers of metabolic function(18 mo. of age)
- Dietary intake(9 mo. of age)
- Dietary intake(12 mo. of age)
- Biomarkers of adherence(9 mo. of age)
- Biomarkers of adherence(12 mo. of age)
- Allergy and atopic manifestations(9 mo. of age)
- Allergy and atopic manifestations(12 mo. of age)
- Psychological development (ASQ)(12 mo. of age)
- Psychological development (free play)(12 mo. of age)
- Biomarkers of metabolic function(9 mo. of age)
- Biomarkers of metabolic function(12 mo. of age)
- Faecal microbiota composition(12 mo. of age)
- Oral microbiota composition(12 mo. of age)
- Blood pressure(12 mo. of age)
- Acceptance of test meal(12 mo. of age)
- Body mass index(12 mo. of age)
研究者
Torbjörn Lind
Associate Professor
Umeå University
