Infant Development Clinical Trial
— OTISOfficial title:
OTIS - Optimized Complementary Feeding Study
Verified date | April 2019 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | April 15, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Months to 18 Months |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Paediatrics, Department of Clinical Sciences | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | MRC Human Nutrition Research, Semper AB, University of California |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence of bitter taste receptor gene hTAS2R28 | Saliva samples at baseline | Baseline | |
Other | Temperament | Child temperament will be assessed with the Swedish versions of the Toddler Behaviour Questionnaire (TBQ) at 18 mo. of age. | 18 mo. of age | |
Primary | Body composition | 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. | 12 mo. of age | |
Primary | Body composition | 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. | 18 mo. of age | |
Secondary | Dietary intake | At 9 mo. of age the parents will be asked to register the participating child's intake of foods and drinks during consecutive 5 days. | 9 mo. of age | |
Secondary | Dietary intake | At 12 mo. of age the parents will be asked to register the participating child's intake of foods and drinks during consecutive 5 days. They will also be asked to photograph the child's meal portions just before the meal is served and right after, taking 2 photos each time from perpendicular angles. | 12 mo. of age | |
Secondary | Dietary intake | At 18 mo. of age the parents will be asked to register the participating child's intake of foods and drinks during consecutive 5 days. They will also be asked to photograph the child's meal portions just before the meal is served and right after, taking 2 photos each time from perpendicular angles. | 18 mo. of age | |
Secondary | Biomarkers of adherence | Blood samples will be collected for haemoglobin, iron status, P-urea, vitamins C, A, E, carotenoids, folic acid, cow's milk specific C15 and C17 fatty acids as secondary outcomes and markers of adherence. | 9 mo. of age | |
Secondary | Biomarkers of adherence | Blood samples will be collected for haemoglobin, iron status, P-urea, vitamins C, A, E, carotenoids, folic acid, cow's milk specific C15 and C17 fatty acids as secondary outcomes and markers of adherence. | 12 mo. of age | |
Secondary | Biomarkers of adherence | Blood samples will be collected for haemoglobin, iron status, P-urea, vitamins C, A, E, carotenoids, folic acid, cow's milk specific C15 and C17 fatty acids as secondary outcomes and markers of adherence. | 18 mo. of age | |
Secondary | Allergy and atopic manifestations | At 9 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema. | 9 mo. of age | |
Secondary | Allergy and atopic manifestations | At 12 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema. | 12 mo. of age | |
Secondary | Allergy and atopic manifestations | At 18 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema. | 18 mo. of age | |
Secondary | Psychological development (ASQ) | The Ages and Stages Questionnaire (ASQ) will be administered at 12 mo. of age as a measure of general development. | 12 mo. of age | |
Secondary | Psychological development (free play) | A videotaped single object free play task, as a measurement of cognitive development in relation to the nutritional intervention will be administered at 12 mo. of age. | 12 mo. of age | |
Secondary | Psychological development (ASQ) | The Ages and Stages Questionnaire (ASQ) will be administered at 18 mo. of age as a measure of general development. | 18 mo. of age | |
Secondary | Psychological development (free play) | A videotaped single object free play task, as a measurement of cognitive development in relation to the nutritional intervention will be administered at 18 mo. of age. | 18 mo. of age | |
Secondary | Biomarkers of metabolic function | Blood and urine samples will be collected for a number of biomarkers associated with metabolic function including plasma (P-) insulin, P-glucose, P-IGF-1, P-lipids and lipoproteins, P-fatty acids including LC-PUFAs (DHA, EPA, ARA), hsCRP, oxidative capacity, metabolomics and lipidomics. | 9 mo. of age | |
Secondary | Biomarkers of metabolic function | Blood and urine samples will be collected for a number of biomarkers associated with metabolic function including plasma (P-) insulin, P-glucose, P-IGF-1, P-lipids and lipoproteins, P-fatty acids including LC-PUFAs (DHA, EPA, ARA), hsCRP, oxidative capacity, metabolomics and lipidomics. | 12 mo. of age | |
Secondary | Biomarkers of metabolic function | Blood and urine samples will be collected for a number of biomarkers associated with metabolic function including plasma (P-) insulin, P-glucose, P-IGF-1, P-lipids and lipoproteins, P-fatty acids including LC-PUFAs (DHA, EPA, ARA), hsCRP, oxidative capacity, metabolomics and lipidomics. | 18 mo. of age | |
Secondary | Faecal microbiota composition | Overall faecal microbiota composition using 16S rDNA analysis | 12 mo. of age | |
Secondary | Oral microbiota composition | Overall oral microbiota composition using 16S rDNA analysis | 12 mo. of age | |
Secondary | Faecal microbiota composition | Overall faecal microbiota composition using 16S rDNA analysis | 18 mo. of age | |
Secondary | Oral microbiota composition | Overall oral microbiota composition using 16S rDNA analysis | 18 mo. of age | |
Secondary | Blood pressure | Blood pressure will be measured with the child sitting in the parent's lap using a Carescape Dinamap V100 monitor (GE Healthcare AB, Sweden) and age appropriate blood pressure cuffs. At baseline, the parents' blood pressure will be collected sitting, using the same equipment as described above. | 12 mo. of age | |
Secondary | Blood pressure | Blood pressure will be measured with the child sitting in the parent's lap using a Carescape Dinamap V100 monitor (GE Healthcare AB, Sweden) and age appropriate blood pressure cuffs. At baseline, the parents' blood pressure will be collected sitting, using the same equipment as described above. | 18 mo. of age | |
Secondary | Acceptance of test meal | A video-taped test meal to assess acceptability of new foods will be administered at 12 mo. of age. During the meal the parent will serve a mid-day snack (a fruit-flavoured yoghurt, a fruit-flavoured milk and a cracker with a vegetable spread) to the child. | 12 mo. of age | |
Secondary | Acceptance of test meal | A video-taped test meal to assess acceptability of new foods will be administered at 18 mo. of age. During the meal the parent will serve a mid-day snack (a fruit-flavoured yoghurt, a fruit-flavoured milk and a cracker with a vegetable spread) to the child. | 18 mo. of age | |
Secondary | Body mass index | Body mass index will be calculated from weight and length and assessed at 12 mo. of age | 12 mo. of age | |
Secondary | Body mass index | Body mass index will be calculated from weight and length and assessed at 18 mo. of age | 18 mo. of age |
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