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OTIS - Optimized Complementary Feeding Study (OTIS)

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ClinicalTrials.gov Identifier: NCT02634749
Recruitment Status : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Semper AB
University of California
MRC Human Nutrition Research
Information provided by (Responsible Party):
Torbjörn Lind, Umeå University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infant Development Body Composition, Beneficial Dietary Modification Other: Systematic introduction of taste portions Other: Protein reduced complementary foods Other: Nordic diet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: OTIS - Optimized Complementary Feeding Study
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : January 24, 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: 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.
Other: Systematic introduction of taste portions
A systematic introduction of plant foods from the Nordic diet

Other: Protein reduced complementary foods
Specially prepared, protein-reduced, age-adjusted milk cereal drinks, baby cereals and baby milk, and commercially available baby foods in glass jars

Other: Nordic diet
Taste portions, homemade and industry manufactured main meals with a predominance of Nordic ingredients

No Intervention: 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.



Primary Outcome Measures :
  1. Body composition [ Time Frame: 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.

  2. Body composition [ Time Frame: 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.


Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: 9 mo. of age ]
    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.

  2. Dietary intake [ Time Frame: 12 mo. of age ]
    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.

  3. Dietary intake [ Time Frame: 18 mo. of age ]
    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.

  4. Biomarkers of adherence [ Time Frame: 9 mo. of age ]
    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.

  5. Biomarkers of adherence [ Time Frame: 12 mo. of age ]
    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.

  6. Biomarkers of adherence [ Time Frame: 18 mo. of age ]
    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.

  7. Allergy and atopic manifestations [ Time Frame: 9 mo. of age ]
    At 9 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema.

  8. Allergy and atopic manifestations [ Time Frame: 12 mo. of age ]
    At 12 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema.

  9. Allergy and atopic manifestations [ Time Frame: 18 mo. of age ]
    At 18 mo. of age the participants will in a questionnaire be asked for symptoms of allergy, asthma, atopic disease and eczema.

  10. Psychological development (ASQ) [ Time Frame: 12 mo. of age ]
    The Ages and Stages Questionnaire (ASQ) will be administered at 12 mo. of age as a measure of general development.

  11. Psychological development (free play) [ Time Frame: 12 mo. of age ]
    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. Psychological development (ASQ) [ Time Frame: 18 mo. of age ]
    The Ages and Stages Questionnaire (ASQ) will be administered at 18 mo. of age as a measure of general development.

  13. Psychological development (free play) [ Time Frame: 18 mo. of age ]
    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.

  14. Biomarkers of metabolic function [ Time Frame: 9 mo. of age ]
    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.

  15. Biomarkers of metabolic function [ Time Frame: 12 mo. of age ]
    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.

  16. Biomarkers of metabolic function [ Time Frame: 18 mo. of age ]
    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.

  17. Faecal microbiota composition [ Time Frame: 12 mo. of age ]
    Overall faecal microbiota composition using 16S rDNA analysis

  18. Oral microbiota composition [ Time Frame: 12 mo. of age ]
    Overall oral microbiota composition using 16S rDNA analysis

  19. Faecal microbiota composition [ Time Frame: 18 mo. of age ]
    Overall faecal microbiota composition using 16S rDNA analysis

  20. Oral microbiota composition [ Time Frame: 18 mo. of age ]
    Overall oral microbiota composition using 16S rDNA analysis

  21. Blood pressure [ Time Frame: 12 mo. of age ]
    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.

  22. Blood pressure [ Time Frame: 18 mo. of age ]
    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.

  23. Acceptance of test meal [ Time Frame: 12 mo. of age ]
    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.

  24. Acceptance of test meal [ Time Frame: 18 mo. of age ]
    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.

  25. Body mass index [ Time Frame: 12 mo. of age ]
    Body mass index will be calculated from weight and length and assessed at 12 mo. of age

  26. Body mass index [ Time Frame: 18 mo. of age ]
    Body mass index will be calculated from weight and length and assessed at 18 mo. of age


Other Outcome Measures:
  1. Prevalence of bitter taste receptor gene hTAS2R28 [ Time Frame: Baseline ]
    Saliva samples at baseline

  2. Temperament [ Time Frame: 18 mo. of age ]
    Child temperament will be assessed with the Swedish versions of the Toddler Behaviour Questionnaire (TBQ) at 18 mo. of age.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634749


Locations
Sweden
Paediatrics, Department of Clinical Sciences
Umeå, Sweden, 90185
Sponsors and Collaborators
Umeå University
Semper AB
University of California
MRC Human Nutrition Research
Investigators
Principal Investigator: Torbjörn Lind, Ass prof Umeå University

Responsible Party: Torbjörn Lind, Associate Professor, Umeå University
ClinicalTrials.gov Identifier: NCT02634749     History of Changes
Other Study ID Numbers: Umu_2014-363-31
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Torbjörn Lind, Umeå University:
Nordic countries
Eating behavior
Human microbiome
Child nutrition
Metabolic profile
Body composition