OTIS - Optimized Complementary Feeding Study

NCT02634749 | Completed

• 1 other identifier: Umu_2014-363-31
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development; Body Composition, Beneficial; Dietary Modification

Keywords

Nordic countries; Eating behavior; Human microbiome; Child nutrition; Metabolic profile; Body composition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (26)

• Dietary intake

  9 mo. of age

• Dietary intake

  12 mo. of age

• Dietary intake

  18 mo. of age

• Biomarkers of adherence

  9 mo. of age

• Biomarkers of adherence

  12 mo. of age

Other Outcomes (2)

• Prevalence of bitter taste receptor gene hTAS2R28

  Baseline

• Temperament

  18 mo. of age

Study Arms (2)

Nordic diet

EXPERIMENTAL

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; Other: Protein reduced complementary foods; Other: Nordic diet

Regular diet

NO INTERVENTION

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.

Interventions

Systematic introduction of taste portions OTHER

A systematic introduction of plant foods from the Nordic diet

Nordic diet

Protein reduced complementary foods OTHER

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

Nordic diet

Nordic diet OTHER

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

Nordic diet

Eligibility Criteria

• Age: 4 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Semper AB: collaborator
• University of California: collaborator
• MRC Human Nutrition Research: collaborator

Study Sites (1)

Paediatrics, Department of Clinical Sciences

Umeå, 90185, Sweden

Location

Related Publications (2)

• Johansson U, Ohlund I, Lindberg L, Hernell O, Lonnerdal B, Venables M, Lind T. A randomized, controlled trial of a Nordic, protein-reduced complementary diet in infants: effects on body composition, growth, biomarkers, and dietary intake at 12 and 18 months. Am J Clin Nutr. 2023 Jun;117(6):1219-1231. doi: 10.1016/j.ajcnut.2023.03.020. Epub 2023 Mar 27.

  PMID: 36990225 DERIVED

• Lind T, Johansson U, Ohlund I, Lindberg L, Lonnerdal B, Tennefors C, Hernell O. Study protocol: optimized complementary feeding study (OTIS): a randomized controlled trial of the impact of a protein-reduced complementary diet based on Nordic foods. BMC Public Health. 2019 Jan 31;19(1):134. doi: 10.1186/s12889-019-6466-1.

  PMID: 30704429 DERIVED

MeSH Terms

Conditions

Glucocorticoid Receptor Deficiency; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Torbjörn Lind, Ass prof

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: December 18, 2015
• Study Start: April 1, 2015
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

SE (1)