Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland

NCT02586571 | Completed

• 1 other identifier: IS-UI-IceAge2
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding among infants who are exclusively and partially breastfed at 6 months of age in terms of characteristics that are hypothesised to contribute to growth and development of body composition in infancy. The scientific originality lies in the simultaneous sampling of multiple factors that are believed to contribute to growth and development of body composition in infancy, i.e. energy content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament and appetite. The selection of two predefined study groups, i.e. infants exclusively breastfed until 6 months of age and infants given complementary foods in addition to breast-milk from 3-4 months of age, gives the opportunity to describe, and perhaps up to some point compare, what now is described by the World Health Organization and in official Icelandic infant recommendations as "optimal feeding" and what studies have suggested is "common feeding" in many countries. The methods are carefully chosen, i.e. appropriate and non-invasive isotopes and validated questionnaires are used. To our knowledge, no study has reported breast-milk composition in exclusively vs. partially breastfed infants.

Conditions

Adiposity; Body Composition, Beneficial; Growth Acceleration

Keywords

Body Composition; Breast Feeding; Growth; Infant; Milk, Human; Nutritional Sciences; Weaning

Outcome Measures

Primary Outcomes (1)

• Total body water measured by deuterium oxide

  Total body water measured by deuterium oxide and used to determine fat-free mass

  12 months of age of child

Secondary Outcomes (3)

• Metabolisable energy content of breast milk measured using doubly labelled water

  5.5 months of age of child

• Weight measured by infant scales

  0-12 months of age of child

• Length measured by calibrated lengthboards

  0-12 months of age of child

Other Outcomes (6)

• Infant eating behavior assessed using Baby Eating Behaviour Questionnaire (BEBQ)

  5.5 months of age of child

• Infant temperament assessed using the Infant Behaviour Questionnaire-Revised (IBQ-R)

  5.5 months of age of child

• Leptin in breast milk

  5.5 months of age of child

Study Arms (3)

Exclusive Breastfeeding A

Mother/infant pairs with exclusive breastfeeding up to 6 months of age. Secondary outcome measure 2 (Metabolisable energy content of breast milk) measured in this group only.

Behavioral: Breastfeeding

Exclusive Breastfeeding B

Mother/infant pairs with exclusive breastfeeding up to 6 months of age.

Behavioral: Breastfeeding

Partial Breastfeeding

Mother/infant pairs with partial breastfeeding along with complementary foods at 6 months of age.

Behavioral: Breastfeeding

Interventions

Breastfeeding BEHAVIORAL

Breastfeeding at 5.5 months of age (exclusive or partial)

Exclusive Breastfeeding A; Exclusive Breastfeeding B; Partial Breastfeeding

Eligibility Criteria

• Age: 5 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants receiving routine care at well-baby clinics at primary health care centers in and around Reykjavik, Iceland.

You may qualify if:

• Icelandic mother
• Singleton birth
• Gestational age 37-42 weeks
• Birth weight \>2500 g
• Living in Iceland until 12 months of age
• Only groups "Exclusive Breastfeeding A" and "Exclusive Breastfeeding B": Exclusively breastfed at 5.5 months of age (≤5 formula feedings and ≤5 water feedings since birth allowed)
• Only group "Partial Breastfeeding": Receiving at least 100 g / 100 ml of complementary foods (formula or solids) at 5.5 months of age

You may not qualify if:

• Diseases or defects likely to affect growth or body composition
• Not breastfed at 5.5 months of age

Sponsors & Collaborators

• University of Iceland: lead
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University College, London: collaborator

Related Publications (2)

• Thorisdottir B, Odinsdottir T, Gunnlaugsson G, Eaton S, Fewtrell MS, Vazquez-Vazquez A, Kleinman RE, Thorsdottir I, Wells JC. Metabolizable Energy Content of Breastmilk Supports Normal Growth in Exclusively Breastfed Icelandic Infants to Age 6 Months. Am J Clin Nutr. 2023 Aug;118(2):468-475. doi: 10.1016/j.ajcnut.2023.06.005. Epub 2023 Jun 13.

  PMID: 37369354 DERIVED

• Petersen E, Thorisdottir B, Thorsdottir I, Gunnlaugsson G, Arohonka P, Erlund I, Gunnarsdottir I. Iodine status of breastfed infants and their mothers' breast milk iodine concentration. Matern Child Nutr. 2020 Jul;16(3):e12993. doi: 10.1111/mcn.12993. Epub 2020 Mar 11.

  PMID: 32162412 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples will be obtained from all infants at 5.5 and 12 months of age. Breast milk samples will be obtained from all mothers when the child is 5.5 months of age.

MeSH Terms

Conditions

Obesity; Glucocorticoid Receptor Deficiency; Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Geir Gunnlaugsson, PhD

  School of Social Sciences, University of Iceland

  PRINCIPAL INVESTIGATOR

• Inga Thorsdottir, PhD

  School of Health Sciences, University of Iceland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2015
• First Posted: October 26, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11