Clinical trial NCT02586571: Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
Official title: Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adiposity
Body Composition, Beneficial
Growth Acceleration
Keywords: Body Composition
Breast Feeding
Growth
Infant
Milk, Human
Nutritional Sciences
Weaning
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Harvard Medical School (HMS and HSDM)
name: University College, London
First posted: 2015-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: At approximately 5 months of age, all infants in Iceland are invited to receive routine care (health checkup, immunization etc.) at the well-baby clinics at the primary health care centers in their neighbourhood. Nurses at well-baby clinics in and around Reykjavik cooperating with the study investigators screen all infants for eligibility according the eligibility criteria. Mothers of eligible infants receive oral and written information about the study and if interested, a written consent is obtained and study investigators are informed about the potential participant.

When the infant is around 5.5 months of age, the mother is contacted and a home visit by study investigators scheduled. In the home visit, more detailed information about the study is given and equipment for predose urine samples are given. The date for the first part of the study (day 0) is scheduled.

Day -1 and/or day 0: Mothers sample predose urine sample(s): 2x4 ml for group "Exclusive Breastfeeding A" and 1x2 ml for groups "Exclusive Breastfeeding B" and "Partial Breastfeeding".

Day 0 (home visit by investigators): Infant weighed, drinks 2.5 g/kg body weight + 1 g doubly labeled water or 0.7 g deuterium.

Mothers sample postdose urine samples: 6x4 ml for group "Exclusive Breastfeeding A" (days 1, 2, 3, 5, 6, 7) and 2x2 ml for the other groups (days 0+5 hours and day 2).

Mothers of infants in groups "Exclusive Breastfeeding B" and "Partial Breastfeeding" keep a 3-day weighed food record assessing their infants' diet including breast milk (by test weighing).

Day 7 (home visit by investigators): 2x10 ml breast milk samples (fore and hind milk) are obtained, questionnaires answered by mothers: background questionnaire, food frequency questionnaire on mother's habitual diet, the Baby Eating Behaviour Questionnaire (BEBQ) and the Infant Behaviour Questionnaire-Revised (IBQ-R).

At 9 months of age mothers keep a 3-day weighed food record assessing the infants' diet including breast milk if the infant is still breastfed (by test weighing).

At 12 months of age the primary outcome measure is assessed. Day -1 or day 0: Mothers sample predose urine sample: 1x2 ml. Day 0 (home visit by investigators): Infant weighed, drinks 1.2 g deuterium. Mothers sample postdose urine samples: 2x2 ml (days 0+5 hours and day 2). Mothers keep a 3-day weighed food record assessing their infants' diet including breast milk if the infant is still breastfed (by test weighing).

Mothers answer the Child Eating Behaviour Questionnaire (CEBQ).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Total body water measured by deuterium oxide
timeFrame: 12 months of age of child
Secondary outcomes:
measure: Metabolisable energy content of breast milk measured using doubly labelled water
timeFrame: 5.5 months of age of child
measure: Weight measured by infant scales
timeFrame: 0-12 months of age of child
measure: Length measured by calibrated lengthboards
timeFrame: 0-12 months of age of child
Other outcomes:
measure: Infant eating behavior assessed using Baby Eating Behaviour Questionnaire (BEBQ)
timeFrame: 5.5 months of age of child
measure: Infant temperament assessed using the Infant Behaviour Questionnaire-Revised (IBQ-R)
timeFrame: 5.5 months of age of child
measure: Leptin in breast milk
timeFrame: 5.5 months of age of child
measure: Ghrelin in breast milk
timeFrame: 5.5 months of age of child
measure: Cortisol in breast milk
timeFrame: 5.5 months of age of child
measure: Infant eating behavior assessed using Child Eating Behaviour Questionnaire (CEBQ)
timeFrame: 12 months of age of child
Locations:
Study officials:
affiliation: School of Social Sciences, University of Iceland
name: Geir Gunnlaugsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Health Sciences, University of Iceland
name: Inga Thorsdottir, PhD
role: STUDY_CHAIR
References:
citation: 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.