AdiposityIceAge2NCT02586571
Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
An observational study of Adiposity and Body Composition, Beneficial, run by University of Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 months
- Conditions the study is for
- Adiposity, Body Composition, Beneficial, Growth Acceleration
- What is being tested?
- Breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants receiving routine care at well-baby clinics at primary health care centers in and around Reykjavik, Iceland.
Who may be able to join
- 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
Who cannot join
- Diseases or defects likely to affect growth or body composition
- Not breastfed at 5.5 months of age
About this study
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.
Read the 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).
- Conditions
- Adiposity, Body Composition, Beneficial, Growth Acceleration
- Being tested
- Breastfeeding
- Keywords
- Body Composition, Breast Feeding, Growth, Infant, Milk, Human, Nutritional Sciences, Weaning
- Medical subject headings
- Obesity, Glucocorticoid Receptor Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingBehavioural
Breastfeeding at 5.5 months of age (exclusive or partial)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breastfeeding | |
| Exclusive Breastfeeding B | Mother/infant pairs with exclusive breastfeeding up to 6 months of age. Receives: Behavioral: Breastfeeding | |
| Partial Breastfeeding | Mother/infant pairs with partial breastfeeding along with complementary foods at 6 months of age. Receives: Behavioral: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body water measured by deuterium oxide
Total body water measured by deuterium oxide and used to determine fat-free mass
Measured: 12 months of age of child
Secondary outcomes (3)
Metabolisable energy content of breast milk measured using doubly labelled water
Measured using doubly labelled water (this outcome only measured in group labeled 'Exclusive Breastfeeding A')
Measured: 5.5 months of age of child
Weight measured by infant scales
Weight measured by infant scales
Measured: 0-12 months of age of child
Length measured by calibrated lengthboards
Length measured by calibrated lengthboards
Measured: 0-12 months of age of child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University College, London
- Responsible party
- Principal investigator, Geir Gunnlaugsson, University of Iceland
- Investigators
- Geir Gunnlaugsson, PhD, Principal investigator, School of Social Sciences, University of IcelandInga Thorsdottir, PhD, Study chair, School of Health Sciences, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586571
- Sponsor's protocol ID
- IS-UI-IceAge2
- Acronym
- IceAge2
- Status last verified
- Nov 2020
- First submitted
- 4 Oct 2015
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37369354Petersen 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.
PubMed 32162412
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
- ClinicalTrials.gov ID
- NCT02586571
- Acronym / sponsor ID
- IceAge2 / IS-UI-IceAge2
- Conditions
- Adiposity, Body Composition, Beneficial, Growth Acceleration
- Keywords
- Body Composition, Breast Feeding, Growth, Infant, Milk, Human, Nutritional Sciences, Weaning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University College, London
- Study start
- Dec 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exclusive Breastfeeding A | – | Behavioral: BreastfeedingMother/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. |
| Exclusive Breastfeeding B | – | Behavioral: BreastfeedingMother/infant pairs with exclusive breastfeeding up to 6 months of age. |
| Partial Breastfeeding | – | Behavioral: BreastfeedingMother/infant pairs with partial breastfeeding along with complementary foods at 6 months of age. |
Who may qualify
- Ages
- 5 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants receiving routine care at well-baby clinics at primary health care centers in and around Reykjavik, Iceland.
Key inclusion criteria (7 listed)
- Icelandic mother
- Singleton birth
- Gestational age 37-42 weeks
- Birth weight >2500 g
- Living in Iceland until 12 months of age
Key exclusion criteria (2 listed)
- Diseases or defects likely to affect growth or body composition
- Not breastfed at 5.5 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastfeedingBreastfeeding at 5.5 months of age (exclusive or partial) | Behavioural | Exclusive Breastfeeding A, Exclusive Breastfeeding B, Partial Breastfeeding |
Primary outcome
Total body water measured by deuterium oxide
Time frame: 12 months of age of child
Total body water measured by deuterium oxide and used to determine fat-free mass
3 secondary outcomes
Metabolisable energy content of breast milk measured using doubly labelled water
Time frame: 5.5 months of age of child
Weight measured by infant scales
Time frame: 0-12 months of age of child
Length measured by calibrated lengthboards
Time frame: 0-12 months of age of child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 37369354Thorisdottir 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.
- Derived from this study: PubMed 32162412Petersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Gunnlaugsson, PhD principal investigator
School of Social Sciences, University of Iceland
Inga Thorsdottir, PhD study chair
School of Health Sciences, University of Iceland
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity and Body Composition, Beneficial, run by University of Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body water measured by deuterium oxide (time frame: 12 months of age of child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.