ObesityNCT02535637
Breastfeeding and Obesity on Offspring Body Composition
An observational study of Obesity and Breast Milk Collection, run by University of Oklahoma.
Trial summary
The purpose of this study is to explore the effect maternal obesity and breastfeeding play on infant body composition. The investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than… Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Breast Milk Collection
- What is being tested?
- Exclusively breastfeed
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Feb 2012
- 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 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 37 mothers whom exclusively breast fed to six-months. Participants (mothers/infant) included offspring from mothers with a singleton-term healthy pregnancy (37-40 weeks). Both vaginal and cesarean deliveries were included. Infants who are exclusively breastfed (defined as no formula in the last 20 days) prior to enrollment will be considered.
Who may be able to join
- Gestational age between 37 and 41 weeks
- Singleton birth
- Infant in good health
- 40±5 days old at enrollment
- Infant is being exclusively breastfed (defined as fed directly from the breast or with mother's expressed milk and receiving no formula in the last 20 days prior to enrollment)
- Mother of an infant being exclusively breastfed plans to continue this exclusive feeding from the time of enrollment until six months of age
- Parent/caregiver demonstrates an understanding of the given information and ability to record the requested data
- Having obtained informed consent of legal representative
Who cannot join
- Congenital illness or malformation that affects infant feeding and/or growth
- Significant pre-natal and/or post-natal disease
- Infant has received any complementary feeding, i.e. any nutrition besides breast milk
- In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- Currently participating in another clinical trial
About this study
Official title: Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age
The purpose of this study is to explore the effect maternal obesity and breastfeeding play on infant body composition. The investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than breast fed infants from normal weight mothers. Furthermore, the investigators postulate that circulating maternal milk adipocytokines will positively correlate to total fat mass at six months of age.
Read the detailed description
The objective of this study is to determine if offspring from overweight/obese non-diabetic mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at a greater rate from ~ 1 month to 6 months of life compared to breastfed infants from normal weight mothers.
Specific Aim 1: Understand how maternal obesity and breast-feeding impact body composition of the offspring. Based upon the investigators preliminary data and counter to accepted dogma the hypothesis is at six months of age total fat mass, particularly in the trunk will be elevated at 6 months of age in infants whose mother was either overweight or obese vs. infants from normal weight mothers.
Specific Aim 2: Identify adipocytokines in breast milk. The postulate is breast milk from overweight and obese mothers will have greater levels of insulin, glucose, Ghrelin, IGF-1, IL-6, TNFα, high-sensitivity C-reactive protein, and lower Leptin levels than breast milk from normal weight mothers and will be correlated with offspring fat mass.
- Conditions
- Obesity, Breast Milk Collection
- Being tested
- Exclusively breastfeed
- Medical subject headings
- Obesity, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusively breastfeedOther
There is no intervention other than mothers must exclusively breastfeed.
| Study group | Role | What they receive |
|---|---|---|
| Mothers-Infant | Mothers who were planning to exclusively breastfeed for six months were enrolled into the study along with their infant. Receives: Other: Exclusively breastfeed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association of breast milk adipocytokines with maternal body mass index at one and 6-months of age.
The associations between breast milk adipocytokines and maternal fatness (i.e. body mass index) will be determined at both one and 6-months.
Measured: One to 6-months.
The association of breast milk adipocytokines with infant body composition at one and 6-months of age.
The associations between breast milk adipocytokines and infant body composition (i.e. total fat and fat-free mass and the percentage of body fat) will be determined at both one and 6-months.
Measured: One to 6-months.
Secondary outcomes (2)
The change in infant body composition (body fat and fat-free mass) from one to 6-months of age.
The change in infant body composition will be measured from 1 to 6-months. Body composition is defined as the change (in grams) in total fat mass, total fat-free mass and the percentage of fat mass (%fat).
Measured: One to 6-months.
The change in breast milk adipocytokines levels from one to 6-months.
The change in leptin (pg/mL), insulin (pg/mL), glucose (mg/mL), ghrelin (pg/mL), IGF-1 (pg/mL), IL-6 (pg/mL), TNFα (pg/mL), high-sensitivity C-reactive protein (pg/mL) will be determined in breast milk from one and 6-months.
Measured: One to 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Principal investigator, David A. Fields, PhD, University of Oklahoma
- Investigators
- David A Fields, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535637
- Sponsor's protocol ID
- 15246
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2015
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolfs D, Lynes MD, Tseng YH, Pierce S, Bussberg V, Darkwah A, Tolstikov V, Narain NR, Rudolph MC, Kiebish MA, Demerath EW, Fields DA, Isganaitis E. Brown Fat-Activating Lipokine 12,13-diHOME in Human Milk Is Associated With Infant Adiposity. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e943-e956. doi: 10.1210/clinem/dgaa799.
PubMed 33135728Isganaitis E, Venditti S, Matthews TJ, Lerin C, Demerath EW, Fields DA. Maternal obesity and the human milk metabolome: associations with infant body composition and postnatal weight gain. Am J Clin Nutr. 2019 Jul 1;110(1):111-120. doi: 10.1093/ajcn/nqy334.
PubMed 30968129Fields DA, George B, Williams M, Whitaker K, Allison DB, Teague A, Demerath EW. Associations between human breast milk hormones and adipocytokines and infant growth and body composition in the first 6 months of life. Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):78-85. doi: 10.1111/ijpo.12182. Epub 2017 Feb 3.
PubMed 28160457Alderete TL, Autran C, Brekke BE, Knight R, Bode L, Goran MI, Fields DA. Associations between human milk oligosaccharides and infant body composition in the first 6 mo of life. Am J Clin Nutr. 2015 Dec;102(6):1381-8. doi: 10.3945/ajcn.115.115451. Epub 2015 Oct 28.
PubMed 26511224
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age
- ClinicalTrials.gov ID
- NCT02535637
- Acronym / sponsor ID
- 15246
- Conditions
- Obesity, Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Aug 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 study is to explore the effect maternal obesity and breastfeeding play on infant body composition. The investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than breast fed infants from normal weight mothers. Furthermore, the investigators postulate that circulating maternal milk adipocytokines will positively correlate to total fat mass at six months of age.
Detailed description
The objective of this study is to determine if offspring from overweight/obese non-diabetic mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at a greater rate from ~ 1 month to 6 months of life compared to breastfed infants from normal weight mothers.
Specific Aim 1: Understand how maternal obesity and breast-feeding impact body composition of the offspring. Based upon the investigators preliminary data and counter to accepted dogma the hypothesis is at six months of age total fat mass, particularly in the trunk will be elevated at 6 months of age in infants whose mother was either overweight or obese vs. infants from normal weight mothers.
Specific Aim 2: Identify adipocytokines in breast milk. The postulate is breast milk from overweight and obese mothers will have greater levels of insulin, glucose, Ghrelin, IGF-1, IL-6, TNFα, high-sensitivity C-reactive protein, and lower Leptin levels than breast milk from normal weight mothers and will be correlated with offspring fat mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers-Infant | – | Other: Exclusively breastfeedMothers who were planning to exclusively breastfeed for six months were enrolled into the study along with their infant. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 37 mothers whom exclusively breast fed to six-months. Participants (mothers/infant) included offspring from mothers with a singleton-term healthy pregnancy (37-40 weeks). Both vaginal and cesarean deliveries were included. Infants who are exclusively breastfed (defined as no formula in the last 20 days) prior to enrollment will be considered.
Key inclusion criteria (8 listed)
- Gestational age between 37 and 41 weeks
- Singleton birth
- Infant in good health
- 40±5 days old at enrollment
- Infant is being exclusively breastfed (defined as fed directly from the breast or with mother's expressed milk and receiving no formula in the last 20 days prior to enrollment)
Key exclusion criteria (5 listed)
- Congenital illness or malformation that affects infant feeding and/or growth
- Significant pre-natal and/or post-natal disease
- Infant has received any complementary feeding, i.e. any nutrition besides breast milk
- In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- Currently participating in another clinical trial
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 |
|---|---|---|
| Exclusively breastfeedThere is no intervention other than mothers must exclusively breastfeed. | Other | Mothers-Infant |
Primary outcome
The association of breast milk adipocytokines with maternal body mass index at one and 6-months of age.
Time frame: One to 6-months.
The associations between breast milk adipocytokines and maternal fatness (i.e. body mass index) will be determined at both one and 6-months.
The association of breast milk adipocytokines with infant body composition at one and 6-months of age.
Time frame: One to 6-months.
The associations between breast milk adipocytokines and infant body composition (i.e. total fat and fat-free mass and the percentage of body fat) will be determined at both one and 6-months.
2 secondary outcomes
The change in infant body composition (body fat and fat-free mass) from one to 6-months of age.
Time frame: One to 6-months.
The change in breast milk adipocytokines levels from one to 6-months.
Time frame: One to 6-months.
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 28 Aug 2015.
- Derived from this study: PubMed 33135728Wolfs D, Lynes MD, Tseng YH, Pierce S, Bussberg V, Darkwah A, Tolstikov V, Narain NR, Rudolph MC, Kiebish MA, Demerath EW, Fields DA, Isganaitis E. Brown Fat-Activating Lipokine 12,13-diHOME in Human Milk Is Associated With Infant Adiposity. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e943-e956. doi: 10.1210/clinem/dgaa799.
- Derived from this study: PubMed 30968129Isganaitis E, Venditti S, Matthews TJ, Lerin C, Demerath EW, Fields DA. Maternal obesity and the human milk metabolome: associations with infant body composition and postnatal weight gain. Am J Clin Nutr. 2019 Jul 1;110(1):111-120. doi: 10.1093/ajcn/nqy334.
- Derived from this study: PubMed 28160457Fields DA, George B, Williams M, Whitaker K, Allison DB, Teague A, Demerath EW. Associations between human breast milk hormones and adipocytokines and infant growth and body composition in the first 6 months of life. Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):78-85. doi: 10.1111/ijpo.12182. Epub 2017 Feb 3.
- Derived from this study: PubMed 26511224Alderete TL, Autran C, Brekke BE, Knight R, Bode L, Goran MI, Fields DA. Associations between human milk oligosaccharides and infant body composition in the first 6 mo of life. Am J Clin Nutr. 2015 Dec;102(6):1381-8. doi: 10.3945/ajcn.115.115451. Epub 2015 Oct 28.
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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.
David A Fields, PhD principal investigator
Faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Breast Milk Collection, run by University of Oklahoma.
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 8 inclusion and 5 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 28 Aug 2015. 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?
The association of breast milk adipocytokines with maternal body mass index at one and 6-months of age. (time frame: One to 6-months.). The study lists 2 primary outcomes in all. 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 NCT02535637, which also lists 4 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 28 Aug 2015.