LactationNCT02940795
Dietary Sugars Found In Breast Milk
A study testing Coke and Diet Rite in people with Lactation, run by University of Oklahoma.
Trial summary
The majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity and neonatal insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Coke and Diet Rite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2016
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exclusively lactating mothers
- Mothers must be 3 weeks to 6 weeks postpartum
Who cannot join
- Smoked during pregnancy or are currently smoking
- Unable to provide breast milk samples using a breast pump
About this study
Official title: Maternal Transmission of Dietary Sugars in Breast Milk
The majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity and neonatal insulin resistance.
Conventional wisdom holds that breast-milk composition is uniform; recently our group has questioned this. An increase in consumption of dietary sugars including fructose over the past 30 years has risen, and this has been associated with chronic metabolic and endocrine disorders and phenotypic alterations that promote obesity and diabetes. However, no prior studies have examined how maternal increases of sugars/fructose during lactation affects breast-milk composition with potential transmission to the infant. The objective of this proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including fructose in human breast-milk in response to maternal consumption. The central hypothesis is that a graded, dose-response relationship be-tween maternal adiposity and sugar concentrations in breast-milk exist and that milk fructose concentrations are associated with altered body composition in the first months of life. This proposal, guided by compelling preliminary data will examine the evidence linking high intakes of milk fructose with altered metabolism and early obesity by pursuing two Specific Aims: 1) Test novel relationships between breast-milk sugars and changes in infant fat mass and 2) Characterize the pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are significant given the intractability of obesity/diabetes and a potentially identifiable novel target, making for a clear but powerful public message to reduce sugary beverage consumption during lactation.
Read the detailed description
One of the most highly effective preventive measures a mother can make in protecting the health of her infant and herself is to breastfeed. Despite extensive research on breast-milk, limited information beyond basic micro/macronutrient composition currently exists in the literature. Breast-milk is a complex, non-uniform biological substance. In prior studies the PI has shown significant associations be-tween non-nutritive constituents in breast-milk (e.g. IL-6, TNF-α, insulin, leptin) and body composition in infants starting at 4wks of age. The putative causal influence of breastfeeding reducing obesity is mixed with no clear probative evidence showing causal pathways. Despite many studies in this area, there are no detailed studies that have examined the potential modifying role of maternal diet, especially one high in sugars on the compositional makeup of the three largest breast-milk sugars (glucose, galactose and lactose) with none to date looking at fructose. Animal models have demonstrated that the obesogenic effect of maternal fructose consumption is transmitted to offspring via breast-milk with fructose-fed lactating dams producing offspring with double fasting insulin levels compared to control pups. This is relevant in humans because of the increase in dietary sugar consumption that has occurred in the population.
A mother/infant cohort (n=37) has been established with detailed infant phenotypic body composition (dual-energy X-ray absorptiometry) and detailed breast-milk analysis (insulin, leptin, IL-6, TNF-α but no milk sugars other than glucose) in exclusively breast feeding mothers varying widely in BMI (19 to 44 kg/m2). Sampling of breast-milk and infant body composition occurred at both 4 and 24wks. As a proof of concept, fructose was detected in breast-milk from 9 of these mothers which was significantly related to infant body fat, which is a novel finding to date and has never been reported in the literature. Building upon this prior work this study will determine the concentration and pharmacokinetics of breast-milk sugars after a test beverage is consumed.
- Conditions
- Lactation
- Being tested
- Coke, Diet Rite
- Keywords
- breast feeding, fructose
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CokeOther
Patients were given a 20 ounce bottle of Coke Cola.
Diet RiteOther
Patients were given a 12 ounce can of Diet Rite.
| Study group | Role | What they receive |
|---|---|---|
| Coke cola | Experimental | Exclusively lactating mothers with infants between 4-6 weeks were investigated. Lactating mothers will be consume a 20 ounce bottle of coke cola. Receives: Other: Coke; Other: Diet Rite |
| Diet Rite | Experimental | Exclusively lactating mothers with infants between 4-6 weeks were asked to consume a 12 ounce bottle of diet rite. Receives: Other: Coke; Other: Diet Rite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fructose in breast milk will be measured in human breast milk at one month.
Breast milk fructose at one month will be analyzed.
Measured: One month
The change in fructose in breast milk from one to six months.
The potential change in breast milk fructose from one to six months will be investigated.
Measured: Six months
Secondary outcomes (1)
Breast milk fructose will be measured after the ingestion of a regular 20 ounce bottle of coke and a 12 ounce can of diet rite.
After the ingestion of either a regular 20 ounce bottle of coke or a 12 ounce can of diet rite at ~ 6:00 am a milk sample will be obtained every hour until 12:00 pm.
Measured: 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LactationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Fields, PhD, University of Oklahoma
- Investigators
- David A Fields, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940795
- Sponsor's protocol ID
- 5297
- Status last verified
- Jan 2017
- First submitted
- 14 Oct 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No there is not a plan to share data.
Publications
Rother KI, Sylvetsky AC, Walter PJ, Garraffo HM, Fields DA. Pharmacokinetics of Sucralose and Acesulfame-Potassium in Breast Milk Following Ingestion of Diet Soda. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):466-470. doi: 10.1097/MPG.0000000000001817.
PubMed 29077645
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Transmission of Dietary Sugars in Breast Milk
- ClinicalTrials.gov ID
- NCT02940795
- Acronym / sponsor ID
- 5297
- Conditions
- Lactation
- Keywords
- breast feeding, fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2016 (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 majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity and neonatal insulin resistance.
Conventional wisdom holds that breast-milk composition is uniform; recently our group has questioned this. An increase in consumption of dietary sugars including fructose over the past 30 years has risen, and this has been associated with chronic metabolic and endocrine disorders and phenotypic alterations that promote obesity and diabetes. However, no prior studies have examined how maternal increases of sugars/fructose during lactation affects breast-milk composition with potential transmission to the infant. The objective of this proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including fructose in human breast-milk in response to maternal consumption. The central hypothesis is that a graded, dose-response relationship be-tween maternal adiposity and sugar concentrations in breast-milk exist and that milk fructose concentrations are associated with altered body composition in the first months of life. This proposal, guided by compelling preliminary data will examine the evidence linking high intakes of milk fructose with altered metabolism and early obesity by pursuing two Specific Aims: 1) Test novel relationships between breast-milk sugars and changes in infant fat mass and 2) Characterize the pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are significant given the intractability of obesity/diabetes and a potentially identifiable novel target, making for a clear but powerful public message to reduce sugary beverage consumption during lactation.
Detailed description
One of the most highly effective preventive measures a mother can make in protecting the health of her infant and herself is to breastfeed. Despite extensive research on breast-milk, limited information beyond basic micro/macronutrient composition currently exists in the literature. Breast-milk is a complex, non-uniform biological substance. In prior studies the PI has shown significant associations be-tween non-nutritive constituents in breast-milk (e.g. IL-6, TNF-α, insulin, leptin) and body composition in infants starting at 4wks of age. The putative causal influence of breastfeeding reducing obesity is mixed with no clear probative evidence showing causal pathways. Despite many studies in this area, there are no detailed studies that have examined the potential modifying role of maternal diet, especially one high in sugars on the compositional makeup of the three largest breast-milk sugars (glucose, galactose and lactose) with none to date looking at fructose. Animal models have demonstrated that the obesogenic effect of maternal fructose consumption is transmitted to offspring via breast-milk with fructose-fed lactating dams producing offspring with double fasting insulin levels compared to control pups. This is relevant in humans because of the increase in dietary sugar consumption that has occurred in the population.
A mother/infant cohort (n=37) has been established with detailed infant phenotypic body composition (dual-energy X-ray absorptiometry) and detailed breast-milk analysis (insulin, leptin, IL-6, TNF-α but no milk sugars other than glucose) in exclusively breast feeding mothers varying widely in BMI (19 to 44 kg/m2). Sampling of breast-milk and infant body composition occurred at both 4 and 24wks. As a proof of concept, fructose was detected in breast-milk from 9 of these mothers which was significantly related to infant body fat, which is a novel finding to date and has never been reported in the literature. Building upon this prior work this study will determine the concentration and pharmacokinetics of breast-milk sugars after a test beverage is consumed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coke cola | Experimental | Other: Coke, Other: Diet RiteExclusively lactating mothers with infants between 4-6 weeks were investigated. Lactating mothers will be consume a 20 ounce bottle of coke cola. |
| Diet Rite | Experimental | Other: Coke, Other: Diet RiteExclusively lactating mothers with infants between 4-6 weeks were asked to consume a 12 ounce bottle of diet rite. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exclusively lactating mothers
- Mothers must be 3 weeks to 6 weeks postpartum
Key exclusion criteria (2 listed)
- Smoked during pregnancy or are currently smoking
- Unable to provide breast milk samples using a breast pump
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 |
|---|---|---|
| CokePatients were given a 20 ounce bottle of Coke Cola. | Other | Coke cola, Diet Rite |
| Diet RitePatients were given a 12 ounce can of Diet Rite. | Other | Coke cola, Diet Rite |
Primary outcome
Fructose in breast milk will be measured in human breast milk at one month.
Time frame: One month
Breast milk fructose at one month will be analyzed.
The change in fructose in breast milk from one to six months.
Time frame: Six months
The potential change in breast milk fructose from one to six months will be investigated.
1 secondary outcome
Breast milk fructose will be measured after the ingestion of a regular 20 ounce bottle of coke and a 12 ounce can of diet rite.
Time frame: 6 hours.
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 24 Jan 2017.
- Derived from this study: PubMed 29077645Rother KI, Sylvetsky AC, Walter PJ, Garraffo HM, Fields DA. Pharmacokinetics of Sucralose and Acesulfame-Potassium in Breast Milk Following Ingestion of Diet Soda. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):466-470. doi: 10.1097/MPG.0000000000001817.
- Individual participant dataSharing planned: No. No there is not a plan to share data.
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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
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
A study testing Coke and Diet Rite in people with Lactation, 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 2 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 24 Jan 2017. 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?
Fructose in breast milk will be measured in human breast milk at one month. (time frame: One month). 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 NCT02940795, which also lists 1 linked publication.
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 24 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.