Exposures Associated With Pregnancy, Delivery and LactationNCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
An observational study of Exposures Associated With Pregnancy, Delivery and Lactation, run by University of Chile.
Trial summary
During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile. This situation has reached a point where it is currently difficult to find sugary foods without NCSs. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposures Associated With Pregnancy, Delivery and Lactation
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Jul 2021
- How long will I take part?
- 12 Months
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 315 dyades mother/child recruited at the San Jose Hospital Maternity
Who may be able to join
- Women with at least 36 weeks of gestation
- Spanish-speaking
- Elective cesarean delivery
Who cannot join
- Multiple pregnancy
- Type-2 diabetes
- Intelectual disability
- Presence of infectious disease compatible with chorio-amnionitis or immunosupression
- Newborns with serious pathologies affecting their growth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determination of Perinatal Exposure to Non-caloric Sweeteners. Implications for the Development of Preferences for Sweet Taste, and Weight Gain During the First Year of Life
During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile. This situation has reached a point where it is currently difficult to find sugary foods without NCSs. As a result, the voluntary and involuntary consumption of these additives is growing significantly in the population, increasing the risk of exceeding the acceptable daily intake (ADI), especially for children. This situation is worrying as recent evidence suggests that NCSs are not inert in the body and can trigger adverse metabolic effects. For example, the consumption of beverages with NCSs has been shown to favor the development of obesity and type-2 diabetes in children and adults, and a recent study reported that the intake of NCSs during pregnancy was associated with a greater weight gain of the child at one year. It is likely that certain NCSs pass into the amniotic fluid and that the fetus is exposed to some of these compounds during pregnancy. This situation would persist in the infant through breast milk, as some studies detected sucralose and acesulfame-K in this fluid, even in mothers who claimed not to consume them. However, the real impact of NCS exposure during the neonatal period on the child health has been few studied. Therefore, the aim of this study is to determine the concentration of NCSs in samples of amniotic liquid and breastmilk and to correlate these data with the NCS intake by the mothers. Mothers/children will be classified in quintiles according to the results obtained. In the children from quintiles 1 and 5, we will also study whether neonatal exposure to NCSs may affect the sweet taste threshold and the preferences for this taste, the levels of salivary insulin and the weight gain in the first year. Breastmilk microbiota and child fecal microbiota will be also evaluated.
- Keywords
- non-caloric sweetener, Amniotic liquid, Breastmilk, Infant gain weight, Sweet taste preferences, Taste receptor polymorphism, Breastmilk microbiota, Infant gut microbiota, Salivary insulin
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers with breastmilk NCSs
Proportion of mothers with detectable NCSs in their breastmilk
Measured: One month post-partum
Secondary outcomes (16)
Mothers with amniotic liquid NCSs
Proportion of mothers with detectable NCSs in their amniotic liquid
Measured: At delivery
Consumption of NCSs by the mothers
Daily intake (mg/d) of sucralose, acesulfame-K, cyclamate, saccharin and stevia evaluated through a validated consumer trend survey
Measured: At recruitment (in the last month of pregnancy) and at 1 mont post-partum
Pregnancy complications
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
Measured: At delivery
Breastmilk concentrations of NCSs
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
Measured: One month post-partum
Amniotic liquid concentrations of NCSs
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
Measured: At delivery
Sweet taste of breastmilk
Intensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue
Measured: One month post-partum
Sweet taste of amniotic liquid
Intensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue
Measured: At delivery
Threshold of sweet taste in children
Determination of sweet taste threshold (lower concentration of sucrose detected) in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that received
Measured: 6 months
Food preferences in children
Food consumption in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that receiveded,through a validated consumer trend survey
Measured: At 6 month of age
Salivary insulin in children
Salivary concentration of insulin (pg/ml) in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
Measured: 6 months
Infant gain weight
Changes in weight (kg) during the first year of life
Measured: At 12 months
Breast milk microbiota diversity
Intraindividual diversity of the breastmilk microbiota evaluated by Shannon index in samples from quintiles 1 and 5 of classification according to their NCS concentrations
Measured: At one month post-partum
Breast milk microbiota composition
Relative abundancies of the different bacterial taxa from the breastmilk microbiota, detected by high throughput sequencing, in samples from quintiles 1 and 5 of classification according to their NCS concentrations
Measured: At one month post-partum
Fecal microbiota diversity in children
Intraindividual diversity of the fecal microbiota, evaluated by Shannon index, in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
Measured: At six months post-partum
Fecal microbiota composition in children
Relative abundancies of the different bacterial taxa from the fecal microbiota, detected by high throughput sequencing, in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
Measured: At six months post-partum
Polymorphism of sweet taste receptor in children
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
Measured: At six months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Exposures Associated With Pregnancy, Delivery and 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Concepcion, Chile, Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Martin Gotteland, University of Chile
- Investigators
- Veronica Sambra, MaSc, Principal investigator, University of ChileSandra Lopez, PhD, Principal investigator, University of ChilePaola Caceres, MaSc, Principal investigator, University of ChileFrancisco Perez, PhD, Principal investigator, University of ChileFabien Magne, PhD, Principal investigator, University of ChileEdgar Pastene, PhD, Principal investigator, University of Concepción
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972176
- Sponsor's protocol ID
- UChile-Fonis SA18I0062
- Status last verified
- May 2019
- First submitted
- 30 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Popkin BM, Hawkes C. Sweetening of the global diet, particularly beverages: patterns, trends, and policy responses. Lancet Diabetes Endocrinol. 2016 Feb;4(2):174-86. doi: 10.1016/S2213-8587(15)00419-2. Epub 2015 Dec 2.
PubMed 26654575Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
PubMed 20078374Sylvetsky AC, Walter PJ, Garraffo HM, Robien K, Rother KI. Widespread sucralose exposure in a randomized clinical trial in healthy young adults. Am J Clin Nutr. 2017 Apr;105(4):820-823. doi: 10.3945/ajcn.116.144402. Epub 2017 Feb 22.
PubMed 28228424Duran Aguero S, Angarita Davila L, Escobar Contreras MC, Rojas Gomez D, de Assis Costa J. Noncaloric Sweeteners in Children: A Controversial Theme. Biomed Res Int. 2018 Jan 8;2018:4806534. doi: 10.1155/2018/4806534. eCollection 2018.
PubMed 29511682Sylvetsky A, Rother KI, Brown R. Artificial sweetener use among children: epidemiology, recommendations, metabolic outcomes, and future directions. Pediatr Clin North Am. 2011 Dec;58(6):1467-80, xi. doi: 10.1016/j.pcl.2011.09.007. Epub 2011 Oct 14.
PubMed 22093863Ruanpeng D, Thongprayoon C, Cheungpasitporn W, Harindhanavudhi T. Sugar and artificially sweetened beverages linked to obesity: a systematic review and meta-analysis. QJM. 2017 Aug 1;110(8):513-520. doi: 10.1093/qjmed/hcx068.
PubMed 28402535Burke MV, Small DM. Physiological mechanisms by which non-nutritive sweeteners may impact body weight and metabolism. Physiol Behav. 2015 Dec 1;152(Pt B):381-8. doi: 10.1016/j.physbeh.2015.05.036. Epub 2015 Jun 3.
PubMed 26048305Halldorsson TI, Strom M, Petersen SB, Olsen SF. Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women. Am J Clin Nutr. 2010 Sep;92(3):626-33. doi: 10.3945/ajcn.2009.28968. Epub 2010 Jun 30.
PubMed 20592133Rother KI, Sylvetsky AC, Schiffman SS. Non-nutritive sweeteners in breast milk: perspective on potential implications of recent findings. Arch Toxicol. 2015 Nov;89(11):2169-71. doi: 10.1007/s00204-015-1611-9. Epub 2015 Oct 14. No abstract available.
PubMed 26462668Azad MB, Sharma AK, de Souza RJ, Dolinsky VW, Becker AB, Mandhane PJ, Turvey SE, Subbarao P, Lefebvre DL, Sears MR; Canadian Healthy Infant Longitudinal Development Study Investigators. Association Between Artificially Sweetened Beverage Consumption During Pregnancy and Infant Body Mass Index. JAMA Pediatr. 2016 Jul 1;170(7):662-70. doi: 10.1001/jamapediatrics.2016.0301.
PubMed 27159792Mennella JA. Ontogeny of taste preferences: basic biology and implications for health. Am J Clin Nutr. 2014 Mar;99(3):704S-11S. doi: 10.3945/ajcn.113.067694. Epub 2014 Jan 22.
PubMed 24452237Joseph PV, Reed DR, Mennella JA. Individual Differences Among Children in Sucrose Detection Thresholds: Relationship With Age, Gender, and Bitter Taste Genotype. Nurs Res. 2016 Jan-Feb;65(1):3-12. doi: 10.1097/NNR.0000000000000138.
PubMed 26633761
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Perinatal Exposure to Non-caloric Sweeteners. Implications for the Development of Preferences for Sweet Taste, and Weight Gain During the First Year of Life
- ClinicalTrials.gov ID
- NCT03972176
- Acronym / sponsor ID
- UChile-Fonis SA18I0062
- Keywords
- non-caloric sweetener, Amniotic liquid, Breastmilk, Infant gain weight, Sweet taste preferences, Taste receptor polymorphism, Breastmilk microbiota, Infant gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- University of Concepcion, Chile, Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- 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.
During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile. This situation has reached a point where it is currently difficult to find sugary foods without NCSs. As a result, the voluntary and involuntary consumption of these additives is growing significantly in the population, increasing the risk of exceeding the acceptable daily intake (ADI), especially for children. This situation is worrying as recent evidence suggests that NCSs are not inert in the body and can trigger adverse metabolic effects. For example, the consumption of beverages with NCSs has been shown to favor the development of obesity and type-2 diabetes in children and adults, and a recent study reported that the intake of NCSs during pregnancy was associated with a greater weight gain of the child at one year. It is likely that certain NCSs pass into the amniotic fluid and that the fetus is exposed to some of these compounds during pregnancy. This situation would persist in the infant through breast milk, as some studies detected sucralose and acesulfame-K in this fluid, even in mothers who claimed not to consume them. However, the real impact of NCS exposure during the neonatal period on the child health has been few studied. Therefore, the aim of this study is to determine the concentration of NCSs in samples of amniotic liquid and breastmilk and to correlate these data with the NCS intake by the mothers. Mothers/children will be classified in quintiles according to the results obtained. In the children from quintiles 1 and 5, we will also study whether neonatal exposure to NCSs may affect the sweet taste threshold and the preferences for this taste, the levels of salivary insulin and the weight gain in the first year. Breastmilk microbiota and child fecal microbiota will be also evaluated.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 315 dyades mother/child recruited at the San Jose Hospital Maternity
Key inclusion criteria (3 listed)
- Women with at least 36 weeks of gestation
- Spanish-speaking
- Elective cesarean delivery
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Type-2 diabetes
- Intelectual disability
- Presence of infectious disease compatible with chorio-amnionitis or immunosupression
- Newborns with serious pathologies affecting their growth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mothers with breastmilk NCSs
Time frame: One month post-partum
Proportion of mothers with detectable NCSs in their breastmilk
16 secondary outcomes
Mothers with amniotic liquid NCSs
Time frame: At delivery
Consumption of NCSs by the mothers
Time frame: At recruitment (in the last month of pregnancy) and at 1 mont post-partum
Pregnancy complications
Time frame: At delivery
Breastmilk concentrations of NCSs
Time frame: One month post-partum
Amniotic liquid concentrations of NCSs
Time frame: At delivery
Sweet taste of breastmilk
Time frame: One month post-partum
Sweet taste of amniotic liquid
Time frame: At delivery
Threshold of sweet taste in children
Time frame: 6 months
Food preferences in children
Time frame: At 6 month of age
Salivary insulin in children
Time frame: 6 months
Infant gain weight
Time frame: At 12 months
Breast milk microbiota diversity
Time frame: At one month post-partum
Breast milk microbiota composition
Time frame: At one month post-partum
Fecal microbiota diversity in children
Time frame: At six months post-partum
Fecal microbiota composition in children
Time frame: At six months post-partum
Polymorphism of sweet taste receptor in children
Time frame: At six months post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Background: PubMed 26654575Popkin BM, Hawkes C. Sweetening of the global diet, particularly beverages: patterns, trends, and policy responses. Lancet Diabetes Endocrinol. 2016 Feb;4(2):174-86. doi: 10.1016/S2213-8587(15)00419-2. Epub 2015 Dec 2.
- Background: PubMed 20078374Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
- Background: PubMed 28228424Sylvetsky AC, Walter PJ, Garraffo HM, Robien K, Rother KI. Widespread sucralose exposure in a randomized clinical trial in healthy young adults. Am J Clin Nutr. 2017 Apr;105(4):820-823. doi: 10.3945/ajcn.116.144402. Epub 2017 Feb 22.
- Background: PubMed 29511682Duran Aguero S, Angarita Davila L, Escobar Contreras MC, Rojas Gomez D, de Assis Costa J. Noncaloric Sweeteners in Children: A Controversial Theme. Biomed Res Int. 2018 Jan 8;2018:4806534. doi: 10.1155/2018/4806534. eCollection 2018.
- Background: PubMed 22093863Sylvetsky A, Rother KI, Brown R. Artificial sweetener use among children: epidemiology, recommendations, metabolic outcomes, and future directions. Pediatr Clin North Am. 2011 Dec;58(6):1467-80, xi. doi: 10.1016/j.pcl.2011.09.007. Epub 2011 Oct 14.
- Background: PubMed 28402535Ruanpeng D, Thongprayoon C, Cheungpasitporn W, Harindhanavudhi T. Sugar and artificially sweetened beverages linked to obesity: a systematic review and meta-analysis. QJM. 2017 Aug 1;110(8):513-520. doi: 10.1093/qjmed/hcx068.
- Background: PubMed 26048305Burke MV, Small DM. Physiological mechanisms by which non-nutritive sweeteners may impact body weight and metabolism. Physiol Behav. 2015 Dec 1;152(Pt B):381-8. doi: 10.1016/j.physbeh.2015.05.036. Epub 2015 Jun 3.
- Background: PubMed 20592133Halldorsson TI, Strom M, Petersen SB, Olsen SF. Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women. Am J Clin Nutr. 2010 Sep;92(3):626-33. doi: 10.3945/ajcn.2009.28968. Epub 2010 Jun 30.
- Background: PubMed 26462668Rother KI, Sylvetsky AC, Schiffman SS. Non-nutritive sweeteners in breast milk: perspective on potential implications of recent findings. Arch Toxicol. 2015 Nov;89(11):2169-71. doi: 10.1007/s00204-015-1611-9. Epub 2015 Oct 14. No abstract available.
- Background: PubMed 27159792Azad MB, Sharma AK, de Souza RJ, Dolinsky VW, Becker AB, Mandhane PJ, Turvey SE, Subbarao P, Lefebvre DL, Sears MR; Canadian Healthy Infant Longitudinal Development Study Investigators. Association Between Artificially Sweetened Beverage Consumption During Pregnancy and Infant Body Mass Index. JAMA Pediatr. 2016 Jul 1;170(7):662-70. doi: 10.1001/jamapediatrics.2016.0301.
- Background: PubMed 24452237Mennella JA. Ontogeny of taste preferences: basic biology and implications for health. Am J Clin Nutr. 2014 Mar;99(3):704S-11S. doi: 10.3945/ajcn.113.067694. Epub 2014 Jan 22.
- Background: PubMed 26633761Joseph PV, Reed DR, Mennella JA. Individual Differences Among Children in Sucrose Detection Thresholds: Relationship With Age, Gender, and Bitter Taste Genotype. Nurs Res. 2016 Jan-Feb;65(1):3-12. doi: 10.1097/NNR.0000000000000138.
- New food labelling law in ChileLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Veronica Sambra, MaSc principal investigator
University of Chile
Sandra Lopez, PhD principal investigator
University of Chile
Paola Caceres, MaSc principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
An observational study of Exposures Associated With Pregnancy, Delivery and Lactation, run by University of Chile.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Gotteland, PhD (56-229786977, mgottela@med.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mothers with breastmilk NCSs (time frame: One month post-partum). 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 NCT03972176, which also lists 12 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 3 Jun 2019.