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Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03972176
Enrollment
315
Registered
2019-06-03
Start date
2019-07-31
Completion date
2021-07-31
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposures Associated With Pregnancy, Delivery and Lactation

Keywords

non-caloric sweetener, Amniotic liquid, Breastmilk, Infant gain weight, Sweet taste preferences, Taste receptor polymorphism, Breastmilk microbiota, Infant gut microbiota, Salivary insulin

Brief 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. 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.

Interventions

None listed

Sponsors

University of Concepcion, Chile
CollaboratorOTHER
Comisión Nacional de Investigación Científica y Tecnológica
CollaboratorOTHER_GOV
University of Chile
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Women with at least 36 weeks of gestation * Spanish-speaking * Elective cesarean delivery

Exclusion criteria

* Multiple pregnancy * Type-2 diabetes * Intelectual disability * Presence of infectious disease compatible with chorio-amnionitis or immunosupression * Newborns with serious pathologies affecting their growth

Design outcomes

Primary

MeasureTime frameDescription
Mothers with breastmilk NCSsOne month post-partumProportion of mothers with detectable NCSs in their breastmilk

Secondary

MeasureTime frameDescription
Consumption of NCSs by the mothersAt recruitment (in the last month of pregnancy) and at 1 mont post-partumDaily intake (mg/d) of sucralose, acesulfame-K, cyclamate, saccharin and stevia evaluated through a validated consumer trend survey
Pregnancy complicationsAt deliveryPercentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
Breastmilk concentrations of NCSsOne month post-partumConcentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
Amniotic liquid concentrations of NCSsAt deliveryConcentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
Sweet taste of breastmilkOne month post-partumIntensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue
Sweet taste of amniotic liquidAt deliveryIntensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue
Threshold of sweet taste in children6 monthsDetermination 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
Mothers with amniotic liquid NCSsAt deliveryProportion of mothers with detectable NCSs in their amniotic liquid
Salivary insulin in children6 monthsSalivary 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
Infant gain weightAt 12 monthsChanges in weight (kg) during the first year of life
Breast milk microbiota diversityAt one month post-partumIntraindividual diversity of the breastmilk microbiota evaluated by Shannon index in samples from quintiles 1 and 5 of classification according to their NCS concentrations
Breast milk microbiota compositionAt one month post-partumRelative 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
Fecal microbiota diversity in childrenAt six months post-partumIntraindividual 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
Fecal microbiota composition in childrenAt six months post-partumRelative 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
Polymorphism of sweet taste receptor in childrenAt six months post-partumProportions of children presenting the different polymorphisms on the sweet taste receptor gene.
Food preferences in childrenAt 6 month of ageFood 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

Contacts

Primary ContactMartin Gotteland, PhD
mgottela@med.uchile.cl56-229786977
Backup ContactBielka Carvajal, RM, MaSc
bielka.carvajal@gmail.com56-229786611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026