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Clinical Trials/NCT03972176
NCT03972176
Unknown
Not Applicable

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

University of Chile0 sites315 target enrollmentStarted: July 2019Last updated:

Overview

Phase
Not Applicable
Sponsor
University of Chile
Enrollment
315
Primary Endpoint
Mothers with breastmilk NCSs

Overview

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.

Study Design

Study Type
Observational
Observational Model
Family Based
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Mothers with breastmilk NCSs

Time Frame: One month post-partum

Proportion of mothers with detectable NCSs in their breastmilk

Secondary Outcomes

  • Mothers with amniotic liquid NCSs(At delivery)
  • Breastmilk concentrations of NCSs(One month post-partum)
  • Salivary insulin in children(6 months)
  • Sweet taste of amniotic liquid(At delivery)
  • Food preferences in children(At 6 month of age)
  • Infant gain weight(At 12 months)
  • Pregnancy complications(At delivery)
  • Breast milk microbiota diversity(At one month post-partum)
  • Breast milk microbiota composition(At one month post-partum)
  • Consumption of NCSs by the mothers(At recruitment (in the last month of pregnancy) and at 1 mont post-partum)
  • Amniotic liquid concentrations of NCSs(At delivery)
  • Polymorphism of sweet taste receptor in children(At six months post-partum)
  • Threshold of sweet taste in children(6 months)
  • Sweet taste of breastmilk(One month post-partum)
  • Fecal microbiota composition in children(At six months post-partum)
  • Fecal microbiota diversity in children(At six months post-partum)

Investigators

Sponsor
University of Chile
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Gotteland

Head, Lab. of Digestive Physiology

University of Chile

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