Clinical trial NCT03972176: Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: University of Concepcion, Chile
name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2019-06-03
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 315 dyades mother/child recruited at the San Jose Hospital Maternity

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mothers with breastmilk NCSs
timeFrame: One month post-partum
Secondary outcomes:
measure: Mothers with amniotic liquid NCSs
timeFrame: At delivery
measure: Consumption of NCSs by the mothers
timeFrame: At recruitment (in the last month of pregnancy) and at 1 mont post-partum
measure: Pregnancy complications
timeFrame: At delivery
measure: Breastmilk concentrations of NCSs
timeFrame: One month post-partum
measure: Amniotic liquid concentrations of NCSs
timeFrame: At delivery
measure: Sweet taste of breastmilk
timeFrame: One month post-partum
measure: Sweet taste of amniotic liquid
timeFrame: At delivery
measure: Threshold of sweet taste in children
timeFrame: 6 months
measure: Food preferences in children
timeFrame: At 6 month of age
measure: Salivary insulin in children
timeFrame: 6 months
measure: Infant gain weight
timeFrame: At 12 months
measure: Breast milk microbiota diversity
timeFrame: At one month post-partum
measure: Breast milk microbiota composition
timeFrame: At one month post-partum
measure: Fecal microbiota diversity in children
timeFrame: At six months post-partum
measure: Fecal microbiota composition in children
timeFrame: At six months post-partum
measure: Polymorphism of sweet taste receptor in children
timeFrame: At six months post-partum
Other outcomes:
Locations:
Study officials:
affiliation: University of Chile
name: Veronica Sambra, MaSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Sandra Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Paola Caceres, MaSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Francisco Perez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Fabien Magne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Concepción
name: Edgar Pastene, PhD
role: PRINCIPAL_INVESTIGATOR
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