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

NCT ID: NCT03972176

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-07-31

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.

Conditions

Exposures Associated With Pregnancy, Delivery and Lactation

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Concepcion, Chile

OTHER

Sponsor Role: collaborator

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Martin Gotteland

Head, Lab. of Digestive Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica Sambra, MaSc

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Sandra Lopez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Paola Caceres, MaSc

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Francisco Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Fabien Magne, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Edgar Pastene, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Concepción

Central Contacts

Martin Gotteland, PhD

Role: CONTACT

mgottela@med.uchile.cl

56-229786977

Bielka Carvajal, RM, MaSc

Role: CONTACT

bielka.carvajal@gmail.com

56-229786611

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Other Identifiers

UChile-Fonis SA18I0062

Identifier Type: -

Identifier Source: org_study_id