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- Ensaio Clínico NCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
31 de maio de 2019 atualizado por: Martin Gotteland, University of Chile
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.
Visão geral do estudo
Status
Desconhecido
Tipo de estudo
Observacional
Inscrição (Antecipado)
315
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
315 dyades mother/child recruited at the San Jose Hospital Maternity
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mothers with breastmilk NCSs
Prazo: One month post-partum
|
Proportion of mothers with detectable NCSs in their breastmilk
|
One month post-partum
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mothers with amniotic liquid NCSs
Prazo: At delivery
|
Proportion of mothers with detectable NCSs in their amniotic liquid
|
At delivery
|
|
Consumption of NCSs by the mothers
Prazo: At recruitment (in the last month of pregnancy) and at 1 mont post-partum
|
Daily intake (mg/d) of sucralose, acesulfame-K, cyclamate, saccharin and stevia evaluated through a validated consumer trend survey
|
At recruitment (in the last month of pregnancy) and at 1 mont post-partum
|
|
Pregnancy complications
Prazo: At delivery
|
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
|
At delivery
|
|
Breastmilk concentrations of NCSs
Prazo: One month post-partum
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
|
One month post-partum
|
|
Amniotic liquid concentrations of NCSs
Prazo: At delivery
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
|
At delivery
|
|
Sweet taste of breastmilk
Prazo: One month post-partum
|
Intensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue
|
One month post-partum
|
|
Sweet taste of amniotic liquid
Prazo: At delivery
|
Intensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue
|
At delivery
|
|
Threshold of sweet taste in children
Prazo: 6 months
|
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
|
6 months
|
|
Food preferences in children
Prazo: At 6 month of age
|
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
|
At 6 month of age
|
|
Salivary insulin in children
Prazo: 6 months
|
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
|
6 months
|
|
Infant gain weight
Prazo: At 12 months
|
Changes in weight (kg) during the first year of life
|
At 12 months
|
|
Breast milk microbiota diversity
Prazo: At one month post-partum
|
Intraindividual diversity of the breastmilk microbiota evaluated by Shannon index in samples from quintiles 1 and 5 of classification according to their NCS concentrations
|
At one month post-partum
|
|
Breast milk microbiota composition
Prazo: At one month post-partum
|
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
|
At one month post-partum
|
|
Fecal microbiota diversity in children
Prazo: At six months post-partum
|
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
|
At six months post-partum
|
|
Fecal microbiota composition in children
Prazo: At six months post-partum
|
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
|
At six months post-partum
|
|
Polymorphism of sweet taste receptor in children
Prazo: At six months post-partum
|
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
|
At six months post-partum
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Veronica Sambra, MaSc, University of Chile
- Investigador principal: Sandra Lopez, PhD, University of Chile
- Investigador principal: Paola Caceres, MaSc, University of Chile
- Investigador principal: Francisco Perez, PhD, University of Chile
- Investigador principal: Edgar Pastene, PhD, University of Concepción
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Mennella 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.
- Brown 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.
- 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.
- Sylvetsky 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.
- Duran 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.
- Sylvetsky 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.
- Ruanpeng 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.
- Burke 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.
- Halldorsson 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.
- Rother 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.
- Azad 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.
- Joseph 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.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de julho de 2019
Conclusão Primária (Antecipado)
1 de julho de 2020
Conclusão do estudo (Antecipado)
1 de julho de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
30 de maio de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de maio de 2019
Primeira postagem (Real)
3 de junho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de maio de 2019
Última verificação
1 de maio de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UChile-Fonis SA18I0062
Plano para dados de participantes individuais (IPD)
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