- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
31 de mayo de 2019 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Tipo de estudio
De observación
Inscripción (Anticipado)
315
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
315 dyades mother/child recruited at the San Jose Hospital Maternity
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mothers with breastmilk NCSs
Periodo de tiempo: One month post-partum
|
Proportion of mothers with detectable NCSs in their breastmilk
|
One month post-partum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mothers with amniotic liquid NCSs
Periodo de tiempo: At delivery
|
Proportion of mothers with detectable NCSs in their amniotic liquid
|
At delivery
|
|
Consumption of NCSs by the mothers
Periodo de tiempo: 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
Periodo de tiempo: At delivery
|
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
|
At delivery
|
|
Breastmilk concentrations of NCSs
Periodo de tiempo: One month post-partum
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
|
One month post-partum
|
|
Amniotic liquid concentrations of NCSs
Periodo de tiempo: At delivery
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
|
At delivery
|
|
Sweet taste of breastmilk
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At 12 months
|
Changes in weight (kg) during the first year of life
|
At 12 months
|
|
Breast milk microbiota diversity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2019
Finalización primaria (Anticipado)
1 de julio de 2020
Finalización del estudio (Anticipado)
1 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2019
Publicado por primera vez (Actual)
3 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UChile-Fonis SA18I0062
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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