- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
31 maggio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Tipo di studio
Osservativo
Iscrizione (Anticipato)
315
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Martin Gotteland, PhD
- Numero di telefono: 56-229786977
- Email: mgottela@med.uchile.cl
Backup dei contatti dello studio
- Nome: Bielka Carvajal, RM, MaSc
- Numero di telefono: 56-229786611
- Email: bielka.carvajal@gmail.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 40 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
315 dyades mother/child recruited at the San Jose Hospital Maternity
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mothers with breastmilk NCSs
Lasso di tempo: One month post-partum
|
Proportion of mothers with detectable NCSs in their breastmilk
|
One month post-partum
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mothers with amniotic liquid NCSs
Lasso di tempo: At delivery
|
Proportion of mothers with detectable NCSs in their amniotic liquid
|
At delivery
|
Consumption of NCSs by the mothers
Lasso di tempo: 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
Lasso di tempo: At delivery
|
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
|
At delivery
|
Breastmilk concentrations of NCSs
Lasso di tempo: One month post-partum
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
|
One month post-partum
|
Amniotic liquid concentrations of NCSs
Lasso di tempo: At delivery
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
|
At delivery
|
Sweet taste of breastmilk
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At 12 months
|
Changes in weight (kg) during the first year of life
|
At 12 months
|
Breast milk microbiota diversity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At six months post-partum
|
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
|
At six months post-partum
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Veronica Sambra, MaSc, University of Chile
- Investigatore principale: Sandra Lopez, PhD, University of Chile
- Investigatore principale: Paola Caceres, MaSc, University of Chile
- Investigatore principale: Francisco Perez, PhD, University of Chile
- Investigatore principale: Edgar Pastene, PhD, University of Concepción
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 luglio 2019
Completamento primario (Anticipato)
1 luglio 2020
Completamento dello studio (Anticipato)
1 luglio 2021
Date di iscrizione allo studio
Primo inviato
30 maggio 2019
Primo inviato che soddisfa i criteri di controllo qualità
31 maggio 2019
Primo Inserito (Effettivo)
3 giugno 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 maggio 2019
Ultimo verificato
1 maggio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UChile-Fonis SA18I0062
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .