- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
31. maj 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Undersøgelsestype
Observationel
Tilmelding (Forventet)
315
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Martin Gotteland, PhD
- Telefonnummer: 56-229786977
- E-mail: mgottela@med.uchile.cl
Undersøgelse Kontakt Backup
- Navn: Bielka Carvajal, RM, MaSc
- Telefonnummer: 56-229786611
- E-mail: bielka.carvajal@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
315 dyades mother/child recruited at the San Jose Hospital Maternity
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mothers with breastmilk NCSs
Tidsramme: One month post-partum
|
Proportion of mothers with detectable NCSs in their breastmilk
|
One month post-partum
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mothers with amniotic liquid NCSs
Tidsramme: At delivery
|
Proportion of mothers with detectable NCSs in their amniotic liquid
|
At delivery
|
Consumption of NCSs by the mothers
Tidsramme: 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
Tidsramme: At delivery
|
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
|
At delivery
|
Breastmilk concentrations of NCSs
Tidsramme: One month post-partum
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
|
One month post-partum
|
Amniotic liquid concentrations of NCSs
Tidsramme: At delivery
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
|
At delivery
|
Sweet taste of breastmilk
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At 12 months
|
Changes in weight (kg) during the first year of life
|
At 12 months
|
Breast milk microbiota diversity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At six months post-partum
|
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
|
At six months post-partum
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Veronica Sambra, MaSc, University of Chile
- Ledende efterforsker: Sandra Lopez, PhD, University of Chile
- Ledende efterforsker: Paola Caceres, MaSc, University of Chile
- Ledende efterforsker: Francisco Perez, PhD, University of Chile
- Ledende efterforsker: Edgar Pastene, PhD, University of Concepción
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juli 2019
Primær færdiggørelse (Forventet)
1. juli 2020
Studieafslutning (Forventet)
1. juli 2021
Datoer for studieregistrering
Først indsendt
30. maj 2019
Først indsendt, der opfyldte QC-kriterier
31. maj 2019
Først opslået (Faktiske)
3. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UChile-Fonis SA18I0062
Plan for individuelle deltagerdata (IPD)
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