- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03972176
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
31. Mai 2019 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
315
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 40 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
315 dyades mother/child recruited at the San Jose Hospital Maternity
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mothers with breastmilk NCSs
Zeitfenster: One month post-partum
|
Proportion of mothers with detectable NCSs in their breastmilk
|
One month post-partum
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mothers with amniotic liquid NCSs
Zeitfenster: At delivery
|
Proportion of mothers with detectable NCSs in their amniotic liquid
|
At delivery
|
|
Consumption of NCSs by the mothers
Zeitfenster: 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
Zeitfenster: At delivery
|
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
|
At delivery
|
|
Breastmilk concentrations of NCSs
Zeitfenster: One month post-partum
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
|
One month post-partum
|
|
Amniotic liquid concentrations of NCSs
Zeitfenster: At delivery
|
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
|
At delivery
|
|
Sweet taste of breastmilk
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At 12 months
|
Changes in weight (kg) during the first year of life
|
At 12 months
|
|
Breast milk microbiota diversity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At six months post-partum
|
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
|
At six months post-partum
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Veronica Sambra, MaSc, University of Chile
- Hauptermittler: Sandra Lopez, PhD, University of Chile
- Hauptermittler: Paola Caceres, MaSc, University of Chile
- Hauptermittler: Francisco Perez, PhD, University of Chile
- Hauptermittler: Edgar Pastene, PhD, University of Concepción
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. Juli 2019
Primärer Abschluss (Voraussichtlich)
1. Juli 2020
Studienabschluss (Voraussichtlich)
1. Juli 2021
Studienanmeldedaten
Zuerst eingereicht
30. Mai 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Mai 2019
Zuerst gepostet (Tatsächlich)
3. Juni 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. Juni 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. Mai 2019
Zuletzt verifiziert
1. Mai 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UChile-Fonis SA18I0062
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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