NCT03972176

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 30, 2019

Last Update Submit

May 31, 2019

Conditions

Exposures Associated With Pregnancy, Delivery and Lactation

Keywords

non-caloric sweetenerAmniotic liquidBreastmilkInfant gain weightSweet taste preferencesTaste receptor polymorphismBreastmilk microbiotaInfant gut microbiotaSalivary insulin

Outcome Measures

Primary Outcomes (1)

  • Mothers with breastmilk NCSs

    Proportion of mothers with detectable NCSs in their breastmilk

    One month post-partum

Secondary Outcomes (16)

  • Mothers with amniotic liquid NCSs

    At delivery

  • Consumption of NCSs by the mothers

    At recruitment (in the last month of pregnancy) and at 1 mont post-partum

  • Pregnancy complications

    At delivery

  • Breastmilk concentrations of NCSs

    One month post-partum

  • Amniotic liquid concentrations of NCSs

    At delivery

  • +11 more secondary outcomes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

315 dyades mother/child recruited at the San Jose Hospital Maternity

You may qualify if:

  • Women with at least 36 weeks of gestation
  • Spanish-speaking
  • Elective cesarean delivery

You may not qualify if:

  • Multiple pregnancy
  • Type-2 diabetes
  • Intelectual disability
  • Presence of infectious disease compatible with chorio-amnionitis or immunosupression
  • Newborns with serious pathologies affecting their growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 26654575BACKGROUND

  • 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.

    PMID: 20078374BACKGROUND

  • 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.

    PMID: 28228424BACKGROUND

  • 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.

    PMID: 29511682BACKGROUND

  • 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.

    PMID: 22093863BACKGROUND

  • 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.

    PMID: 28402535BACKGROUND

  • 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.

    PMID: 26048305BACKGROUND

  • 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.

    PMID: 20592133BACKGROUND

  • 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.

    PMID: 26462668BACKGROUND

  • 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.

    PMID: 27159792BACKGROUND

  • 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.

    PMID: 24452237BACKGROUND

  • 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.

    PMID: 26633761BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Veronica Sambra, MaSc

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Sandra Lopez, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Paola Caceres, MaSc

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Francisco Perez, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Fabien Magne, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Edgar Pastene, PhD

    University of Concepción

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Gotteland, PhD

CONTACT

56-229786977mgottela@med.uchile.cl

Bielka Carvajal, RM, MaSc

CONTACT

56-229786611bielka.carvajal@gmail.com

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Lab. of Digestive Physiology

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

June 3, 2019

Record last verified: 2019-05