Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
- Conditions
- Exposures Associated With Pregnancy, Delivery and Lactation
- Registration Number
- NCT03972176
- Lead Sponsor
- University of Chile
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 315
- Women with at least 36 weeks of gestation
- Spanish-speaking
- Elective cesarean delivery
- Multiple pregnancy
- Type-2 diabetes
- Intelectual disability
- Presence of infectious disease compatible with chorio-amnionitis or immunosupression
- Newborns with serious pathologies affecting their growth
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mothers with breastmilk NCSs One month post-partum Proportion of mothers with detectable NCSs in their breastmilk
- Secondary Outcome Measures
Name Time Method Mothers with amniotic liquid NCSs At delivery Proportion of mothers with detectable NCSs in their amniotic liquid
Breastmilk concentrations of NCSs One month post-partum Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
Salivary insulin in children 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
Sweet taste of amniotic liquid At delivery Intensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue
Food preferences in children 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
Infant gain weight At 12 months Changes in weight (kg) during the first year of life
Pregnancy complications At delivery Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
Consumption of NCSs by the mothers 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
Amniotic liquid concentrations of NCSs At delivery Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
Breast milk microbiota diversity 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
Breast milk microbiota composition 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
Polymorphism of sweet taste receptor in children At six months post-partum Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
Sweet taste of breastmilk One month post-partum Intensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue
Threshold of sweet taste in children 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
Fecal microbiota composition in children 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
Fecal microbiota diversity in children 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