Exposures Associated With Pregnancy, Delivery and Lactation Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 315 |
| Est. completion date | July 2021 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Chile | Comisión Nacional de Investigación Científica y Tecnológica, University of Concepcion, Chile |
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mothers with breastmilk NCSs | Proportion of mothers with detectable NCSs in their breastmilk | One month post-partum | |
| Secondary | Mothers with amniotic liquid NCSs | Proportion of mothers with detectable NCSs in their amniotic liquid | At delivery | |
| Secondary | Consumption of NCSs by the mothers | 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 | |
| Secondary | Pregnancy complications | Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor | At delivery | |
| Secondary | Breastmilk concentrations of NCSs | Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples | One month post-partum | |
| Secondary | Amniotic liquid concentrations of NCSs | Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples | At delivery | |
| Secondary | Sweet taste of breastmilk | Intensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue | One month post-partum | |
| Secondary | Sweet taste of amniotic liquid | Intensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue | At delivery | |
| Secondary | Threshold of sweet taste in children | 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 | |
| Secondary | Food preferences in children | 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 | |
| Secondary | Salivary insulin in children | 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 | |
| Secondary | Infant gain weight | Changes in weight (kg) during the first year of life | At 12 months | |
| Secondary | Breast milk microbiota diversity | 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 | |
| Secondary | Breast milk microbiota composition | 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 | |
| Secondary | Fecal microbiota diversity in children | 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 | |
| Secondary | Fecal microbiota composition in children | 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 | |
| Secondary | Polymorphism of sweet taste receptor in children | Proportions of children presenting the different polymorphisms on the sweet taste receptor gene. | At six months post-partum |