Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.

Study Overview
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Brief Summary
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This study evaluates the presence and quantity of non-caloric sweeteners in newborns umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months and 6 months of age. Microbiota composition will be evaluated in milk and in feces of both mother and child.

Detailed Description
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The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as diet. Despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent ENC users are also at risk of excessive weight gain, type II diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the early stages of life may predispose to the development of metabolic disorders later in life.The ENC have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of ENC consumption has not been investigated. This makes it relevant to study the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption of ENC.

Official Title
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Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.

Conditions
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Microbial Colonization

Intervention / Treatment
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* Other: No intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-40 years old Women in labor Consent to participate in the study Exclusion Criteria: Pre-term delivery (<30 weeks) Metabolic diseases (insulin resistance, diabetes, gestational diabetes) Hypertension Thyroid disease Cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Null or low consumption<br>No-intervention. The group consists of women who have reported a null or low consumption of non-caloric sweeteners during late pregnancy. | Other: No intervention.<br>* No intervention<br>|
| Moderate consumption<br>No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy. | Other: No intervention.<br>* No intervention<br>|
| High consumption<br>No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy. | Other: No intervention.<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota composition in feces | Composition of feces microbiota in mother and newborn | 2 months | 
| Microbiota composition in feces | Composition of feces microbiota in mother and newborn | 4 months | 
| Microbiota composition in feces | Composition of feces microbiota in mother and newborn | 6 months | 
| Microbiota composition in breast milk | Composition of breast milk microbiota | 0 months | 
| Microbiota composition in breast milk | Composition of breast milk microbiota | 2 months | 
| Microbiota composition in breast milk | Composition of breast milk microbiota | 4 months | 
| Microbiota composition in breast milk | Composition of breast milk microbiota | 6 months | 
| Non-caloric sweeteners levels at birth | Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL | at birth | 
| Non-caloric sweeteners levels 2 months follow-up | Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up | 2 months after birth | 
| Non-caloric sweeteners levels 4 months follow-up | Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up | 4 months after birth | 
| Non-caloric sweeteners levels 6 months follow-up | Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up | 6 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-caloric sweeteners, microbiota, breast milk, umbilical cord