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

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ClinicalTrials.gov Identifier: NCT03912038
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Marcela Esquivel V, Hospital General de México Dr. Eduardo Liceaga

Brief Summary:
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.

Condition or disease Intervention/treatment
Microbial Colonization Other: No intervention.

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 544 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Null or low consumption
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.
No intervention

Moderate consumption
No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy.
Other: No intervention.
No intervention

High consumption
No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy.
Other: No intervention.
No intervention




Primary Outcome Measures :
  1. Microbiota composition in feces [ Time Frame: 2 months ]
    Composition of feces microbiota in mother and newborn

  2. Microbiota composition in feces [ Time Frame: 4 months ]
    Composition of feces microbiota in mother and newborn

  3. Microbiota composition in feces [ Time Frame: 6 months ]
    Composition of feces microbiota in mother and newborn

  4. Microbiota composition in breast milk [ Time Frame: 0 months ]
    Composition of breast milk microbiota

  5. Microbiota composition in breast milk [ Time Frame: 2 months ]
    Composition of breast milk microbiota

  6. Microbiota composition in breast milk [ Time Frame: 4 months ]
    Composition of breast milk microbiota

  7. Microbiota composition in breast milk [ Time Frame: 6 months ]
    Composition of breast milk microbiota

  8. Non-caloric sweeteners levels at birth [ Time Frame: at birth ]
    Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL

  9. Non-caloric sweeteners levels 2 months follow-up [ Time Frame: 2 months after birth ]
    Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up

  10. Non-caloric sweeteners levels 4 months follow-up [ Time Frame: 4 months after birth ]
    Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up

  11. Non-caloric sweeteners levels 6 months follow-up [ Time Frame: 6 months after birth ]
    Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up


Biospecimen Retention:   Samples With DNA
Plasma Feces Breast milk Urine


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women in labor who come to the service of gynecology and obstetrics General Hospital Mexico. Usually, they are residents from Mexico City and metropolitan area (Mexico State).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912038


Contacts
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Contact: Marcela Esquivel, PhD +525527892000 ext 5652 esquivel.marcela@gmail.com

Locations
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Mexico
General Hospital of Mexico Dr. Eduardo Liceaga Recruiting
Mexico City, Mexico, 06726
Contact: Marcela Esquivel, PhD    5527892000    esquivel.marcela@gmail.com   
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
Investigators
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Principal Investigator: Marcela Esquivel, PhD Hospital General de México Dr. Eduardo Liceaga

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Responsible Party: Marcela Esquivel V, Medical Sciences Researcher, Hospital General de México Dr. Eduardo Liceaga
ClinicalTrials.gov Identifier: NCT03912038    
Other Study ID Numbers: DI/17/301/05/075
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcela Esquivel V, Hospital General de México Dr. Eduardo Liceaga:
Non-caloric sweeteners
microbiota
breast milk
umbilical cord
Additional relevant MeSH terms:
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Communicable Diseases
Infection