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NCT02901912 Clinical Trial

Comparison of Gut Microbiota in Sedentary and Active Women

Sedentary Clinical Trial

Official title:
Effect of Diet and Exercise in the Gut Microbiota of Premenopausal Women:Correlation With Inflammatory and Oxidative Stress Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02901912
Other study ID # UEM0001
Secondary ID
Status Completed
Phase N/A
First received July 27, 2016
Last updated September 9, 2016
Start date September 2014
Est. completion date July 2016

Study information
Verified date September 2016
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

Gut microbiota comparison of active and sedentary women

Description:

Observational study comparing gut microbiota of people who did not practice any physical exercise (sedentary) with the gut microbiota of people who at least practice exercise a minimum of 3 hours per week but they were not professional athletes. Since the hormonal status and gender are factors that influence gut microbiota, this study has been conducted in premenopausal women.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy women

Exclusion Criteria:

- Smokers, pregnant, vegetarian, vegan, taking antibiotics in the last 3 months, any kind of disease, body mass index>25

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Mar Larrosa Villaviciosa de Odón Madrid

Sponsors (1)
Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physical activity Physical activity was determined by accelerometry 7 days Yes
Secondary Gut microbiota Gut microbiota determination by 16S rRNA Sequencing One year Yes
Secondary Diet Diet was determined with a food frequency questionnaire 6 months Yes
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