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Comparison of Gut Microbiota in Sedentary and Active Women

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ClinicalTrials.gov Identifier: NCT02901912
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mar Larrosa, Universidad Europea de Madrid

Brief Summary:
Gut microbiota comparison of active and sedentary women

Condition or disease
Sedentary

Detailed 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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Official Title: Effect of Diet and Exercise in the Gut Microbiota of Premenopausal Women:Correlation With Inflammatory and Oxidative Stress Parameters
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Active
Women who perform at least 3h of physical activity per week
Sedentary
Women who did not perform any kind of exercise



Primary Outcome Measures :
  1. Physical activity [ Time Frame: 7 days ]
    Physical activity was determined by accelerometry


Secondary Outcome Measures :
  1. Gut microbiota [ Time Frame: One year ]
    Gut microbiota determination by 16S rRNA Sequencing

  2. Diet [ Time Frame: 6 months ]
    Diet was determined with a food frequency questionnaire


Biospecimen Retention:   Samples With DNA
Bacterial DNA extracted from feces


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy women who do not perform exercise at all or practice at least 3 hours of exercise per week
Criteria

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

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): NCT02901912


Locations
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Spain
Mar Larrosa
Villaviciosa de Odón, Madrid, Spain, 28670
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Mar Larrosa, PhD Universidad Europea de Madrid

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Responsible Party: Mar Larrosa, Principal investigator, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT02901912     History of Changes
Other Study ID Numbers: UEM0001
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mar Larrosa, Universidad Europea de Madrid:
physical activity
sedentarism
fecal enzymatic activity