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Comparison of Gut Microbiota in Sedentary and Active Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02901912
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Information provided by (Responsible Party):
Mar Larrosa, Universidad Europea de Madrid

Brief Summary:
Gut microbiota comparison of active and sedentary women

Condition or disease

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

Women who perform at least 3h of physical activity per week
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

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 identifier (NCT number): NCT02901912

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Mar Larrosa
Villaviciosa de Odón, Madrid, Spain, 28670
Sponsors and Collaborators
Universidad Europea de Madrid
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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 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
fecal enzymatic activity