Comparison of Gut Microbiota in Sedentary and Active Women

September 9, 2016 updated by: Mar Larrosa, Universidad Europea de Madrid

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

Gut microbiota comparison of active and sedentary women

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Villaviciosa de Odón, Madrid, Spain, 28670
        • Mar Larrosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 7 days
Physical activity was determined by accelerometry
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: One year
Gut microbiota determination by 16S rRNA Sequencing
One year
Diet
Time Frame: 6 months
Diet was determined with a food frequency questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Investigators

  • Principal Investigator: Mar Larrosa, PhD, Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UEM0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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