NCT02901912

Brief Summary

Gut microbiota comparison of active and sedentary women

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

July 27, 2016

Last Update Submit

September 9, 2016

Conditions

Sedentary

Keywords

physical activitysedentarismfecal enzymatic activity

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Physical activity was determined by accelerometry

    7 days

Secondary Outcomes (2)

  • Gut microbiota

    One year

  • Diet

    6 months

Study Arms (2)

Active

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

Sedentary

Women who did not perform any kind of exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy women who do not perform exercise at all or practice at least 3 hours of exercise per week

You may qualify if:

  • healthy women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mar Larrosa

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA extracted from feces

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mar Larrosa, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 27, 2016

First Posted

September 15, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

July 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

ES(1)