Comparison of Gut Microbiota in Sedentary and Active Women | NCT02901912

Studies
Comparison of Gut Microbiota in Sedentary and Active Women

NCT02901912

Sponsor

Universidad Europea de Madrid

Status

Completed

Last Update Posted

Sep 15, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Sedentary

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 27, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2016

Last Update Posted Date

Sep 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Gut microbiota comparison of active and sedentary women

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active		Women who perform at least 3h of physical activity per week
Sedentary		Women who did not perform any kind of exercise

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mar Larrosa, PhD	Universidad Europea de Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mar Larrosa		Villaviciosa de Odón	Madrid	28670	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057185	Sedentary Behavior
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided