Effects of Water-soluble Olive Extract Supplementation | NCT01113827

Studies
Effects of Water-soluble Olive Extract Supplementation

NCT01113827

Sponsor

University of Texas at Austin

Status

Completed

Last Update Posted

Mar 27, 2012Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Olive Extract
Placebo

Countries

United States

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

Feb 2012

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

Feb 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

Apr 29, 2010

First Posted Date

Apr 30, 2010Estimated

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

Mar 23, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Name	Class
dsm-firmenich Switzerland AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Six weeks of supplementation of an olive extract will:

Improve antioxidant status
Reduce inflammation
Reduce muscle damage
Improve exercise performance
Improve exercise recovery as compared to a placebo.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
150mg olive extract	Active Comparator	Dietary Supplement: Olive Extract
50mg olive extract	Active Comparator	Dietary Supplement: Olive Extract
Placebo control	Placebo Comparator	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olive Extract	Dietary Supplement	Capsule form ingested 1x/day for 6 weeks	150mg olive extract 50mg olive extract

Measure	Description	Time Frame
Improved Antioxidant Status		6 weeks

Measure	Description	Time Frame
Reduced Inflammation		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recreational exerciser
BMI <= 30
Non-smoker

Exclusion Criteria:

Blood pressure over 140/90
Type I or Type II diabetes
Renal, hepatic or cardiac disease
Current infectious disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Ivy, Ph.D.	The University of Texas at Austin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas at Austin		Austin	Texas	78712	United States

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D007249	Inflammation

Ancestor Terms

ID	Term
D001519	Behavior
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000627506	olive extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided