NCT01113827

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable healthy

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

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 27, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

April 28, 2010

Last Update Submit

March 23, 2012

Conditions

Healthy

Keywords

OliveantioxidantexerciseinflammationrecoveryHealthy men

Outcome Measures

Primary Outcomes (1)

  • Improved Antioxidant Status

    6 weeks

Secondary Outcomes (1)

  • Reduced Inflammation

    6 weeks

Study Arms (3)

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

Olive ExtractDIETARY_SUPPLEMENT

Capsule form ingested 1x/day for 6 weeks

150mg olive extract50mg olive extract
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo control

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreational exerciser
  • BMI \<= 30
  • Non-smoker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Motor ActivityInflammation

Interventions

olive extract

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Ivy, Ph.D.

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2011

Study Completion

February 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-02

Locations

US(1)