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Effects of Water-soluble Olive Extract Supplementation

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01113827
First received: April 28, 2010
Last updated: March 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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.

Condition Intervention
Healthy
 Dietary Supplement: Olive Extract
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Water-soluble Olive Extract on Antioxidant Status, Exercise Performance, Muscle Metabolism, Muscle Damage and Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Improved Antioxidant Status [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduced Inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 150mg olive extract Dietary Supplement: Olive Extract
Capsule form ingested 1x/day for 6 weeks
Active Comparator: 50mg olive extract Dietary Supplement: Olive Extract
Capsule form ingested 1x/day for 6 weeks
Placebo Comparator: Placebo control Dietary Supplement: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113827

Locations
United States, Texas
The University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: John Ivy, Ph.D. The University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01113827     History of Changes
Other Study ID Numbers: 2009-09-01-OLIV
Study First Received: April 28, 2010
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Olive
antioxidant
exercise
 inflammation
recovery
Healthy men

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013