Hood to Coast Injury Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Oregon Health and Science University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00733395
First received: August 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The purpose of this study is to examine how certain kinds of fruit juice that contain natural antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain and injury. Participants will be recruited from registered participants in the Hood To Coast Relay. The Hood To Coast Relay Race Officials will post the study on their website to find interested teams. Interested participants will then be contacted by the study staff by phone regarding the study's inclusion and exclusion criteria and to schedule the initial health screening visit. The participants will undergo an initial health screening and survey about muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th day of drink administration, the participants will report to the starting location of the Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and juice tolerability. The participants will then participate in the Hood To Coast Relay, drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the relay, the participants will meet with study investigators to take the same short survey about muscle pain and juice tolerability.


Condition Intervention Phase
Pain
Dietary Supplement: Tart Cherry Juice
Dietary Supplement: Fruit juice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparison of Two Juice Drinks in Preventing the Symptoms of Muscle Pain Among Runners

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • The administration of tart cherry juice will reduce the symptoms of exercise-induced muscle damage as measured by patients assessment of pain on a standard VAS. [ Time Frame: Post Race ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tart cherry juice
Dietary Supplement: Tart Cherry Juice
Participants will ingest 10.5 fl oz of cherry juice twice a day for 7 days prior to the race, and the day of the race (8 days total).
Other Name: Cherrish
Placebo Comparator: 2
Fruit juice
Dietary Supplement: Fruit juice
Participants will ingest 10.5 fl oz of fruit juice twice a day for 7 days prior to the race, and the day of the race (8 days total), which will serve as a 'placebo' juice.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability and willingness not to take any anti-inflammatory or pain relieving drugs during the course of the study, and not to seek any other treatment for any symptoms of muscle damage until completion of the study after the race.

Exclusion Criteria:

  • The investigators will exclude individuals who have or are using antiepileptic drugs for pain, acupuncture, or transcutaneous electrical nerve stimulation within 3 weeks before enrollment
  • Recent use (within 5 half-lives) of topical medications/anesthetics, muscle relaxants, tender point anesthetic injections within 2 months, systemic steroids within 3 months or any investigational drug/device in the prior 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733395

Contacts
Contact: Kerry S Kuehl, MD 503-494-5991 kuehlk@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kerry S Kuehl, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kerry Kuehl, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00733395     History of Changes
Other Study ID Numbers: e4652
Study First Received: August 11, 2008
Last Updated: August 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Muscle pain

ClinicalTrials.gov processed this record on October 19, 2014