Hood to Coast Injury Study

NCT ID: NCT00733395

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

1

Tart cherry juice

Group Type: EXPERIMENTAL

Tart Cherry Juice

Intervention Type: DIETARY_SUPPLEMENT

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).

2

Fruit juice

Group Type: PLACEBO_COMPARATOR

Fruit juice

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cherrish

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Kerry Kuehl

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerry S Kuehl, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Other Identifiers

e4652

Identifier Type: -

Identifier Source: org_study_id