Pain Clinical Trial
Official title:
Comparison of Two Juice Drinks in Preventing the Symptoms of Muscle Pain Among Runners
| NCT number | NCT00733395 |
| Other study ID # | e4652 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | August 2008 |
| Est. completion date | June 2009 |
| Verified date | June 2019 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 65 |
| Est. completion date | June 2009 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Post Race |
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|---|---|---|---|
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