PainPhase 4NCT00733395
Hood to Coast Injury Study
A Phase 4 study testing Tart Cherry Juice and Fruit juice in people with Pain, run by Oregon Health and Science University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- Tart Cherry Juice and Fruit juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Comparison of Two Juice Drinks in Preventing the Symptoms of Muscle Pain Among Runners
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
- Being tested
- Tart Cherry Juice, Fruit juice
- Keywords
- Muscle pain
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart Cherry JuiceDietary supplement
Also called Cherrish
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).
Fruit juiceDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tart cherry juice Receives: Dietary Supplement: Tart Cherry Juice |
| 2 | Placebo comparator | Fruit juice Receives: Dietary Supplement: Fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post Race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Kuehl, Oregon Health and Science University
- Investigators
- Kerry S Kuehl, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733395
- Sponsor's protocol ID
- e4652
- Status last verified
- Jun 2019
- First submitted
- 11 Aug 2008
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Juice Drinks in Preventing the Symptoms of Muscle Pain Among Runners
- ClinicalTrials.gov ID
- NCT00733395
- Acronym / sponsor ID
- e4652
- Conditions
- Pain
- Keywords
- Muscle pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Tart Cherry JuiceTart cherry juice |
| 2 | Placebo comparator | Dietary Supplement: Fruit juiceFruit juice |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tart Cherry JuiceAlso: CherrishParticipants 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). | Dietary supplement | 1 |
| Fruit juiceParticipants 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. | Dietary supplement | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Kuehl, MD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tart Cherry Juice and Fruit juice in people with Pain, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.