Muscle SorenessPhase 1PRSRENCT03540602
Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
A Phase 1 study testing Tart Cherry in people with Muscle Soreness, run by Jacksonville University at 1 site in United States.
Trial summary
Strength training is commonly used as an intervention to increase muscle mass, thus improving a person's ability to undertake activities of daily living, or enhance athletic performance. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Tart Cherry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to Aug 2018
- Phase
- Phase 1
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 6 months of resistance training experience with barbel back squat exercise
Who cannot join
- Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jacksonville University
Jacksonville, Florida, 32211
Heather Hausenblaus, PhD, 410-256-7975, hhausen@ju.edu
David Hooper, PhD, 904-256-7985, dhooper4@ju.edu
About this study
Strength training is commonly used as an intervention to increase muscle mass, thus improving a person's ability to undertake activities of daily living, or enhance athletic performance. The strength training regimen itself, while ultimately having beneficial effects, causes muscle fibers to be damaged, which the body has to recover from. As the body recovers, it rebuilds the muscle tissue and after multiple consecutive bouts of strength training, the muscle eventually becomes larger and stronger. Thus, it is the recovery from strength training exercise that ultimately determines how well the body adapts. Where inadequate recovery could eventually lead to overtraining and/or injury, optimizing the recovery process from strength training could maximize strength training adaptations. This concept of optimizing recovery has led to development of many supplements, including antioxidants, which may reduce the damage associated with strength training activities and therefore enhance positive adaptations. The purpose of this study is to assess the ability of a polyphenol rich supplementation to aid the recovery process from a demanding bout of resistance exercise
- Conditions
- Muscle Soreness
- Being tested
- Tart Cherry, Placebo Oral Capsule [CEBOCAP]
- Keywords
- Polyphenol rich supplementation, Tart cherry, Lifting, Recovery
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart CherryDietary supplement
Also called NordicCherry Tart Cherry Extract Powder 500 mg
NordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc
Placebo Oral Capsule [CEBOCAP]Other
Rice flour
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Rice flour capsule Receives: Other: Placebo Oral Capsule [CEBOCAP] |
| Polyphenol Rich Supplement | Active comparator | NordicCherry Tart Cherry Extract Powder 500 mg in capsule form Receives: Dietary Supplement: Tart Cherry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Oxidative Stress
Blood analyses will be used, 8 mL of blood will be taken from the participant six times per condition. The blood will be centrifuged to separate the serum/ plasma and analyzed by enzyme- linked immunosorbent assay (ELISA) for c- reactive protein and creatine kinase, and oxidative damage
Measured: 7 weeks
Secondary outcomes (2)
Muscle soreness
Subjects will mark a line on a 10cm scale that corresponds to the amount of muscular soreness they currently perceive
Measured: 7 weeks
Vertical Jump Performance
Subjects will be instructed to stand on a NeuroCom Balance Manager forceplate with hands on hips. Subjects will then be instructed to perform 3 consecutive vertical jumps, as high as possible with minimal time between jumps. The jumps will later be assessed for power production.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2018
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 20 male participants will start with a familiarization visit where they will receive either the placebo supplement or the polyphenol rich supplement that they will take for 7 days. After taking the supplement, the participants will come back and run through the acute resistance exercise protocol as well as return the next day for a post test. Next, the participants will undergo a "wash out" phase where they will not take any supplementation. At the end of these 2 weeks, the participants will then take the other supplement (i.e. if they took the polyphenol rich supplement in the first phase they will take the placebo supplement in the second phase). After a week of taking their assigned supplement, participants will complete the acute resistance exercise protocol and the post test.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacksonville University
- Sponsor type
- University, hospital or other
- Collaborators
- Specnova, inc
- Responsible party
- Sponsor
- Investigators
- Heather Hausenblaus, Principal investigator, Jacksonville University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540602
- Sponsor's protocol ID
- Polyphenol Supplementation
- Acronym
- PRSRE
- Status last verified
- May 2018
- First submitted
- 26 Feb 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reid MB. Invited Review: redox modulation of skeletal muscle contraction: what we know and what we don't. J Appl Physiol (1985). 2001 Feb;90(2):724-31. doi: 10.1152/jappl.2001.90.2.724.
PubMed 11160074Alessio HM, Goldfarb AH, Cutler RG. MDA content increases in fast- and slow-twitch skeletal muscle with intensity of exercise in a rat. Am J Physiol. 1988 Dec;255(6 Pt 1):C874-7. doi: 10.1152/ajpcell.1988.255.6.C874.
PubMed 3202155Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.
PubMed 11427763Powers SK, Jackson MJ. Exercise-induced oxidative stress: cellular mechanisms and impact on muscle force production. Physiol Rev. 2008 Oct;88(4):1243-76. doi: 10.1152/physrev.00031.2007.
PubMed 18923182
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
- ClinicalTrials.gov ID
- NCT03540602
- Acronym / sponsor ID
- PRSRE / Polyphenol Supplementation
- Conditions
- Muscle Soreness
- Keywords
- Polyphenol rich supplementation, Tart cherry, Lifting, Recovery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jacksonville UniversityUniversity, hospital or other
- Collaborators
- Specnova, inc
- Study start
- 1 May 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 30 May 2018 (actual)
- 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.
Strength training is commonly used as an intervention to increase muscle mass, thus improving a person's ability to undertake activities of daily living, or enhance athletic performance. The strength training regimen itself, while ultimately having beneficial effects, causes muscle fibers to be damaged, which the body has to recover from. As the body recovers, it rebuilds the muscle tissue and after multiple consecutive bouts of strength training, the muscle eventually becomes larger and stronger. Thus, it is the recovery from strength training exercise that ultimately determines how well the body adapts. Where inadequate recovery could eventually lead to overtraining and/or injury, optimizing the recovery process from strength training could maximize strength training adaptations. This concept of optimizing recovery has led to development of many supplements, including antioxidants, which may reduce the damage associated with strength training activities and therefore enhance positive adaptations. The purpose of this study is to assess the ability of a polyphenol rich supplementation to aid the recovery process from a demanding bout of resistance exercise
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 20 male participants will start with a familiarization visit where they will receive either the placebo supplement or the polyphenol rich supplement that they will take for 7 days. After taking the supplement, the participants will come back and run through the acute resistance exercise protocol as well as return the next day for a post test. Next, the participants will undergo a "wash out" phase where they will not take any supplementation. At the end of these 2 weeks, the participants will then take the other supplement (i.e. if they took the polyphenol rich supplement in the first phase they will take the placebo supplement in the second phase). After a week of taking their assigned supplement, participants will complete the acute resistance exercise protocol and the post test.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo Oral Capsule [CEBOCAP]Rice flour capsule |
| Polyphenol Rich Supplement | Active comparator | Dietary Supplement: Tart CherryNordicCherry Tart Cherry Extract Powder 500 mg in capsule form |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 6 months of resistance training experience with barbel back squat exercise
Key exclusion criteria (1 listed)
- Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.
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 CherryAlso: NordicCherry Tart Cherry Extract Powder 500 mgNordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc | Dietary supplement | Polyphenol Rich Supplement |
| Placebo Oral Capsule [CEBOCAP]Rice flour | Other | Placebo |
Primary outcome
Assessment of Oxidative Stress
Time frame: 7 weeks
Blood analyses will be used, 8 mL of blood will be taken from the participant six times per condition. The blood will be centrifuged to separate the serum/ plasma and analyzed by enzyme- linked immunosorbent assay (ELISA) for c- reactive protein and creatine kinase, and oxidative damage
2 secondary outcomes
Muscle soreness
Time frame: 7 weeks
Vertical Jump Performance
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 11160074Reid MB. Invited Review: redox modulation of skeletal muscle contraction: what we know and what we don't. J Appl Physiol (1985). 2001 Feb;90(2):724-31. doi: 10.1152/jappl.2001.90.2.724.
- Results publication: PubMed 3202155Alessio HM, Goldfarb AH, Cutler RG. MDA content increases in fast- and slow-twitch skeletal muscle with intensity of exercise in a rat. Am J Physiol. 1988 Dec;255(6 Pt 1):C874-7. doi: 10.1152/ajpcell.1988.255.6.C874.
- Results publication: PubMed 11427763Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.
- Results publication: PubMed 18923182Powers SK, Jackson MJ. Exercise-induced oxidative stress: cellular mechanisms and impact on muscle force production. Physiol Rev. 2008 Oct;88(4):1243-76. doi: 10.1152/physrev.00031.2007.
- Individual participant dataSharing planned: Undecided
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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.
Heather Hausenblaus principal investigator
Jacksonville University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tart Cherry in people with Muscle Soreness, run by Jacksonville University at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Hausenblaus (904-256-7975, hhausen@ju.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Oxidative Stress (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540602, which also lists 4 linked publications.
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 30 May 2018.