InjuryPhase 1/2NCT01444170
Nutritional Supplement, Eccentric Exercise and Recovery
A Phase 1/2 study testing dicreatinol sulfate in people with Injury and Inflammation, run by University of Florida at 1 site in United States.
Trial summary
The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury, Inflammation
- What is being tested?
- dicreatinol sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 1/2
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non-smoking
- Untrained young adult males and females (age 18-25 years)
- Free of vitamin/mineral supplementation for six weeks prior to the study
Who cannot join
- Pregnant or positive pregnancy test
- Persons involved in a regular weight-training program within the last six weeks or with a prior history (within the last 6 weeks) of injury to the biceps brachii or elbow region
- Recent history or current reported use of anti-inflammatory medication, and active weight loss > 5 kg in prior 3 months (intended or unintended)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Exercise Science
Gainesville, Florida, 32611
About this study
Official title: A Single Site Double Blind Placebo Controlled Study of the Effects of a Dietary Supplement on Muscle Recovery Following Exercise-Induced Muscle Damage
The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. The investigators hypothesize that a short-term dietary supplementation will significantly improve muscle functional recovery following an intense bout of eccentric exercise compared to a placebo.
Read the detailed description
Impaired or incomplete recovery following high intensity exercise can negatively affect physical performance and delay functional progression, thereby reducing an athlete's chance of performing at his or her peak level. Athletes are constantly seeking ways to speed muscle recovery from strenuous exercise and muscle damage. Anabolic steroids are potent stimulators of muscle growth and repair and have been used extensively by athletes to hasten structural and functional recovery during peak periods of strenuous training. However, anabolic steroids are classified as banned substances by all major sports organizing committees that oversee and regulate amateur and professional athletics. In addition long-term use of anabolic steroids has known side effects that can negatively impact an athlete's health status. Dietary supplements are safe and viable alternatives that, if taken in the optimal doses, can provide positive effects on muscle growth and repair and ultimately human performance. Athletes have used dietary supplements extensively to facilitate tissue growth and repair following muscle-damaging events such as high-intensity resistance exercise and participation in contact sports. Following intense resistance exercise, an acute inflammatory response drives the repair process by synthesizing and releasing chemical mediators locally in the injured muscle. Inflammatory mediators help attract growth factors used for protein synthesis. The inflammatory response has also been shown to produce high levels of oxygen-derived free radicals that if allowed to proceed unabated, can produce further muscle damage, thus hindering the repair process. A protein-based dietary supplement, if taken in the optimal dosing schedule, may enhance the recovery process by blunting the magnitude of the acute inflammatory response and facilitating growth and repair through increased protein synthesis in damaged muscle tissue. Understanding the nutritional requirements of athletes engaged in high intensity training and competition is necessary to insure adequate recovery between exercise bouts. This will improve training and functional gains as well as act as a prophylaxis to skeletal muscle injury.
The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. This will be accomplished by evaluating baseline changes over the course of the recovery phase on severity of the symptomatic response and functional impairment in post-exercise skeletal muscle damage. The biceps brachii muscle will be targeted for this study. The investigators have established a safe and effective experimental arm curl model for inducing skeletal muscle soreness and dysfunction in human subjects using eccentric exercise to the bicep brachii muscle.
- Conditions
- Injury, Inflammation
- Being tested
- dicreatinol sulfate, placebo sugar pill
- Keywords
- eccentric exercise, exercise induce muscle damage, isometric strength, range of motion, self report symptoms, mechanical pain threshold
- Medical subject headings
- Wounds and Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dicreatinol sulfateDietary supplement
Also called Sham control
nutritional supplement
placebo sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Placebo "sugar" pill was used as a sham control Receives: Drug: placebo sugar pill |
| dicreatinol sulfate | Experimental | Not described Receives: Dietary Supplement: dicreatinol sulfate; Drug: placebo sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-reported symptoms and functional impairment at 10 days, 12 days, 14 days, 17 days and 20 days
Measured: 20 days
Secondary outcomes (3)
Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days
Measured: 20 days
Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days
Measured: 20 days
Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJul 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Responsible party
- Sponsor
- Investigators
- Paul A Borsa, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444170
- Sponsor's protocol ID
- IRB-316-2006
- Other IDs
- UPN06050404
- Status last verified
- Jul 2019
- First submitted
- 30 Jan 2008
- Last updated
- 15 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site Double Blind Placebo Controlled Study of the Effects of a Dietary Supplement on Muscle Recovery Following Exercise-Induced Muscle Damage
- ClinicalTrials.gov ID
- NCT01444170
- Acronym / sponsor ID
- IRB-316-2006
- Conditions
- Injury, Inflammation
- Keywords
- eccentric exercise, exercise induce muscle damage, isometric strength, range of motion, self report symptoms, mechanical pain threshold
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Sep 2011 (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 objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. The investigators hypothesize that a short-term dietary supplementation will significantly improve muscle functional recovery following an intense bout of eccentric exercise compared to a placebo.
Detailed description
Impaired or incomplete recovery following high intensity exercise can negatively affect physical performance and delay functional progression, thereby reducing an athlete's chance of performing at his or her peak level. Athletes are constantly seeking ways to speed muscle recovery from strenuous exercise and muscle damage. Anabolic steroids are potent stimulators of muscle growth and repair and have been used extensively by athletes to hasten structural and functional recovery during peak periods of strenuous training. However, anabolic steroids are classified as banned substances by all major sports organizing committees that oversee and regulate amateur and professional athletics. In addition long-term use of anabolic steroids has known side effects that can negatively impact an athlete's health status. Dietary supplements are safe and viable alternatives that, if taken in the optimal doses, can provide positive effects on muscle growth and repair and ultimately human performance. Athletes have used dietary supplements extensively to facilitate tissue growth and repair following muscle-damaging events such as high-intensity resistance exercise and participation in contact sports. Following intense resistance exercise, an acute inflammatory response drives the repair process by synthesizing and releasing chemical mediators locally in the injured muscle. Inflammatory mediators help attract growth factors used for protein synthesis. The inflammatory response has also been shown to produce high levels of oxygen-derived free radicals that if allowed to proceed unabated, can produce further muscle damage, thus hindering the repair process. A protein-based dietary supplement, if taken in the optimal dosing schedule, may enhance the recovery process by blunting the magnitude of the acute inflammatory response and facilitating growth and repair through increased protein synthesis in damaged muscle tissue. Understanding the nutritional requirements of athletes engaged in high intensity training and competition is necessary to insure adequate recovery between exercise bouts. This will improve training and functional gains as well as act as a prophylaxis to skeletal muscle injury.
The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. This will be accomplished by evaluating baseline changes over the course of the recovery phase on severity of the symptomatic response and functional impairment in post-exercise skeletal muscle damage. The biceps brachii muscle will be targeted for this study. The investigators have established a safe and effective experimental arm curl model for inducing skeletal muscle soreness and dysfunction in human subjects using eccentric exercise to the bicep brachii muscle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: placebo sugar pillPlacebo "sugar" pill was used as a sham control |
| dicreatinol sulfate | Experimental | Dietary Supplement: dicreatinol sulfate, Drug: placebo sugar pill |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Non-smoking
- Untrained young adult males and females (age 18-25 years)
- Free of vitamin/mineral supplementation for six weeks prior to the study
Key exclusion criteria (3 listed)
- Pregnant or positive pregnancy test
- Persons involved in a regular weight-training program within the last six weeks or with a prior history (within the last 6 weeks) of injury to the biceps brachii or elbow region
- Recent history or current reported use of anti-inflammatory medication, and active weight loss > 5 kg in prior 3 months (intended or unintended)
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 |
|---|---|---|
| dicreatinol sulfateAlso: Sham controlnutritional supplement | Dietary supplement | dicreatinol sulfate |
| placebo sugar pill | Drug | Sugar pill, dicreatinol sulfate |
Primary outcome
Change from baseline in self-reported symptoms and functional impairment at 10 days, 12 days, 14 days, 17 days and 20 days
Time frame: 20 days
3 secondary outcomes
Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days
Time frame: 20 days
Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days
Time frame: 20 days
Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days
Time frame: 20 days
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 15 Jul 2019.
- Iovate Health Sciences Research, Inc.Link provided by the sponsor.
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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.
Paul A Borsa, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dicreatinol sulfate in people with Injury and Inflammation, run by University of Florida 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 4 inclusion and 3 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 15 Jul 2019. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in self-reported symptoms and functional impairment at 10 days, 12 days, 14 days, 17 days and 20 days (time frame: 20 days). 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 15 Jul 2019.