Muscle DamageNCT06432868
Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise
A study testing Solarplast (R) in people with Muscle Damage, run by Kent State University at 1 site in United States.
Trial summary
The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are: Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise? Does… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Solarplast (R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 31 Mar 2025
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.
- Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)
- Subject has a body mass index of 18.0-34.9 kg/m2, inclusive
- Subject is willing to maintain habitual diet throughout the study period
- Subject is willing to abstain from dietary supplementation throughout the duration of the study.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators
Who cannot join
- Subject is currently or will be enrolled in another clinical trial.
- Subject is a habitual consumer of tea/antioxidants defined as > 8 oz/day of either green or black tea within the 14 days prior to the screening visit.
- Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Subject is unable to perform physical exercise (determined by health and activity questionnaire)
- Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
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- Subject is allergic to the study product or placebo
- Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire)
- Subject has any chronic illness that causes continuous medical care
- Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kent State University - Exercise Science & Exercise Physiology
Kent, Ohio, 44242
Adam R Jajtner, PhD, 330-672-0212 ext. 20212, ajajtner@kent.edu
About this study
Official title: Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise
The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are:
Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise?
Read more
Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise?
Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery.
Participants will be asked to:
Take Solarplast (R) or placebo daily for 4 weeks
Visit the laboratory at least once per week to receive their supplement
Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.
- Conditions
- Muscle Damage
- Being tested
- Solarplast (R), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solarplast (R)Dietary supplement
Daily supplementation for 28 days prior to heavy resistance exercise.
PlaceboDietary supplement
Daily supplementation for 28 days prior to heavy resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| Solarplast (R) | Active comparator | 100mg/day of Solarplast (R) supplementation (28 days). Receives: Dietary Supplement: Solarplast (R) |
| Placebo | Placebo comparator | 100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine Kinase Activity
Marker of Muscle Damage
Measured: Acute changes following exercise for 48 hours
Secondary outcomes (7)
Myoglobin Concentration
Marker of Muscle Damage
Measured: Acute changes following exercise for 24 hours
Vertical Jump Height
Measure of Performance Change
Measured: Acute changes following exercise for 48 hours
Mean Squat Velocity
Measure of Performance Change
Measured: Acute changes following exercise for 48 hours
Peak Isometric Muscle Force
Measure of Performance Change
Measured: Acute changes following exercise for 48 hours
Rate of Force Development
Measure of Performance Change
Measured: Acute changes following exercise for 48 hours
Ratings of Perceived Soreness
Visual Analog Scale (1-100mm; low values indicate reduced soreness)
Measured: Acute changes following exercise for 48 hours
Ratings of Perceived Fatigue
Visual Analog Scale (1-100mm; low values indicated reduced fatigue)
Measured: Acute changes following exercise for 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start17 Apr 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Jajtner, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432868
- Sponsor's protocol ID
- 927
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise
- ClinicalTrials.gov ID
- NCT06432868
- Acronym / sponsor ID
- 927
- Conditions
- Muscle Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 29 May 2024 (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.
The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are:
Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise?
Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise?
Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery.
Participants will be asked to:
Take Solarplast (R) or placebo daily for 4 weeks
Visit the laboratory at least once per week to receive their supplement
Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solarplast (R) | Active comparator | Dietary Supplement: Solarplast (R)100mg/day of Solarplast (R) supplementation (28 days). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.
- Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)
- Subject has a body mass index of 18.0-34.9 kg/m2, inclusive
- Subject is willing to maintain habitual diet throughout the study period
- Subject is willing to abstain from dietary supplementation throughout the duration of the study.
Key exclusion criteria (10 listed)
- Subject is currently or will be enrolled in another clinical trial.
- Subject is a habitual consumer of tea/antioxidants defined as > 8 oz/day of either green or black tea within the 14 days prior to the screening visit.
- Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Subject is unable to perform physical exercise (determined by health and activity questionnaire)
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 |
|---|---|---|
| Solarplast (R)Daily supplementation for 28 days prior to heavy resistance exercise. | Dietary supplement | Solarplast (R) |
| PlaceboDaily supplementation for 28 days prior to heavy resistance exercise. | Dietary supplement | Placebo |
Primary outcome
Creatine Kinase Activity
Time frame: Acute changes following exercise for 48 hours
Marker of Muscle Damage
7 secondary outcomes
Myoglobin Concentration
Time frame: Acute changes following exercise for 24 hours
Vertical Jump Height
Time frame: Acute changes following exercise for 48 hours
Mean Squat Velocity
Time frame: Acute changes following exercise for 48 hours
Peak Isometric Muscle Force
Time frame: Acute changes following exercise for 48 hours
Rate of Force Development
Time frame: Acute changes following exercise for 48 hours
Ratings of Perceived Soreness
Time frame: Acute changes following exercise for 48 hours
Ratings of Perceived Fatigue
Time frame: Acute changes following exercise for 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solarplast (R) in people with Muscle Damage, run by Kent State 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 6 inclusion and 10 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 29 May 2024. 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.
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 Adam R Jajtner, PhD (330-672-0212 ext. 20212, ajajtner@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine Kinase Activity (time frame: Acute changes following exercise for 48 hours). 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 29 May 2024.