Post-exercise Muscle SorenessNCT03510806
Nutritional Supplements for Exercise Recovery
A study testing Supplement in people with Post-exercise Muscle Soreness, run by Catherine Mikus at 1 site in United States.
Trial summary
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-exercise Muscle Soreness
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 1 Jul 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to consume supplement
- Willing to adhere to the study intervention regimen
- Willing to abstain from analgesics for duration of the study
- Agreement to adhere to Lifestyle Considerations
Who cannot join
- Current use of NSAIDs
- Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes
- Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions
- Weight > 350 pounds
- Pregnancy or lactation
- Known food allergies or sensitivities or dietary restrictions
Show all 12Show fewer
- Habitual consumption of > 2 alcoholic drinks per day
- Febrile illness or antibiotic use within 1 month prior to baseline testing
- Treatment with another investigational drug or other intervention within 1 month
- Current smoker or tobacco use within 1 month
- Any condition(s) or diagnosis, both physical or psychological, that, in the opinion of the principal investigator or study physician, precludes participation and/or ability to consent
- Any other factor that, in the opinion of the principal investigator or study physician, would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Nutritional Supplements for Exercise Recovery
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.
- Conditions
- Post-exercise Muscle Soreness
- Being tested
- Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
dietary supplement contain protein from milk and fruit extract
PlaceboOther
color, taste, and calorie-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | taste, color, and calorie-matched to supplement Receives: Other: Placebo |
| Supplement | Experimental | Proprietary protein and fruit extract blend Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-exercise muscle soreness
VAS score
Measured: 7 days
Secondary outcomes (4)
post-exercise muscle strength
countermovement jump performance
Measured: 7 days
post-exercise muscle function
repetitive countermovement jumps
Measured: 7 days
satiety
VAS scores
Measured: 4-5 hours
sleep quality
sleep metrics, Fitbit
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start20 Mar 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-exercise 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Mikus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Catherine Mikus, Beachbody
- Investigators
- Catherine R Mikus, PhD, Principal investigator, Beachbody, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510806
- Sponsor's protocol ID
- 03132018BB
- Status last verified
- Feb 2019
- First submitted
- 14 Mar 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Supplements for Exercise Recovery
- ClinicalTrials.gov ID
- NCT03510806
- Acronym / sponsor ID
- 03132018BB
- Conditions
- Post-exercise Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Catherine MikusIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Apr 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.
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebotaste, color, and calorie-matched to supplement |
| Supplement | Experimental | Dietary Supplement: SupplementProprietary protein and fruit extract blend |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to consume supplement
- Willing to adhere to the study intervention regimen
- Willing to abstain from analgesics for duration of the study
- Agreement to adhere to Lifestyle Considerations
Key exclusion criteria (12 listed)
- Current use of NSAIDs
- Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes
- Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions
- Weight > 350 pounds
- Pregnancy or lactation
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 |
|---|---|---|
| Supplementdietary supplement contain protein from milk and fruit extract | Dietary supplement | Supplement |
| Placebocolor, taste, and calorie-matched placebo | Other | Placebo |
Primary outcome
post-exercise muscle soreness
Time frame: 7 days
VAS score
4 secondary outcomes
post-exercise muscle strength
Time frame: 7 days
post-exercise muscle function
Time frame: 7 days
satiety
Time frame: 4-5 hours
sleep quality
Time frame: 15 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 27 Feb 2019.
- 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.
Catherine R Mikus, PhD principal investigator
Beachbody, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Post-exercise Muscle Soreness, run by Catherine Mikus 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 12 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 27 Feb 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.
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?
post-exercise muscle soreness (time frame: 7 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 27 Feb 2019.