Exercise Performance RecoveryNCT02442245
The Effect of XSurge Supplementation on Biomarkers and Performance From High Intensity Resistance Exercise
A study testing XSurge in people with Exercise Performance Recovery, run by Kemin Foods LC at 1 site in United States.
Trial summary
Part one of this study will consist of baseline (BL) testing, 28 days of daily supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists of five visits, of which, the first visit will consist of maximal strength testing. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance Recovery
- What is being tested?
- XSurge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2016
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active.
- Subject is judged by the Investigator to be healthy and free of any physical limitations
- Subject is male 18-35 y of age, inclusive
- Subject has a body mass index of 18.0-34.9 kg/m2
- Subject is willing to maintain habitual diet
- Subject is willing to abstain from dietary supplementation
- 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 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
- Subject is a current smoker or has quit within the last 6 months
- Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
Show all 11Show fewer
- Subject is allergic to the study product or placebo
- Subject is taking any other nutritional supplement or performance enhancing drug
- Subjects that have donated blood or plasma within the previous week
- 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.
About this study
Official title: The Effect of XSurgeTM Supplementation on Biomarkers, Oxidative Stress, and Recovery From High Intensity Resistance Exercise
Part one of this study will consist of baseline (BL) testing, 28 days of daily supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists of five visits, of which, the first visit will consist of maximal strength testing. The remaining visits will consist of performance testing and muscle evaluation.
Phase two of this study will consist of six weeks of supervised resistance training along with supplementation of XSurge. Following the six weeks of training, subjects will complete a second acute exercise protocol. Measures to be evaluated will consist of performance testing and muscle evaluation.
- Conditions
- Exercise Performance Recovery
- Being tested
- XSurge, Placebo: Microcrystalline Cellulose, Control: No supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSurgeDietary supplement
During part one of the study, 28 days of supplementation with XSurge will be provided. During the second part of the study 6 weeks of supplementation with XSurge will accompany a training program.
Placebo: Microcrystalline CelluloseOther
Control: No supplementationOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo group will receive microcrystalline cellulose Receives: Other: Placebo: Microcrystalline Cellulose |
| Treatment | Active comparator | Treatment group will get 2 g daily of XSurge in microcrystalline cellulose Receives: Dietary Supplement: XSurge |
| Control Group | Sham comparator | The control group will be included to quantify or describe the effects of the acute exercise training but will not receive any supplement Receives: Other: Control: No supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength as measured by Peak Torque (Biodex)
Measured: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Biomarkers (Cortisol and Creatine Phosphokinase)
Measured: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Secondary outcomes (2)
Subjective Feelings of Recovery (Likert Scale)
Measured: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Muscle Soreness (VAS)
Measured: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Performance RecoveryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442245
- Sponsor's protocol ID
- 14HUS002
- Status last verified
- Jan 2018
- First submitted
- 30 Apr 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
Publications
Jajtner AR, Townsend JR, Beyer KS, Varanoske AN, Church DD, Oliveira LP, Herrlinger KA, Radom-Aizik S, Fukuda DH, Stout JR, Hoffman JR. Resistance Exercise Selectively Mobilizes Monocyte Subsets: Role of Polyphenols. Med Sci Sports Exerc. 2018 Nov;50(11):2231-2241. doi: 10.1249/MSS.0000000000001703.
PubMed 29957728
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of XSurgeTM Supplementation on Biomarkers, Oxidative Stress, and Recovery From High Intensity Resistance Exercise
- ClinicalTrials.gov ID
- NCT02442245
- Acronym / sponsor ID
- 14HUS002
- Conditions
- Exercise Performance Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 May 2015 (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.
Part one of this study will consist of baseline (BL) testing, 28 days of daily supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists of five visits, of which, the first visit will consist of maximal strength testing. The remaining visits will consist of performance testing and muscle evaluation.
Phase two of this study will consist of six weeks of supervised resistance training along with supplementation of XSurge. Following the six weeks of training, subjects will complete a second acute exercise protocol. Measures to be evaluated will consist of performance testing and muscle evaluation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo: Microcrystalline CellulosePlacebo group will receive microcrystalline cellulose |
| Treatment | Active comparator | Dietary Supplement: XSurgeTreatment group will get 2 g daily of XSurge in microcrystalline cellulose |
| Control Group | Sham comparator | Other: Control: No supplementationThe control group will be included to quantify or describe the effects of the acute exercise training but will not receive any supplement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Recreationally active.
- Subject is judged by the Investigator to be healthy and free of any physical limitations
- Subject is male 18-35 y of age, inclusive
- Subject has a body mass index of 18.0-34.9 kg/m2
- Subject is willing to maintain habitual diet
Key exclusion criteria (11 listed)
- Subject is currently or will be enrolled in another clinical trial.
- 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
- Subject is a current smoker or has quit within the last 6 months
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 |
|---|---|---|
| XSurgeDuring part one of the study, 28 days of supplementation with XSurge will be provided. During the second part of the study 6 weeks of supplementation with XSurge will accompany a training program. | Dietary supplement | Treatment |
| Placebo: Microcrystalline Cellulose | Other | Placebo |
| Control: No supplementation | Other | Control Group |
Primary outcome
Strength as measured by Peak Torque (Biodex)
Time frame: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Biomarkers (Cortisol and Creatine Phosphokinase)
Time frame: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
2 secondary outcomes
Subjective Feelings of Recovery (Likert Scale)
Time frame: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
Muscle Soreness (VAS)
Time frame: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise
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 31 Jan 2018.
- Derived from this study: PubMed 29957728Jajtner AR, Townsend JR, Beyer KS, Varanoske AN, Church DD, Oliveira LP, Herrlinger KA, Radom-Aizik S, Fukuda DH, Stout JR, Hoffman JR. Resistance Exercise Selectively Mobilizes Monocyte Subsets: Role of Polyphenols. Med Sci Sports Exerc. 2018 Nov;50(11):2231-2241. doi: 10.1249/MSS.0000000000001703.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XSurge in people with Exercise Performance Recovery, run by Kemin Foods LC 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 7 inclusion and 11 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 31 Jan 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.
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?
Strength as measured by Peak Torque (Biodex) (time frame: Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise). The study lists 2 primary outcomes in all. 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 NCT02442245, which also lists 1 linked publication.
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 31 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.