The Effect of XSurge Supplementation on Biomarkers and Performance From High Intensity Resistance Exercise

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of XSurgeTM Supplementation on Biomarkers, Oxidative Stress, and Recovery From High Intensity Resistance Exercise

Conditions
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Exercise Performance Recovery

Intervention / Treatment
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* Dietary Supplement: XSurge
* Other: Placebo: Microcrystalline Cellulose
* Other: Control: No supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo group will receive microcrystalline cellulose | Other: Placebo: Microcrystalline Cellulose<br> <br> |
| Active Comparator: Treatment<br>Treatment group will get 2 g daily of XSurge in microcrystalline cellulose | Dietary Supplement: XSurge<br>* 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.<br>|
| Sham Comparator: Control Group<br>The control group will be included to quantify or describe the effects of the acute exercise training but will not receive any supplement | Other: Control: No supplementation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength as measured by Peak Torque (Biodex) |  | 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) |  | Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Feelings of Recovery (Likert Scale) |  | 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) |  | Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise |