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OpenTrials
Completed

NCT Number: NCT02442245

The Effect of XSurge Supplementation on Biomarkers and Performance 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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XSurge

Dietary 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 Cellulose

Other

Control: No supplementation

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Kemin Foods LC

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 13, 2015
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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