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

January 29, 2018 updated by: Kemin Foods LC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States
        • University of Central Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo group will receive microcrystalline cellulose
Other: Placebo: Microcrystalline Cellulose
Active Comparator: Treatment
Treatment group will get 2 g daily of XSurge in microcrystalline cellulose
Dietary supplement: XSurge
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.
Sham Comparator: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Time Frame
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
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
Part 1-Change from baseline after 28 days of supplementation; Part 2-Change from baseline after 6 weeks of supplementation plus exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kemin Foods LC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 14HUS002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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