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

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: Exercise Performance Recovery
• Intervention / Treatment: Other: Placebo: Microcrystalline Cellulose; Dietary supplement: XSurge; Other: Control: No supplementation

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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	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

Collaborators and Investigators

• Sponsor: Kemin Foods LC

Publications and helpful links

General 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.

Study record dates

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