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

NCT02442245 | Completed

• 1 other identifier: 14HUS002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo group will receive microcrystalline cellulose

Other: Placebo: Microcrystalline Cellulose

Treatment

ACTIVE COMPARATOR

Treatment group will get 2 g daily of XSurge in microcrystalline cellulose

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

Other: Control: No supplementation

Interventions

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.

Treatment

Placebo: Microcrystalline Cellulose OTHER

Placebo

Control: No supplementation OTHER

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kemin Foods LC: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 29957728 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

US (1)