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Multi-ingredient Supplement for Strength and Power

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ClinicalTrials.gov Identifier: NCT01971723
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : March 13, 2015
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
East Carolina University
Information provided by (Responsible Party):
Florida State University

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE October 29, 2013
Results First Submitted Date  ICMJE January 5, 2015
Results First Posted Date  ICMJE March 13, 2015
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Strength Performance Outcomes [ Time Frame: Baseline measures and 4 weeks from start of study ]
    Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period. Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point.
  • Insulin Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Blood Lipid Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Total Testosterone Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Estrogen Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Insulin-like Growth Factor-I Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Bio-availableTestosterone Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Free Testosterone Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Dihydrotestosterone Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
    Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
  • Cortisol Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
  • Sex-hormone Binding Globulin Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
  • Creatine-Kinase Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Performance outcomes [ Time Frame: 4 weeks from start of study ]
Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period. During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Volume Performance Outcomes [ Time Frame: 4 Weeks ]
During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Physiological Outcomes [ Time Frame: 1 month from Completion of Study ]
Measurements of insulin, blood lipid panel, glucose, testosterone, estrogen, insulin-like growth factor-I, creatine kinase, total testosterone, free testosterone and dihydrotestosterone (DHT) on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-ingredient Supplement for Strength and Power
Official Title  ICMJE The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes
Brief Summary

It has been suggested that high amounts of total serum testosterone levels correlate with higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These suggestions drive athletes and body builders to find ways to raise their testosterone levels. Many athletes and bodybuilders look to alternative methods to anabolic steroids in order increase their testosterone levels without legal repercussions or physiological side effects. Herbs and other plant extracts have been introduced as a possible source to naturally boost testosterone levels. Research supporting the use of herbs and plant extracts has been shown to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack root may naturally boost testosterone levels.

Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost testosterone and lower estrogen levels and subsequently improve performance. This product is a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic workouts, such as high intensity weight training.

T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta- alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.

The active ingredients purported to boost plasma testosterone levels are mucuna pruriens, longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve exercise performance.

It is hypothesized that there will not be any physiological changes after supplementation of T+. It is also hypothesized that performance will not be affected by the supplementation of T+.

Detailed Description The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Supplement
Intervention  ICMJE
  • Other: T+ Supplement
    Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days).
  • Other: Placebo
    The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.
Study Arms  ICMJE
  • Active Comparator: T+ Supplement
    This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
    Intervention: Other: T+ Supplement
  • Placebo Comparator: Placebo
    This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
    Intervention: Other: Placebo
Publications * Kreipke VC, Allman BR, Kinsey AW, Moffatt RJ, Hickner RC, Ormsbee MJ. Impact of Four Weeks of a Multi-Ingredient Performance Supplement on Muscular Strength, Body Composition, and Anabolic Hormones in Resistance-Trained Young Men. J Strength Cond Res. 2015 Dec;29(12):3453-65. doi: 10.1519/JSC.0000000000000995.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2015)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2013)
30
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be familiar with the three main powerlifting movements (squat, bench and deadlift)
  • Must have one month training with a designated strength coach to understand the expectations of the strength coach and movement patterns for performance
  • Have no pre-existing musculoskeletal disorders
  • Participate in the three-week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)

Exclusion Criteria:

  • Female
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01971723
Other Study ID Numbers  ICMJE HSC#: 2013.10364
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Florida State University
Study Sponsor  ICMJE Florida State University
Collaborators  ICMJE East Carolina University
Investigators  ICMJE
Principal Investigator: Michael J Ormsbee, PhD Florida State University
PRS Account Florida State University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP