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Multi-ingredient Supplement for Strength and Power

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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+.


Condition or disease Intervention/treatment Phase
Supplement Other: T+ Supplement Other: Placebo Not Applicable

Detailed Description:
The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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).

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.
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.




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Cortisol Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
  11. Sex-hormone Binding Globulin Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]
  12. Creatine-Kinase Outcomes [ Time Frame: Baseline, 2-week mark, 4-week mark ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971723


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
East Carolina University
Investigators
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Principal Investigator: Michael J Ormsbee, PhD Florida State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01971723    
Other Study ID Numbers: HSC#: 2013.10364
First Posted: October 29, 2013    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: February 29, 2016
Last Verified: February 2016
Keywords provided by Florida State University:
Testosterone
Estrogen
Insulin
Blood Lipid
Glucose
Creatine Kinase
Strength
Power Athlete