Multi-ingredient Supplement for Strength and Power

Not Applicable

Completed

Conditions: Supplement

Interventions: Other: T+ Supplement
Other: Placebo

Registration Number: NCT01971723

Lead Sponsor: 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+.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 32

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T+ Supplement	T+ Supplement	This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
Placebo	Placebo	This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.

Primary Outcome Measures

Name	Time	Method
Insulin Outcomes	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.
Strength Performance Outcomes	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.
Estrogen Outcomes	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	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.
Creatine-Kinase Outcomes	Baseline, 2-week mark, 4-week mark
Total Testosterone Outcomes	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.
Bio-availableTestosterone Outcomes	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	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.
Cortisol Outcomes	Baseline, 2-week mark, 4-week mark
Sex-hormone Binding Globulin Outcomes	Baseline, 2-week mark, 4-week mark
Blood Lipid Outcomes	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.
Dihydrotestosterone Outcomes	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.

Secondary Outcome Measures

Name	Time	Method
Volume Performance Outcomes	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.