Multi-ingredient Supplement for Strength and Power

Study Overview
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Brief Summary
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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
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The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.

Official Title
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The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes

Conditions
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Supplement

Intervention / Treatment
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* Other: T+ Supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T+ Supplement<br>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<br>* 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).<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength Performance Outcomes | 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. | Baseline measures and 4 weeks from start of study | 
| Insulin Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Blood Lipid Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Total Testosterone Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Estrogen Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Insulin-like Growth Factor-I Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Bio-availableTestosterone Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Free Testosterone Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Dihydrotestosterone Outcomes | 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. | Baseline, 2-week mark, 4-week mark | 
| Cortisol Outcomes |  | Baseline, 2-week mark, 4-week mark | 
| Sex-hormone Binding Globulin Outcomes |  | Baseline, 2-week mark, 4-week mark | 
| Creatine-Kinase Outcomes |  | Baseline, 2-week mark, 4-week mark | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume Performance Outcomes | 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. | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Estrogen, Insulin, Blood Lipid, Glucose, Creatine Kinase, Strength, Power Athlete