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| Name | Class |
|---|---|
| East Carolina University | OTHER |
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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+.
The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T+ Supplement | Active Comparator | This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment. |
|
| Placebo | Placebo Comparator | This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T+ Supplement | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Ormsbee, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26595135 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | T+ Supplement | This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment. 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). |
| FG001 | Placebo | This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T+ Supplement | This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Kg | Baseline measures and 4 weeks from start of study |
|
Reports were only collected during the 4 weeks of training.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T+ Supplement | This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment. 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Libido | Reproductive system and breast disorders | Non-systematic Assessment | Subjects reported increased libidos |
Unable to standardize individual ingredients in T+ supplement. Volume of lifts not tested was not analyzed for statistical significance. Neuromuscular adaptations were not tested. Length of study may have affected body composition measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael J. Ormsbee | Florida State University | (850) 644-4793 | mormsbee@fsu.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | 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. |
|
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 |
| BG001 | Placebo | This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Body Mass (kg) | Mean | Standard Deviation | kg |
|
| BMI(kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Total Strength (kg) | Total strength was calculated by the summation of all one-repetition maxes (squat + bench + deadlift | Mean | Standard Deviation | kg |
|
| OG001 | Placebo | This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. 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 | 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. | Posted | Mean | Standard Deviation | ulU/ml | Baseline, 2-week mark, 4-week mark |
|
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | mg/dl | Baseline, 2-week mark, 4-week mark |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, 2-week mark, 4-week mark |
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| Primary | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, 2-week mark, 4-week mark |
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, 2-week mark, 4-week mark |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, 2-week mark, 4-week mark |
|
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, 2-week mark, 4-week mark |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, 2-week mark, 4-week mark |
|
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Repetitions | 4 Weeks |
|
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| Primary | Cortisol Outcomes | Posted | Mean | Standard Deviation | ug/dl | Baseline, 2-week mark, 4-week mark |
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| Primary | Sex-hormone Binding Globulin Outcomes | Posted | Mean | Standard Deviation | nmol/l | Baseline, 2-week mark, 4-week mark |
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| Primary | Creatine-Kinase Outcomes | Posted | Mean | Standard Deviation | mkat/L | Baseline, 2-week mark, 4-week mark |
|
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| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | Placebo | This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. 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. | 0 | 13 | 0 | 13 |
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| paresthesia | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Tingling of the skin |
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| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subjects reported more acne than usual |
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| Post Training Levels |
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| Cholesterol Post Training |
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| Glucose Baseline |
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| Glucose Mid Training |
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| Glucose Post Training |
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| HDL Basline |
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| HDL Mid Training |
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| HDL Post Training |
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| LDL Basline |
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| LDL Mid Training |
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| LDL Post Training |
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| Triglycerides Basline |
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| Triglycerides Mid Training |
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| Triglycerides Post Training |
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| ANOVA |
| >.05 |
| 2-Sided |
| No |
| Superiority or Other |
| This statistical analysis is for HDL measure outcomes, only. | ANOVA | >.05 | 2-Sided | No | Superiority or Other |
| This statistical analysis is for LDL measure outcomes, only. | ANOVA | >.05 | 2-Sided | No | Superiority or Other |
| This statistical analysis for the triglyceride measure outcomes, only. | ANOVA | >.05 | 2-Sided | No | Superiority or Other |
| Post Training Levels |
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| Post Training Levels |
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| Post Training Levels |
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| Post Training Levels |
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| Post Training Levels |
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| Post Training Levels |
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| Squat |
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| Bench |
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| Total Squat |
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| Total Weight Lifted |
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| t-test, 2 sided |
| >.05 |
| 2-Sided |
| No |
| Superiority or Other |
| This statistical analysis is for squat volume measure outcomes, only. | ANOVA | >.05 | 2-Sided | No | Superiority or Other |
| This statistical analysis is for bench volume measure outcomes, only. | t-test, 2 sided | >.05 | 2-Sided | No | Superiority or Other |
| This statistical analysis is for total squat volume measures, only. | t-test, 2 sided | >.05 | 2-Sided | No | Superiority or Other |
| This statistical analysis is for total weight lifted volume measure outcomes, only. | t-test, 2 sided | >.05 | 2-Sided | No | Superiority or Other |
| Post Training Levels |
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| Post Training Levels |
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| Post Training Levels |
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