ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Supplement
Interventions Other: T+ Supplement
Other: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description

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).

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.

Period Title: Overall Study
Started 16 16
Completed 14 13
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             1
Protocol Violation             1             2
Arm/Group Title T+ Supplement Placebo Total
Hide Arm/Group Description

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).

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.

Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
13
 100.0%
27
 100.0%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 14 participants 13 participants 27 participants
179.13  (5.57) 177.64  (4.78) 178.39  (4.51)
Body Mass (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 14 participants 13 participants 27 participants
75.89  (10.43) 79.24  (9.71) 77.43  (9.85)
BMI(kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14 participants 13 participants 27 participants
24.73  (2.45) 25.43  (3.15) 25.06  (2.90)
Total Strength (kg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 14 participants 13 participants 27 participants
379  (58.61) 375.87  (70.07) 375.87  (61.97)
[1]
Measure Description: Total strength was calculated by the summation of all one-repetition maxes (squat + bench + deadlift
1.Primary Outcome
Title Strength Performance Outcomes
Hide Description

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.

Time Frame Baseline measures and 4 weeks from start of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: Kg
Baseline Squat 119.48  (24.84) 120.45  (29.82)
Post Training Squat 132.47  (26.72) 129.37  (28.98)
Baseline Bench 102.27  (15.75) 96.33  (22.01)
Post Training Bench 108.44  (16.30) 100.87  (21.69)
Baseline Deadlift 157.79  (23.05) 169.93  (30.07)
Post Training Deadlift 171.59  (22.42) 169.93  (30.07)
Baseline Total 379  (58.61) 375.87  (70.07)
Post Training Total 412.5  (60.17) 400.17  (75.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for the squat one repetition maximum outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .38
Comments [Not Specified]
Method ANOVA
Comments Groups were compared against each other at the two different time points and against themselves at the same time points.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for the bench press one repetition maximum outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for the deadlift one repetition maximum measures, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis compares the outcomes of the total weight lifted.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Insulin Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ulU/ml
Baseline Levels 5.70  (3.42) 5.83  (2.73)
Mid Training Levels 5.68  (4.51) 5.34  (2.39)
Post Training Levels 5.52  (2.3) 6.51  (2.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Blood Lipid Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: mg/dl
Cholesterol Baseline 158  (28) 162  (31)
Cholesterol Mid Training 161  (26) 160  (29)
Cholesterol Post Training 162  (27) 161  (26)
Glucose Baseline 93  (11) 98  (12)
Glucose Mid Training 96  (6) 94  (14)
Glucose Post Training 97  (9) 96  (11)
HDL Basline 47  (8) 50  (8)
HDL Mid Training 47  (8) 50  (9)
HDL Post Training 47  (7) 53  (9)
LDL Basline 91  (20) 91  (27)
LDL Mid Training 90  (22) 86  (21)
LDL Post Training 89  (20) 86  (19)
Triglycerides Basline 102  (51) 88  (38)
Triglycerides Mid Training 111  (34) 94  (37)
Triglycerides Post Training 122  (51) 99  (45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical measurement is for cholesterol measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for glucose measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for HDL measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for LDL measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis for the triglyceride measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Total Testosterone Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
Pre Training Levels 564  (146) 473  (129)
Mid Training Levels 525  (116) 415  (90)
Post Training Levels 548  (148) 475  (129)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Estrogen Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: pg/ml
Pre Training Levels 32.7  (16.6) 31.9  (13.4)
Mid Training Levels 33.2  (12.7) 35.1  (16.1)
Post Training Levels 37.4  (12.2) 35.5  (11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Insulin-like Growth Factor-I Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
Pre Training Levels 166  (69) 213  (74)
Mid Training Levels 157  (59) 207  (67)
Post Training Levels 163  (54) 237  (105)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Primary Outcome
Title Bio-availableTestosterone Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
Pre Training Levels 321  (105) 282  (93)
Mid Training Levels 286  (91) 234  (53)
Post Training Levels 313  (117) 273  (90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Primary Outcome
Title Free Testosterone Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
Pre Training Levels 13.7  (4.5) 12.0  (3.9)
Mid Training Levels 12.2  (3.9) 10.0  (2.3)
Post Training Levels 13.4  (5.0) 11.6  (3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Primary Outcome
Title Dihydrotestosterone Outcomes
Hide Description 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.
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
Pre Training Levels 901  (267) 919  (424)
Mid Training Levels 690  (226) 939  (405)
Post Training Levels 926  (427) 952  (341)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Primary Outcome
Title Cortisol Outcomes
Hide Description [Not Specified]
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: ug/dl
Pre Training Levels 17.0  (4.1) 20.1  (4.0)
Mid Training Levels 17.7  (4.4) 19.9  (3.9)
Post Training Levels 19.3  (3.1) 19.2  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Primary Outcome
Title Sex-hormone Binding Globulin Outcomes
Hide Description [Not Specified]
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: nmol/l
Pre Training Levels 28.2  (12.3) 23.5  (10.4)
Mid Training Levels 32.0  (14.4) 25.5  (11.0)
Post Training Levels 30.3  (13.8) 26  (11.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Primary Outcome
Title Creatine-Kinase Outcomes
Hide Description [Not Specified]
Time Frame Baseline, 2-week mark, 4-week mark
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: mkat/L
Pre Training Levels 2.0  (1.0) 2.2  (2.4)
Mid Training Levels 2.5  (1.7) 1.7  (0.9)
Post Training Levels 1.8  (1.2) 1.8  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Volume Performance Outcomes
Hide Description 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.
Time Frame 4 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description:

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).

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: Repetitions
Deadlift 32.2  (7.7) 29.9  (8.1)
Auxiliary Squat 33.1  (2.5) 31.5  (4.9)
Squat 28  (5.7) 26  (5.8)
Bench 27.4  (6.7) 26.2  (5.5)
Total Squat 30.6  (5.1) 28.8  (6.0)
Total Weight Lifted 30.2  (6.5) 28.4  (6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for deadlift volume measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for auxiliary squat volume measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for squat volume measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for bench volume measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for total squat volume measures, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection T+ Supplement, Placebo
Comments This statistical analysis is for total weight lifted volume measure outcomes, only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Reports were only collected during the 4 weeks of training.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T+ Supplement Placebo
Hide Arm/Group Description

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).

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.

All-Cause Mortality
T+ Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
T+ Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T+ Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      0/13 (0.00%)    
Reproductive system and breast disorders     
Increased Libido * [1]  2/14 (14.29%)  2 0/13 (0.00%) 
Skin and subcutaneous tissue disorders     
paresthesia * [2]  1/14 (7.14%)  1 0/13 (0.00%)  0
Acne * [3]  2/14 (14.29%)  2 0/13 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subjects reported increased libidos
[2]
Tingling of the skin
[3]
Subjects reported more acne than usual
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michael J. Ormsbee
Organization: Florida State University
Phone: (850) 644-4793
Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01971723     History of Changes
Other Study ID Numbers: HSC#: 2013.10364
First Submitted: August 27, 2013
First Posted: October 29, 2013
Results First Submitted: January 5, 2015
Results First Posted: March 13, 2015
Last Update Posted: February 29, 2016