Trial Outcomes & Findings for Multi-ingredient Supplement for Strength and Power (NCT NCT01971723)

NCT ID: NCT01971723

Last Updated: 2016-02-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Baseline measures and 4 weeks from start of study
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	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).	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.
Overall Study STARTED	16	16
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	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).	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.
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	1	2

Baseline Characteristics

Multi-ingredient Supplement for Strength and Power

Baseline characteristics by cohort

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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 n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Height (cm)	179.13 cm STANDARD_DEVIATION 5.57 • n=5 Participants	177.64 cm STANDARD_DEVIATION 4.78 • n=7 Participants	178.39 cm STANDARD_DEVIATION 4.51 • n=5 Participants
Body Mass (kg)	75.89 kg STANDARD_DEVIATION 10.43 • n=5 Participants	79.24 kg STANDARD_DEVIATION 9.71 • n=7 Participants	77.43 kg STANDARD_DEVIATION 9.85 • n=5 Participants
BMI(kg/m^2)	24.73 kg/m^2 STANDARD_DEVIATION 2.45 • n=5 Participants	25.43 kg/m^2 STANDARD_DEVIATION 3.15 • n=7 Participants	25.06 kg/m^2 STANDARD_DEVIATION 2.90 • n=5 Participants
Total Strength (kg)	379 kg STANDARD_DEVIATION 58.61 • n=5 Participants	375.87 kg STANDARD_DEVIATION 70.07 • n=7 Participants	375.87 kg STANDARD_DEVIATION 61.97 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Strength Performance Outcomes Baseline Squat	119.48 Kg Standard Deviation 24.84	120.45 Kg Standard Deviation 29.82
Strength Performance Outcomes Post Training Squat	132.47 Kg Standard Deviation 26.72	129.37 Kg Standard Deviation 28.98
Strength Performance Outcomes Baseline Bench	102.27 Kg Standard Deviation 15.75	96.33 Kg Standard Deviation 22.01
Strength Performance Outcomes Post Training Bench	108.44 Kg Standard Deviation 16.30	100.87 Kg Standard Deviation 21.69
Strength Performance Outcomes Baseline Deadlift	157.79 Kg Standard Deviation 23.05	169.93 Kg Standard Deviation 30.07
Strength Performance Outcomes Post Training Deadlift	171.59 Kg Standard Deviation 22.42	169.93 Kg Standard Deviation 30.07
Strength Performance Outcomes Baseline Total	379 Kg Standard Deviation 58.61	375.87 Kg Standard Deviation 70.07
Strength Performance Outcomes Post Training Total	412.5 Kg Standard Deviation 60.17	400.17 Kg Standard Deviation 75.03

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Insulin Outcomes Baseline Levels	5.70 ulU/ml Standard Deviation 3.42	5.83 ulU/ml Standard Deviation 2.73
Insulin Outcomes Mid Training Levels	5.68 ulU/ml Standard Deviation 4.51	5.34 ulU/ml Standard Deviation 2.39
Insulin Outcomes Post Training Levels	5.52 ulU/ml Standard Deviation 2.3	6.51 ulU/ml Standard Deviation 2.67

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Blood Lipid Outcomes Cholesterol Baseline	158 mg/dl Standard Deviation 28	162 mg/dl Standard Deviation 31
Blood Lipid Outcomes Cholesterol Mid Training	161 mg/dl Standard Deviation 26	160 mg/dl Standard Deviation 29
Blood Lipid Outcomes Cholesterol Post Training	162 mg/dl Standard Deviation 27	161 mg/dl Standard Deviation 26
Blood Lipid Outcomes Glucose Baseline	93 mg/dl Standard Deviation 11	98 mg/dl Standard Deviation 12
Blood Lipid Outcomes Glucose Mid Training	96 mg/dl Standard Deviation 6	94 mg/dl Standard Deviation 14
Blood Lipid Outcomes Glucose Post Training	97 mg/dl Standard Deviation 9	96 mg/dl Standard Deviation 11
Blood Lipid Outcomes HDL Basline	47 mg/dl Standard Deviation 8	50 mg/dl Standard Deviation 8
Blood Lipid Outcomes HDL Mid Training	47 mg/dl Standard Deviation 8	50 mg/dl Standard Deviation 9
Blood Lipid Outcomes HDL Post Training	47 mg/dl Standard Deviation 7	53 mg/dl Standard Deviation 9
Blood Lipid Outcomes LDL Basline	91 mg/dl Standard Deviation 20	91 mg/dl Standard Deviation 27
Blood Lipid Outcomes LDL Mid Training	90 mg/dl Standard Deviation 22	86 mg/dl Standard Deviation 21
Blood Lipid Outcomes LDL Post Training	89 mg/dl Standard Deviation 20	86 mg/dl Standard Deviation 19
Blood Lipid Outcomes Triglycerides Basline	102 mg/dl Standard Deviation 51	88 mg/dl Standard Deviation 38
Blood Lipid Outcomes Triglycerides Mid Training	111 mg/dl Standard Deviation 34	94 mg/dl Standard Deviation 37
Blood Lipid Outcomes Triglycerides Post Training	122 mg/dl Standard Deviation 51	99 mg/dl Standard Deviation 45

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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 Testosterone Outcomes Pre Training Levels	564 ng/dL Standard Deviation 146	473 ng/dL Standard Deviation 129
Total Testosterone Outcomes Mid Training Levels	525 ng/dL Standard Deviation 116	415 ng/dL Standard Deviation 90
Total Testosterone Outcomes Post Training Levels	548 ng/dL Standard Deviation 148	475 ng/dL Standard Deviation 129

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Estrogen Outcomes Pre Training Levels	32.7 pg/ml Standard Deviation 16.6	31.9 pg/ml Standard Deviation 13.4
Estrogen Outcomes Mid Training Levels	33.2 pg/ml Standard Deviation 12.7	35.1 pg/ml Standard Deviation 16.1
Estrogen Outcomes Post Training Levels	37.4 pg/ml Standard Deviation 12.2	35.5 pg/ml Standard Deviation 11.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Insulin-like Growth Factor-I Outcomes Pre Training Levels	166 ng/dL Standard Deviation 69	213 ng/dL Standard Deviation 74
Insulin-like Growth Factor-I Outcomes Mid Training Levels	157 ng/dL Standard Deviation 59	207 ng/dL Standard Deviation 67
Insulin-like Growth Factor-I Outcomes Post Training Levels	163 ng/dL Standard Deviation 54	237 ng/dL Standard Deviation 105

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Bio-availableTestosterone Outcomes Pre Training Levels	321 ng/dL Standard Deviation 105	282 ng/dL Standard Deviation 93
Bio-availableTestosterone Outcomes Mid Training Levels	286 ng/dL Standard Deviation 91	234 ng/dL Standard Deviation 53
Bio-availableTestosterone Outcomes Post Training Levels	313 ng/dL Standard Deviation 117	273 ng/dL Standard Deviation 90

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Free Testosterone Outcomes Pre Training Levels	13.7 ng/dL Standard Deviation 4.5	12.0 ng/dL Standard Deviation 3.9
Free Testosterone Outcomes Mid Training Levels	12.2 ng/dL Standard Deviation 3.9	10.0 ng/dL Standard Deviation 2.3
Free Testosterone Outcomes Post Training Levels	13.4 ng/dL Standard Deviation 5.0	11.6 ng/dL Standard Deviation 3.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Dihydrotestosterone Outcomes Pre Training Levels	901 ng/dL Standard Deviation 267	919 ng/dL Standard Deviation 424
Dihydrotestosterone Outcomes Mid Training Levels	690 ng/dL Standard Deviation 226	939 ng/dL Standard Deviation 405
Dihydrotestosterone Outcomes Post Training Levels	926 ng/dL Standard Deviation 427	952 ng/dL Standard Deviation 341

PRIMARY outcome

Timeframe: Baseline, 2-week mark, 4-week mark

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Cortisol Outcomes Pre Training Levels	17.0 ug/dl Standard Deviation 4.1	20.1 ug/dl Standard Deviation 4.0
Cortisol Outcomes Mid Training Levels	17.7 ug/dl Standard Deviation 4.4	19.9 ug/dl Standard Deviation 3.9
Cortisol Outcomes Post Training Levels	19.3 ug/dl Standard Deviation 3.1	19.2 ug/dl Standard Deviation 3.0

PRIMARY outcome

Timeframe: Baseline, 2-week mark, 4-week mark

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Sex-hormone Binding Globulin Outcomes Pre Training Levels	28.2 nmol/l Standard Deviation 12.3	23.5 nmol/l Standard Deviation 10.4
Sex-hormone Binding Globulin Outcomes Mid Training Levels	32.0 nmol/l Standard Deviation 14.4	25.5 nmol/l Standard Deviation 11.0
Sex-hormone Binding Globulin Outcomes Post Training Levels	30.3 nmol/l Standard Deviation 13.8	26 nmol/l Standard Deviation 11.6

PRIMARY outcome

Timeframe: Baseline, 2-week mark, 4-week mark

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Creatine-Kinase Outcomes Pre Training Levels	2.0 mkat/L Standard Deviation 1.0	2.2 mkat/L Standard Deviation 2.4
Creatine-Kinase Outcomes Mid Training Levels	2.5 mkat/L Standard Deviation 1.7	1.7 mkat/L Standard Deviation 0.9
Creatine-Kinase Outcomes Post Training Levels	1.8 mkat/L Standard Deviation 1.2	1.8 mkat/L Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	T+ Supplement n=14 Participants 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).	Placebo n=13 Participants 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.
Volume Performance Outcomes Squat	28 Repetitions Standard Deviation 5.7	26 Repetitions Standard Deviation 5.8
Volume Performance Outcomes Deadlift	32.2 Repetitions Standard Deviation 7.7	29.9 Repetitions Standard Deviation 8.1
Volume Performance Outcomes Auxiliary Squat	33.1 Repetitions Standard Deviation 2.5	31.5 Repetitions Standard Deviation 4.9
Volume Performance Outcomes Bench	27.4 Repetitions Standard Deviation 6.7	26.2 Repetitions Standard Deviation 5.5
Volume Performance Outcomes Total Squat	30.6 Repetitions Standard Deviation 5.1	28.8 Repetitions Standard Deviation 6.0
Volume Performance Outcomes Total Weight Lifted	30.2 Repetitions Standard Deviation 6.5	28.4 Repetitions Standard Deviation 6.6

Adverse Events

T+ Supplement

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	T+ Supplement n=14 participants at risk 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).	Placebo n=13 participants at risk 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.
Reproductive system and breast disorders Increased Libido	14.3% 2/14 • Number of events 2 • Reports were only collected during the 4 weeks of training.	0.00% 0/13 • Reports were only collected during the 4 weeks of training.
Skin and subcutaneous tissue disorders paresthesia	7.1% 1/14 • Number of events 1 • Reports were only collected during the 4 weeks of training.	0.00% 0/13 • Reports were only collected during the 4 weeks of training.
Skin and subcutaneous tissue disorders Acne	14.3% 2/14 • Number of events 2 • Reports were only collected during the 4 weeks of training.	0.00% 0/13 • Reports were only collected during the 4 weeks of training.

Additional Information

Dr. Michael J. Ormsbee

Florida State University

Phone: (850) 644-4793

Email: mormsbee@fsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place