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CompletedNCT01971723Updated Feb 29, 2016Results posted

Multi-ingredient Supplement for Strength and Power

An interventional study of T+ Supplement and Placebo in Supplement, sponsored by Florida State University. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by Florida State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study summary

It has been suggested that high amounts of total serum testosterone levels correlate with higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These suggestions drive athletes and body builders to find ways to raise their testosterone levels. Many athletes and bodybuilders look to alternative methods to anabolic steroids in order increase their testosterone levels without legal repercussions or physiological side effects. Herbs and other plant extracts have been introduced as a possible source to naturally boost testosterone levels. Research supporting the use of herbs and plant extracts has been shown to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack root may naturally boost testosterone levels.

Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost testosterone and lower estrogen levels and subsequently improve performance. This product is a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic workouts, such as high intensity weight training.

T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta- alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.

The active ingredients purported to boost plasma testosterone levels are mucuna pruriens, longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve exercise performance.

It is hypothesized that there will not be any physiological changes after supplementation of T+. It is also hypothesized that performance will not be affected by the supplementation of T+.

Read the detailed description

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

02

Conditions studied

  • Supplement

Keywords

  • Testosterone
  • Estrogen
  • Insulin
  • Blood Lipid
  • Glucose
  • Creatine Kinase
  • Strength
  • Power Athlete
03

In context

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be familiar with the three main powerlifting movements (squat, bench and deadlift)
  • Must have one month training with a designated strength coach to understand the expectations of the strength coach and movement patterns for performance
  • Have no pre-existing musculoskeletal disorders
  • Participate in the three-week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)

Exclusion criteria

Exclusion Criteria:

  • Female
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    T+ Supplement

    This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.

    Other: T+ Supplement

  • Placebo comparator
    Placebo

    This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.

    Other: Placebo

Interventions

  • OtherT+ 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).

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline measures and 4 weeks from start of study

  2. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  3. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  4. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  5. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  6. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  7. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  8. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  9. 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.

    Time frame: Baseline, 2-week mark, 4-week mark

  10. Cortisol Outcomes

    Time frame: Baseline, 2-week mark, 4-week mark

  11. Sex-hormone Binding Globulin Outcomes

    Time frame: Baseline, 2-week mark, 4-week mark

  12. Creatine-Kinase Outcomes

    Time frame: Baseline, 2-week mark, 4-week mark

Secondary outcomes

  1. 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.

    Time frame: 4 Weeks

07

Results

Posted Mar 13, 2015
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneT+ SupplementPlacebo
Started1616
Completed1413
Not completed23
Withdrew: Withdrawal by subject11
Withdrew: Protocol violation12

Outcome measures

PrimaryStrength 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.

Time frame:
Baseline measures and 4 weeks from start of study
Reported as:
Mean · Kg
Strength Performance Outcomes
KgT+ SupplementPlacebo
Baseline Squat119.48 ± 24.84120.45 ± 29.82
Post Training Squat132.47 ± 26.72129.37 ± 28.98
Baseline Bench102.27 ± 15.7596.33 ± 22.01
Post Training Bench108.44 ± 16.30100.87 ± 21.69
Baseline Deadlift157.79 ± 23.05169.93 ± 30.07
Post Training Deadlift171.59 ± 22.42169.93 ± 30.07
Baseline Total379 ± 58.61375.87 ± 70.07
Post Training Total412.5 ± 60.17400.17 ± 75.03
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = .38Groups were compared against each other at the two different time points and against themselves at the same time points.
  • T+ Supplement vs Placebo · ANOVA · p = 0.0001
  • T+ Supplement vs Placebo · ANOVA · p = .3
  • T+ Supplement vs Placebo · ANOVA · p = 0.0001
PrimaryInsulin 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ulU/ml
Insulin Outcomes
ulU/mlT+ SupplementPlacebo
Baseline Levels5.70 ± 3.425.83 ± 2.73
Mid Training Levels5.68 ± 4.515.34 ± 2.39
Post Training Levels5.52 ± 2.36.51 ± 2.67
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryBlood 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · mg/dl
Blood Lipid Outcomes
mg/dlT+ SupplementPlacebo
Cholesterol Baseline158 ± 28162 ± 31
Cholesterol Mid Training161 ± 26160 ± 29
Cholesterol Post Training162 ± 27161 ± 26
Glucose Baseline93 ± 1198 ± 12
Glucose Mid Training96 ± 694 ± 14
Glucose Post Training97 ± 996 ± 11
HDL Basline47 ± 850 ± 8
HDL Mid Training47 ± 850 ± 9
HDL Post Training47 ± 753 ± 9
LDL Basline91 ± 2091 ± 27
LDL Mid Training90 ± 2286 ± 21
LDL Post Training89 ± 2086 ± 19
Triglycerides Basline102 ± 5188 ± 38
Triglycerides Mid Training111 ± 3494 ± 37
Triglycerides Post Training122 ± 5199 ± 45
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
  • T+ Supplement vs Placebo · ANOVA · p = >.05
  • T+ Supplement vs Placebo · ANOVA · p = >.05
  • T+ Supplement vs Placebo · ANOVA · p = >.05
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryTotal 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ng/dL
Total Testosterone Outcomes
ng/dLT+ SupplementPlacebo
Pre Training Levels564 ± 146473 ± 129
Mid Training Levels525 ± 116415 ± 90
Post Training Levels548 ± 148475 ± 129
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryEstrogen 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · pg/ml
Estrogen Outcomes
pg/mlT+ SupplementPlacebo
Pre Training Levels32.7 ± 16.631.9 ± 13.4
Mid Training Levels33.2 ± 12.735.1 ± 16.1
Post Training Levels37.4 ± 12.235.5 ± 11.3
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryInsulin-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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ng/dL
Insulin-like Growth Factor-I Outcomes
ng/dLT+ SupplementPlacebo
Pre Training Levels166 ± 69213 ± 74
Mid Training Levels157 ± 59207 ± 67
Post Training Levels163 ± 54237 ± 105
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryBio-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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ng/dL
Bio-availableTestosterone Outcomes
ng/dLT+ SupplementPlacebo
Pre Training Levels321 ± 105282 ± 93
Mid Training Levels286 ± 91234 ± 53
Post Training Levels313 ± 117273 ± 90
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryFree 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ng/dL
Free Testosterone Outcomes
ng/dLT+ SupplementPlacebo
Pre Training Levels13.7 ± 4.512.0 ± 3.9
Mid Training Levels12.2 ± 3.910.0 ± 2.3
Post Training Levels13.4 ± 5.011.6 ± 3.8
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryDihydrotestosterone 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.

Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ng/dL
Dihydrotestosterone Outcomes
ng/dLT+ SupplementPlacebo
Pre Training Levels901 ± 267919 ± 424
Mid Training Levels690 ± 226939 ± 405
Post Training Levels926 ± 427952 ± 341
Statistical analysis
  • T+ Supplement vs Placebo · Chi-squared · p = >.05
SecondaryVolume 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.

Time frame:
4 Weeks
Reported as:
Mean · Repetitions
Volume Performance Outcomes
RepetitionsT+ SupplementPlacebo
Deadlift32.2 ± 7.729.9 ± 8.1
Auxiliary Squat33.1 ± 2.531.5 ± 4.9
Squat28 ± 5.726 ± 5.8
Bench27.4 ± 6.726.2 ± 5.5
Total Squat30.6 ± 5.128.8 ± 6.0
Total Weight Lifted30.2 ± 6.528.4 ± 6.6
Statistical analysis
  • T+ Supplement vs Placebo · t-test, 2 sided · p = >.05
  • T+ Supplement vs Placebo · t-test, 2 sided · p = >.05
  • T+ Supplement vs Placebo · ANOVA · p = >.05
  • T+ Supplement vs Placebo · t-test, 2 sided · p = >.05
  • T+ Supplement vs Placebo · t-test, 2 sided · p = >.05
  • T+ Supplement vs Placebo · t-test, 2 sided · p = >.05
PrimaryCortisol Outcomes
Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · ug/dl
Cortisol Outcomes
ug/dlT+ SupplementPlacebo
Pre Training Levels17.0 ± 4.120.1 ± 4.0
Mid Training Levels17.7 ± 4.419.9 ± 3.9
Post Training Levels19.3 ± 3.119.2 ± 3.0
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimarySex-hormone Binding Globulin Outcomes
Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · nmol/l
Sex-hormone Binding Globulin Outcomes
nmol/lT+ SupplementPlacebo
Pre Training Levels28.2 ± 12.323.5 ± 10.4
Mid Training Levels32.0 ± 14.425.5 ± 11.0
Post Training Levels30.3 ± 13.826 ± 11.6
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = >.05
PrimaryCreatine-Kinase Outcomes
Time frame:
Baseline, 2-week mark, 4-week mark
Reported as:
Mean · mkat/L
Creatine-Kinase Outcomes
mkat/LT+ SupplementPlacebo
Pre Training Levels2.0 ± 1.02.2 ± 2.4
Mid Training Levels2.5 ± 1.71.7 ± 0.9
Post Training Levels1.8 ± 1.21.8 ± 1.7
Statistical analysis
  • T+ Supplement vs Placebo · ANOVA · p = .05

Adverse events

Collected over Reports were only collected during the 4 weeks of training.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
T+ Supplement—0/14 (0%)5/14 (35.7%)
Placebo—0/13 (0%)0/13 (0%)
Most frequent other events
Most frequent other events
EventT+ SupplementPlacebo
Increased LibidoReproductive system and breast disorders2/140/13
AcneSkin and subcutaneous tissue disorders2/140/13
paresthesiaSkin and subcutaneous tissue disorders1/140/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)T+ SupplementPlaceboTotal
<=18 years000
Between 18 and 65 years141327
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)T+ SupplementPlaceboTotal
Female000
Male141327
Height (cm)
Height (cm)(cm)T+ SupplementPlaceboTotal
Mean179.13 ± 5.57177.64 ± 4.78178.39 ± 4.51
Body Mass (kg)
Body Mass (kg)(kg)T+ SupplementPlaceboTotal
Mean75.89 ± 10.4379.24 ± 9.7177.43 ± 9.85
BMI(kg/m^2)
BMI(kg/m^2)(kg/m^2)T+ SupplementPlaceboTotal
Mean24.73 ± 2.4525.43 ± 3.1525.06 ± 2.90
Total Strength (kg)
Total Strength (kg)(kg)T+ SupplementPlaceboTotal
Mean379 ± 58.61375.87 ± 70.07375.87 ± 61.97
08

Study locations

1 site
  • Florida State University
    Tallahassee, Florida 32306, United States
09

References and documents

Publications

  • 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. PubMed 26595135 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01971723
Lead sponsor
Florida State University
Collaborators
East Carolina University
Responsible party
Sponsor
First posted
Oct 29, 2013
Start date
Jun 2013
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Mar 13, 2015
Last update
Feb 29, 2016

Study contacts

Michael J Ormsbee, PhD
principal investigator · Florida State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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