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Completed

NCT Number: NCT01971723

Multi-ingredient Supplement for Strength and Power

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+.

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Key information

Conditions

Supplement Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Female

Treatment and study plan

T+ Supplement

Other

Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days).

Placebo

Other

The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.

Primary outcomes

  1. Strength Performance Outcomes

    Time frame: 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.

  2. Insulin Outcomes

    Time frame: 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.

  3. Blood Lipid Outcomes

    Time frame: 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.

  4. Total Testosterone Outcomes

    Time frame: 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.

  5. Estrogen Outcomes

    Time frame: 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.

  6. Insulin-like Growth Factor-I Outcomes

    Time frame: 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.

  7. Bio-availableTestosterone Outcomes

    Time frame: 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.

  8. Free Testosterone Outcomes

    Time frame: 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.

  9. Dihydrotestosterone Outcomes

    Time frame: 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.

  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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • East Carolina University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2013
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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