Overview

This trial is active, not recruiting.

Condition supplement
Treatments t+ supplement, placebo
Sponsor Florida State University
Collaborator East Carolina University
Start date June 2013
End date September 2014
Trial size 30 participants
Trial identifier NCT01971723, HSC#: 2013.10364

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+.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Active Comparator)
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 Comparator)
This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
placebo
The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.

Primary Outcomes

Measure
Strength Performance outcomes
time frame: 4 weeks from start of study
Insulin Outcomes
time frame: At the 2-week and 4-week marks
Blood Lipid Outcomes
time frame: At the 2-week and 4-week marks
Glucose Outcomes
time frame: At the 2-week and 4-week marks
Testosterone Outcomes
time frame: At the 2-week and 4-week marks
Estrogen Outcomes
time frame: At the 2-week and 4-week marks
Insulin-like Growth Factor-I Outcomes
time frame: At the 2-week and 4-week marks
Total Testosterone Outcomes
time frame: At the 2-week and 4-week marks
Free Testosterone Outcomes
time frame: At the 2-week and 4-week marks
dihydrotestosterone Outcomes
time frame: At the 2-week and 4-week marks

Secondary Outcomes

Measure
Volume Performance
time frame: 4 Weeks

Eligibility Criteria

Male participants from 18 years up to 35 years old.

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

Additional Information

Official title The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes
Principal investigator Michael J Ormsbee, PhD
Description The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Florida State University.