Clinical trial NCT01971723: Multi-ingredient Supplement for Strength and Power
Official title: The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplement
Keywords: Testosterone
Estrogen
Insulin
Blood Lipid
Glucose
Creatine Kinase
Strength
Power Athlete
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: East Carolina University
First posted: 2013-10-29
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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+.

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

Eligibility criteria: 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

Primary outcomes:
measure: Strength Performance Outcomes
timeFrame: Baseline measures and 4 weeks from start of study
measure: Insulin Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Blood Lipid Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Total Testosterone Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Estrogen Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Insulin-like Growth Factor-I Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Bio-availableTestosterone Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Free Testosterone Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Dihydrotestosterone Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Cortisol Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Sex-hormone Binding Globulin Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
measure: Creatine-Kinase Outcomes
timeFrame: Baseline, 2-week mark, 4-week mark
Secondary outcomes:
measure: Volume Performance Outcomes
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Michael J Ormsbee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.