Multi-ingredient Supplement for Strength and Power

Supplement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971723
• Other study ID #: HSC#: 2013.10364
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: February 1, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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+.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Supplement

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline measures and 4 weeks from start of study	No
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	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.	Baseline, 2-week mark, 4-week mark	Yes
Primary	Cortisol Outcomes		Baseline, 2-week mark, 4-week mark	Yes
Primary	Sex-hormone Binding Globulin Outcomes		Baseline, 2-week mark, 4-week mark	No
Primary	Creatine-Kinase Outcomes		Baseline, 2-week mark, 4-week mark	Yes
Secondary	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.	4 Weeks	No