Multi-ingredient Supplement for Strength and Power

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

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+.

Study Overview

• Status: Completed
• Conditions: Supplement
• Intervention / Treatment: Other: T+ Supplement; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Cortisol Outcomes		Baseline, 2-week mark, 4-week mark
Sex-hormone Binding Globulin Outcomes		Baseline, 2-week mark, 4-week mark
Creatine-Kinase Outcomes		Baseline, 2-week mark, 4-week mark

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: East Carolina University
• Investigators: Principal Investigator: Michael J Ormsbee, PhD, Florida State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Insulin; Glucose; Strength; Testosterone; Estrogen; Creatine Kinase; Blood Lipid; Power Athlete
• Other Study ID Numbers: HSC#: 2013.10364