Multi-ingredient Supplement for Strength and Power

NCT01971723 | Completed Results

• 1 other identifier: HSC#: 2013.10364
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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+.

Conditions

Supplement

Keywords

Testosterone; Estrogen; Insulin; Blood Lipid; Glucose; Creatine Kinase; Strength; Power Athlete

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• Volume Performance Outcomes

  4 Weeks

Study Arms (2)

T+ Supplement

ACTIVE COMPARATOR

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

Placebo

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.

Other: Placebo

Interventions

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).

T+ Supplement

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Female

Sponsors & Collaborators

• Florida State University: lead
• East Carolina University: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• 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.

  PMID: 26595135 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Unable to standardize individual ingredients in T+ supplement. Volume of lifts not tested was not analyzed for statistical significance. Neuromuscular adaptations were not tested. Length of study may have affected body composition measures.

Results Point of Contact

• Title: Dr. Michael J. Ormsbee
• Organization: Florida State University

mormsbee@fsu.edu

(850) 644-4793

Study Officials

• Michael J Ormsbee, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: October 29, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 29, 2016
• Results First Posted: March 13, 2015

Record last verified: 2016-02

Locations

US (1)