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Multi-ingredient Supplement for Strength and Power

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ClinicalTrials.gov Identifier: NCT01971723
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : March 13, 2015
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
East Carolina University
Information provided by (Responsible Party):
Florida State University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Supplement
Interventions: Other: T+ Supplement
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
T+ Supplement

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

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.


Participant Flow:   Overall Study
    T+ Supplement   Placebo
STARTED   16   16 
COMPLETED   14   13 
NOT COMPLETED   2   3 
Withdrawal by Subject                1                1 
Protocol Violation                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
T+ Supplement

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

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.

Total Total of all reporting groups

Baseline Measures
   T+ Supplement   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   13   27 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   14   13   27 
Height (cm) 
[Units: Cm]
Mean (Standard Deviation)
 179.13  (5.57)   177.64  (4.78)   178.39  (4.51) 
Body Mass (kg) 
[Units: Kg]
Mean (Standard Deviation)
 75.89  (10.43)   79.24  (9.71)   77.43  (9.85) 
BMI(kg/m^2) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.73  (2.45)   25.43  (3.15)   25.06  (2.90) 
Total Strength (kg) [1] 
[Units: Kg]
Mean (Standard Deviation)
 379  (58.61)   375.87  (70.07)   375.87  (61.97) 
[1] Total strength was calculated by the summation of all one-repetition maxes (squat + bench + deadlift


  Outcome Measures

1.  Primary:   Strength Performance Outcomes   [ Time Frame: Baseline measures and 4 weeks from start of study ]

2.  Primary:   Insulin Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

3.  Primary:   Blood Lipid Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

4.  Primary:   Total Testosterone Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

5.  Primary:   Estrogen Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

6.  Primary:   Insulin-like Growth Factor-I Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

7.  Primary:   Bio-availableTestosterone Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

8.  Primary:   Free Testosterone Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

9.  Primary:   Dihydrotestosterone Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

10.  Primary:   Cortisol Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

11.  Primary:   Sex-hormone Binding Globulin Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

12.  Primary:   Creatine-Kinase Outcomes   [ Time Frame: Baseline, 2-week mark, 4-week mark ]

13.  Secondary:   Volume Performance Outcomes   [ Time Frame: 4 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Michael J. Ormsbee
Organization: Florida State University
phone: (850) 644-4793
e-mail: mormsbee@fsu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01971723     History of Changes
Other Study ID Numbers: HSC#: 2013.10364
First Submitted: August 27, 2013
First Posted: October 29, 2013
Results First Submitted: January 5, 2015
Results First Posted: March 13, 2015
Last Update Posted: February 29, 2016