Blood Lipid Profiles, Body Composition, Hormone Profiles, Performance Measures
Conditions
Keywords
Multi-ingredient performance supplement, High Intensity Interval Training, Concurrent training
Brief summary
This study will examine how the supplement Shroom Tech Sport (STS) affects body composition and different performance and health measures over the course of 12 weeks. The supplement will be combined with a concurrent training regime consisting of resistance and high intensity interval training. Subjects will be tested for percent body fat to determine body composition. Further, they will also be tested for maximal strength (squat and bench), maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption (VO2max). And finally, subjects will be tested for health and hormone markers in the blood. All of these measures will be compared against a placebo group participating in the same exercise intervention.
Interventions
STS will be given every day in accordance to company guidelines for 12 weeks.
Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks.
Sponsors
Study design
Masking description
Double blind, placebo and supplement intervention
Intervention model description
A 12-week training model with testing weeks at baseline, mid point (week 7) and post-training.
Eligibility
Inclusion criteria
1. participate in the 3-4 week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins) 2. have at least 1 year of recreational exercise with a minimum of three times a week
Exclusion criteria
1. Prior steroid use 2. History of tumors 3. Pre-existing musculoskeletal disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat as Measured by Bod Pod | Baseline,Week 7, Week 14 | Changes in percent body fat |
| Change in Strength as Measured by Bench and Squat One Repetition Maximum | Baseline, Week 7, Week 14 | Changes in strength measures for both bench press and back squat |
| Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Baseline,Week 7,Week 14 | Changes in maximal oxygen consumption |
| Change in Serum Hormone Concentrations | Baseline,Week 7,Week 14 | Changes in Testosterone levels |
| Change in Strength as Measured by Bench One Repetition Maximum | Baseline, Week 7, Week 14 | Changes in strength measures for bench press |
| Change in Strength as Measured by Squat One Repetition Maximum | Baseline, Week 7, Week 14 | Changes in strength measures for Squat |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shroom Tech Sport Shroom Tech Sport is a multi-ingredient performance supplement taken, in pill form, prior to work outs to enhance workout performance.
Shroom Tech Sport: STS will be given every day in accordance to company guidelines for 12 weeks. | 10 |
| Placebo The placebo is a calorie matched sugar pill that will be taken in the same fashion as the STS pill.
Placebo: Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks. | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Compliance | 3 | 2 |
| Overall Study | Found to be Hypogonadal | 1 | 0 |
| Overall Study | Injury Sustained Outside Study | 1 | 0 |
Baseline characteristics
| Characteristic | Shroom Tech Sport | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 21.5 Years STANDARD_DEVIATION 1.2 | 22.5 Years STANDARD_DEVIATION 2.7 | 22 Years STANDARD_DEVIATION 2 |
| BMI | 24.2 kg/m^2 STANDARD_DEVIATION 1.8 | 24.6 kg/m^2 STANDARD_DEVIATION 2.7 | 24.4 kg/m^2 STANDARD_DEVIATION 2.3 |
| Height | 176.4 cm STANDARD_DEVIATION 7.2 | 175.9 cm STANDARD_DEVIATION 3.4 | 176.2 cm STANDARD_DEVIATION 5.3 |
| Percentage of Body Fat | 15.5 Percent STANDARD_DEVIATION 5.8 | 16.2 Percent STANDARD_DEVIATION 6.7 | 15.9 Percent STANDARD_DEVIATION 6.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
| Total Strength | 223 kg STANDARD_DEVIATION 29 | 217 kg STANDARD_DEVIATION 40 | 220 kg STANDARD_DEVIATION 35 |
| VO2max (ml/kg/min) | 54.3 ml/kg/min STANDARD_DEVIATION 6.7 | 54.3 ml/kg/min STANDARD_DEVIATION 5.7 | 54.3 ml/kg/min STANDARD_DEVIATION 6.4 |
| Weight | 75.4 kg STANDARD_DEVIATION 8.1 | 76 kg STANDARD_DEVIATION 8.8 | 75.7 kg STANDARD_DEVIATION 8.5 |
| Years of Prior Training Experience | 6.4 years STANDARD_DEVIATION 2.8 | 5.8 years STANDARD_DEVIATION 2.7 | 6.1 years STANDARD_DEVIATION 2.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 1 / 10 | 2 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Change in Body Fat as Measured by Bod Pod
Changes in percent body fat
Time frame: Baseline,Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Body Fat as Measured by Bod Pod | Week 7 | 14.8 Percent Body Fat | Standard Deviation 7.2 |
| Shroom Tech Sport | Change in Body Fat as Measured by Bod Pod | Baseline | 15.5 Percent Body Fat | Standard Deviation 5.8 |
| Shroom Tech Sport | Change in Body Fat as Measured by Bod Pod | Week 14 | 14.2 Percent Body Fat | Standard Deviation 6.6 |
| Placebo | Change in Body Fat as Measured by Bod Pod | Baseline | 16.2 Percent Body Fat | Standard Deviation 6.7 |
| Placebo | Change in Body Fat as Measured by Bod Pod | Week 7 | 15.3 Percent Body Fat | Standard Deviation 6.5 |
| Placebo | Change in Body Fat as Measured by Bod Pod | Week 14 | 14.3 Percent Body Fat | Standard Deviation 6.4 |
Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol
Changes in maximal oxygen consumption
Time frame: Baseline,Week 7,Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Baseline | 54.3 ml/kg/min | Standard Deviation 6.7 |
| Shroom Tech Sport | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Week 7 | 55.7 ml/kg/min | Standard Deviation 6.4 |
| Shroom Tech Sport | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Week 14 | 56.5 ml/kg/min | Standard Deviation 4.8 |
| Placebo | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Baseline | 54.3 ml/kg/min | Standard Deviation 5.7 |
| Placebo | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Week 7 | 56.0 ml/kg/min | Standard Deviation 6 |
| Placebo | Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol | Week 14 | 55.7 ml/kg/min | Standard Deviation 5.7 |
Change in Serum Hormone Concentrations
Changes in Cortisol Levels
Time frame: Baseline,Week 7,Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Baseline | 19.7 ug/dL | Standard Deviation 5.2 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 7 | 18.7 ug/dL | Standard Deviation 4.2 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 14 | 16.4 ug/dL | Standard Deviation 4.5 |
| Placebo | Change in Serum Hormone Concentrations | Baseline | 17.6 ug/dL | Standard Deviation 4.6 |
| Placebo | Change in Serum Hormone Concentrations | Week 7 | 17.9 ug/dL | Standard Deviation 6.1 |
| Placebo | Change in Serum Hormone Concentrations | Week 14 | 16.6 ug/dL | Standard Deviation 4.3 |
Change in Serum Hormone Concentrations
Changes in Testosterone levels
Time frame: Baseline,Week 7,Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 7 | 5.2 ng/ml | Standard Deviation 1.1 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 14 | 5.0 ng/ml | Standard Deviation 1.8 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Baseline | 5.9 ng/ml | Standard Deviation 1.1 |
| Placebo | Change in Serum Hormone Concentrations | Baseline | 5.8 ng/ml | Standard Deviation 1.2 |
| Placebo | Change in Serum Hormone Concentrations | Week 7 | 5.7 ng/ml | Standard Deviation 1.6 |
| Placebo | Change in Serum Hormone Concentrations | Week 14 | 5.7 ng/ml | Standard Deviation 1.4 |
Change in Serum Hormone Concentrations
Changes in IGF-I Levels
Time frame: Baseline, Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Baseline | 87.3 ng/ml | Standard Deviation 22.8 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 7 | 92.4 ng/ml | Standard Deviation 15.5 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 14 | 94.1 ng/ml | Standard Deviation 27.1 |
| Placebo | Change in Serum Hormone Concentrations | Baseline | 83.9 ng/ml | Standard Deviation 19.1 |
| Placebo | Change in Serum Hormone Concentrations | Week 7 | 82.6 ng/ml | Standard Deviation 21.4 |
| Placebo | Change in Serum Hormone Concentrations | Week 14 | 80.3 ng/ml | Standard Deviation 20.8 |
Change in Serum Hormone Concentrations
Changes in Sex Hormone Binding Globulin Levels
Time frame: Baseline, Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Baseline | 27.0 nmol/L | Standard Deviation 6.7 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 7 | 29.0 nmol/L | Standard Deviation 11.8 |
| Shroom Tech Sport | Change in Serum Hormone Concentrations | Week 14 | 28.5 nmol/L | Standard Deviation 7.7 |
| Placebo | Change in Serum Hormone Concentrations | Baseline | 29.0 nmol/L | Standard Deviation 14.2 |
| Placebo | Change in Serum Hormone Concentrations | Week 7 | 30.6 nmol/L | Standard Deviation 17.3 |
| Placebo | Change in Serum Hormone Concentrations | Week 14 | 29.2 nmol/L | Standard Deviation 14.2 |
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Changes in strength measures for both bench press and back squat
Time frame: Baseline, Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Baseline | 223 kg | Standard Deviation 29 |
| Shroom Tech Sport | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Week 7 | 222 kg | Standard Deviation 29 |
| Shroom Tech Sport | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Week 14 | 234 kg | Standard Deviation 28 |
| Placebo | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Baseline | 217 kg | Standard Deviation 40 |
| Placebo | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Week 7 | 222 kg | Standard Deviation 39 |
| Placebo | Change in Strength as Measured by Bench and Squat One Repetition Maximum | Week 14 | 232 kg | Standard Deviation 49 |
Change in Strength as Measured by Bench One Repetition Maximum
Changes in strength measures for bench press
Time frame: Baseline, Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Strength as Measured by Bench One Repetition Maximum | Baseline | 100 kg | Standard Deviation 14 |
| Shroom Tech Sport | Change in Strength as Measured by Bench One Repetition Maximum | Week 7 | 98 kg | Standard Deviation 12 |
| Shroom Tech Sport | Change in Strength as Measured by Bench One Repetition Maximum | Week 14 | 102 kg | Standard Deviation 14 |
| Placebo | Change in Strength as Measured by Bench One Repetition Maximum | Baseline | 100 kg | Standard Deviation 20 |
| Placebo | Change in Strength as Measured by Bench One Repetition Maximum | Week 7 | 100 kg | Standard Deviation 19 |
| Placebo | Change in Strength as Measured by Bench One Repetition Maximum | Week 14 | 105 kg | Standard Deviation 18 |
Change in Strength as Measured by Squat One Repetition Maximum
Changes in strength measures for Squat
Time frame: Baseline, Week 7, Week 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shroom Tech Sport | Change in Strength as Measured by Squat One Repetition Maximum | Baseline | 123 kg | Standard Deviation 16 |
| Shroom Tech Sport | Change in Strength as Measured by Squat One Repetition Maximum | Week 7 | 128 kg | Standard Deviation 16 |
| Shroom Tech Sport | Change in Strength as Measured by Squat One Repetition Maximum | Week 14 | 132 kg | Standard Deviation 15 |
| Placebo | Change in Strength as Measured by Squat One Repetition Maximum | Baseline | 118 kg | Standard Deviation 22 |
| Placebo | Change in Strength as Measured by Squat One Repetition Maximum | Week 7 | 123 kg | Standard Deviation 22 |
| Placebo | Change in Strength as Measured by Squat One Repetition Maximum | Week 14 | 128 kg | Standard Deviation 24 |