Trial Outcomes & Findings for Effects of Shroom Tech Sport Supplementation and Concurrent Training (NCT NCT02383017)
NCT ID: NCT02383017
Last Updated: 2020-12-17
Results Overview
Changes in percent body fat
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline,Week 7, Week 14
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
Shroom Tech Sport
This group consumed Shroom Tech Sport in accordance with manufacturer's instructions (one pill per 23kg (50lbs)) 45 minutes prior to exercise and testing and with breakfast on non-training days.
|
Placebo
This group consumed the placebo in accordance with the instructions provided for Shroom Tech Sport. Participants consumed one pill per 23kg (50lbs) 45 minutes before exercise and testing and with breakfast on non-training days.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Shroom Tech Sport
This group consumed Shroom Tech Sport in accordance with manufacturer's instructions (one pill per 23kg (50lbs)) 45 minutes prior to exercise and testing and with breakfast on non-training days.
|
Placebo
This group consumed the placebo in accordance with the instructions provided for Shroom Tech Sport. Participants consumed one pill per 23kg (50lbs) 45 minutes before exercise and testing and with breakfast on non-training days.
|
|---|---|---|
|
Overall Study
Injury Sustained Outside Study
|
1
|
0
|
|
Overall Study
Compliance
|
3
|
2
|
|
Overall Study
Found to be Hypogonadal
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Shroom Tech Sport
n=10 Participants
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.
|
Placebo
n=11 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.5 Years
STANDARD_DEVIATION 1.2 • n=10 Participants
|
22.5 Years
STANDARD_DEVIATION 2.7 • n=11 Participants
|
22 Years
STANDARD_DEVIATION 2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
|
Height
|
176.4 cm
STANDARD_DEVIATION 7.2 • n=10 Participants
|
175.9 cm
STANDARD_DEVIATION 3.4 • n=11 Participants
|
176.2 cm
STANDARD_DEVIATION 5.3 • n=21 Participants
|
|
Weight
|
75.4 kg
STANDARD_DEVIATION 8.1 • n=10 Participants
|
76 kg
STANDARD_DEVIATION 8.8 • n=11 Participants
|
75.7 kg
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
BMI
|
24.2 kg/m^2
STANDARD_DEVIATION 1.8 • n=10 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 2.7 • n=11 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 2.3 • n=21 Participants
|
|
Years of Prior Training Experience
|
6.4 years
STANDARD_DEVIATION 2.8 • n=10 Participants
|
5.8 years
STANDARD_DEVIATION 2.7 • n=11 Participants
|
6.1 years
STANDARD_DEVIATION 2.8 • n=21 Participants
|
|
Percentage of Body Fat
|
15.5 Percent
STANDARD_DEVIATION 5.8 • n=10 Participants
|
16.2 Percent
STANDARD_DEVIATION 6.7 • n=11 Participants
|
15.9 Percent
STANDARD_DEVIATION 6.3 • n=21 Participants
|
|
Total Strength
|
223 kg
STANDARD_DEVIATION 29 • n=10 Participants
|
217 kg
STANDARD_DEVIATION 40 • n=11 Participants
|
220 kg
STANDARD_DEVIATION 35 • n=21 Participants
|
|
VO2max (ml/kg/min)
|
54.3 ml/kg/min
STANDARD_DEVIATION 6.7 • n=10 Participants
|
54.3 ml/kg/min
STANDARD_DEVIATION 5.7 • n=11 Participants
|
54.3 ml/kg/min
STANDARD_DEVIATION 6.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline,Week 7, Week 14Changes in percent body fat
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Body Fat as Measured by Bod Pod
Baseline
|
15.5 Percent Body Fat
Standard Deviation 5.8
|
16.2 Percent Body Fat
Standard Deviation 6.7
|
|
Change in Body Fat as Measured by Bod Pod
Week 7
|
14.8 Percent Body Fat
Standard Deviation 7.2
|
15.3 Percent Body Fat
Standard Deviation 6.5
|
|
Change in Body Fat as Measured by Bod Pod
Week 14
|
14.2 Percent Body Fat
Standard Deviation 6.6
|
14.3 Percent Body Fat
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Baseline, Week 7, Week 14Changes in strength measures for both bench press and back squat
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Baseline
|
223 kg
Standard Deviation 29
|
217 kg
Standard Deviation 40
|
|
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Week 7
|
222 kg
Standard Deviation 29
|
222 kg
Standard Deviation 39
|
|
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Week 14
|
234 kg
Standard Deviation 28
|
232 kg
Standard Deviation 49
|
PRIMARY outcome
Timeframe: Baseline,Week 7,Week 14Changes in maximal oxygen consumption
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol
Baseline
|
54.3 ml/kg/min
Standard Deviation 6.7
|
54.3 ml/kg/min
Standard Deviation 5.7
|
|
Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol
Week 7
|
55.7 ml/kg/min
Standard Deviation 6.4
|
56.0 ml/kg/min
Standard Deviation 6.0
|
|
Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol
Week 14
|
56.5 ml/kg/min
Standard Deviation 4.8
|
55.7 ml/kg/min
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Baseline,Week 7,Week 14Changes in Testosterone levels
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Serum Hormone Concentrations
Baseline
|
5.9 ng/ml
Standard Deviation 1.1
|
5.8 ng/ml
Standard Deviation 1.2
|
|
Change in Serum Hormone Concentrations
Week 7
|
5.2 ng/ml
Standard Deviation 1.1
|
5.7 ng/ml
Standard Deviation 1.6
|
|
Change in Serum Hormone Concentrations
Week 14
|
5.0 ng/ml
Standard Deviation 1.8
|
5.7 ng/ml
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline,Week 7,Week 14Changes in Cortisol Levels
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Serum Hormone Concentrations
Baseline
|
19.7 ug/dL
Standard Deviation 5.2
|
17.6 ug/dL
Standard Deviation 4.6
|
|
Change in Serum Hormone Concentrations
Week 7
|
18.7 ug/dL
Standard Deviation 4.2
|
17.9 ug/dL
Standard Deviation 6.1
|
|
Change in Serum Hormone Concentrations
Week 14
|
16.4 ug/dL
Standard Deviation 4.5
|
16.6 ug/dL
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline, Week 7, Week 14Changes in IGF-I Levels
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Serum Hormone Concentrations
Baseline
|
87.3 ng/ml
Standard Deviation 22.8
|
83.9 ng/ml
Standard Deviation 19.1
|
|
Change in Serum Hormone Concentrations
Week 7
|
92.4 ng/ml
Standard Deviation 15.5
|
82.6 ng/ml
Standard Deviation 21.4
|
|
Change in Serum Hormone Concentrations
Week 14
|
94.1 ng/ml
Standard Deviation 27.1
|
80.3 ng/ml
Standard Deviation 20.8
|
PRIMARY outcome
Timeframe: Baseline, Week 7, Week 14Changes in Sex Hormone Binding Globulin Levels
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Serum Hormone Concentrations
Week 7
|
29.0 nmol/L
Standard Deviation 11.8
|
30.6 nmol/L
Standard Deviation 17.3
|
|
Change in Serum Hormone Concentrations
Baseline
|
27.0 nmol/L
Standard Deviation 6.7
|
29.0 nmol/L
Standard Deviation 14.2
|
|
Change in Serum Hormone Concentrations
Week 14
|
28.5 nmol/L
Standard Deviation 7.7
|
29.2 nmol/L
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: Baseline, Week 7, Week 14Changes in strength measures for bench press
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Strength as Measured by Bench One Repetition Maximum
Baseline
|
100 kg
Standard Deviation 14
|
100 kg
Standard Deviation 20
|
|
Change in Strength as Measured by Bench One Repetition Maximum
Week 7
|
98 kg
Standard Deviation 12
|
100 kg
Standard Deviation 19
|
|
Change in Strength as Measured by Bench One Repetition Maximum
Week 14
|
102 kg
Standard Deviation 14
|
105 kg
Standard Deviation 18
|
PRIMARY outcome
Timeframe: Baseline, Week 7, Week 14Changes in strength measures for Squat
Outcome measures
| Measure |
Shroom Tech Sport
n=10 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Change in Strength as Measured by Squat One Repetition Maximum
Baseline
|
123 kg
Standard Deviation 16
|
118 kg
Standard Deviation 22
|
|
Change in Strength as Measured by Squat One Repetition Maximum
Week 7
|
128 kg
Standard Deviation 16
|
123 kg
Standard Deviation 22
|
|
Change in Strength as Measured by Squat One Repetition Maximum
Week 14
|
132 kg
Standard Deviation 15
|
128 kg
Standard Deviation 24
|
Adverse Events
Shroom Tech Sport
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Shroom Tech Sport
n=10 participants at risk
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.
|
Placebo
n=11 participants at risk
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.
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Dry Mouth
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Difficulty Sleeping
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place