Body CompositionNCT02383017

Effects of Shroom Tech Sport Supplementation and Concurrent Training

A study testing Shroom Tech Sport in people with Body Composition and Performance Measures, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Body Composition, Performance Measures, Hormone Profiles
What is being tested?: Shroom Tech Sport
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Feb 2015to 30 Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

participate in the 3-4 week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)
have at least 1 year of recreational exercise with a minimum of three times a week

Who cannot join

Prior steroid use
History of tumors
Pre-existing musculoskeletal disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute of Sports Science and Medicine, Florida State University
Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: Effects of Shroom Tech Sport Supplementation and Concurrent Training on Body Composition, Performance and Health in Collegiate-aged Men

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.

Conditions: Body Composition, Performance Measures, Hormone Profiles, Blood Lipid Profiles
Being tested: Shroom Tech Sport, Placebo
Keywords: Multi-ingredient performance supplement, High Intensity Interval Training, Concurrent training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shroom Tech SportDietary supplement
Also called STS
STS will be given every day in accordance to company guidelines for 12 weeks.
PlaceboDietary supplement
Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks.

Study groups in NCT02383017
Study group	Role	What they receive
Shroom Tech Sport	Experimental	Shroom Tech Sport is a multi-ingredient performance supplement taken, in pill form, prior to work outs to enhance workout performance. Receives: Dietary Supplement: Shroom Tech Sport
Placebo	Placebo comparator	The placebo is a calorie matched sugar pill that will be taken in the same fashion as the STS pill. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Fat as Measured by Bod Pod
Changes in percent body fat
Measured: Baseline,Week 7, Week 14
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Changes in strength measures for both bench press and back squat
Measured: Baseline, Week 7, Week 14
Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol
Changes in maximal oxygen consumption
Measured: Baseline,Week 7,Week 14
Change in Serum Hormone Concentrations
Changes in Testosterone levels
Measured: Baseline,Week 7,Week 14
Change in Serum Hormone Concentrations
Changes in Cortisol Levels
Measured: Baseline,Week 7,Week 14
Change in Serum Hormone Concentrations
Changes in IGF-I Levels
Measured: Baseline, Week 7, Week 14
Change in Serum Hormone Concentrations
Changes in Sex Hormone Binding Globulin Levels
Measured: Baseline, Week 7, Week 14
Change in Strength as Measured by Bench One Repetition Maximum
Changes in strength measures for bench press
Measured: Baseline, Week 7, Week 14
Change in Strength as Measured by Squat One Repetition Maximum
Changes in strength measures for Squat
Measured: Baseline, Week 7, Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201530 Jul 2016

First posted9 Mar 2015 (estimated)
Study startFeb 2015
Primary completion30 Jul 2016
Study completion30 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Body CompositionStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: A 12-week training model with testing weeks at baseline, mid point (week 7) and post-training.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02383017
Sponsor's protocol ID: Florida StateU
Status last verified: Dec 2020
First submitted: 7 Feb 2015
Last updated: 17 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kreipke PhD VC, Moffatt PhD RJ, Tanner Ma CJ, Ormsbee PhD MJ. Effects of Concurrent Training and a Multi-Ingredient Performance Supplement Containing Rhodiola rosea and Cordyceps sinensis on Body Composition, Performance, and Health in Active Men. J Diet Suppl. 2021;18(6):597-613. doi: 10.1080/19390211.2020.1822486. Epub 2020 Oct 20.
PubMed 33078636

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Body Composition trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Shroom Tech Sport Supplementation and Concurrent Training on Body Composition, Performance and Health in Collegiate-aged Men
ClinicalTrials.gov ID: NCT02383017
Acronym / sponsor ID: Florida StateU
Conditions: Body Composition, Performance Measures, Hormone Profiles, Blood Lipid Profiles
Keywords: Multi-ingredient performance supplement, High Intensity Interval Training, Concurrent training
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Study start: Feb 2015 (actual)
Primary completion: 30 Jul 2016 (actual)
Study completion: 30 Jul 2016 (actual)
First posted: 9 Mar 2015 (estimated)
Results: Posted 17 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: A 12-week training model with testing weeks at baseline, mid point (week 7) and post-training.

Arm	Type	Receives
Shroom Tech Sport	Experimental	Dietary Supplement: Shroom Tech SportShroom Tech Sport is a multi-ingredient performance supplement taken, in pill form, prior to work outs to enhance workout performance.
Placebo	Placebo comparator	Dietary Supplement: PlaceboThe placebo is a calorie matched sugar pill that will be taken in the same fashion as the STS pill.

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

participate in the 3-4 week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)
have at least 1 year of recreational exercise with a minimum of three times a week

Key exclusion criteria (3 listed)

Prior steroid use
History of tumors
Pre-existing musculoskeletal disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shroom Tech SportAlso: STSSTS will be given every day in accordance to company guidelines for 12 weeks.	Dietary supplement	Shroom Tech Sport
PlaceboPlacebo will be given in the same fashion as the STS pills guidelines for 12 weeks.	Dietary supplement	Placebo

Primary outcome

Change in Body Fat as Measured by Bod Pod
Time frame: Baseline,Week 7, Week 14
Changes in percent body fat
Change in Strength as Measured by Bench and Squat One Repetition Maximum
Time frame: 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
Time frame: Baseline,Week 7,Week 14
Changes in maximal oxygen consumption
Change in Serum Hormone Concentrations
Time frame: Baseline,Week 7,Week 14
Changes in Testosterone levels
Change in Serum Hormone Concentrations
Time frame: Baseline,Week 7,Week 14
Changes in Cortisol Levels
Change in Serum Hormone Concentrations
Time frame: Baseline, Week 7, Week 14
Changes in IGF-I Levels
Change in Serum Hormone Concentrations
Time frame: Baseline, Week 7, Week 14
Changes in Sex Hormone Binding Globulin Levels
Change in Strength as Measured by Bench One Repetition Maximum
Time frame: Baseline, Week 7, Week 14
Changes in strength measures for bench press
Change in Strength as Measured by Squat One Repetition Maximum
Time frame: Baseline, Week 7, Week 14
Changes in strength measures for Squat

Results and safety

Results posted to the registry on 17 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shroom Tech Sport	15	10
Placebo	13	11

Primary outcome: Change in Body Fat as Measured by Bod Pod

Time frame: Baseline,Week 7, Week 14. Mean (Standard Deviation). Unit: Percent Body Fat

Measure	Shroom Tech Sport n = 10	Placebo n = 11
Baseline	15.5 (5.8)	16.2 (6.7)
Week 7	14.8 (7.2)	15.3 (6.5)
Week 14	14.2 (6.6)	14.3 (6.4)

Primary outcome: Change in Strength as Measured by Bench and Squat One Repetition Maximum

Time frame: Baseline, Week 7, Week 14. Mean (Standard Deviation). Unit: kg

Measure	Shroom Tech Sport n = 10	Placebo n = 11
Baseline	223 (29)	217 (40)
Week 7	222 (29)	222 (39)
Week 14	234 (28)	232 (49)

Primary outcome: Change in Maximum Oxygen Consumption as Measured by VO2max Treadmill Protocol

Time frame: Baseline,Week 7,Week 14. Mean (Standard Deviation). Unit: ml/kg/min

Measure	Shroom Tech Sport n = 10	Placebo n = 11
Baseline	54.3 (6.7)	54.3 (5.7)
Week 7	55.7 (6.4)	56.0 (6.0)
Week 14	56.5 (4.8)	55.7 (5.7)

Primary outcome: Change in Serum Hormone Concentrations

Time frame: Baseline,Week 7,Week 14. Mean (Standard Deviation). Unit: ng/ml

Measure	Shroom Tech Sport n = 10	Placebo n = 11
Baseline	5.9 (1.1)	5.8 (1.2)
Week 7	5.2 (1.1)	5.7 (1.6)
Week 14	5.0 (1.8)	5.7 (1.4)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shroom Tech Sport	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Placebo	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33078636Kreipke PhD VC, Moffatt PhD RJ, Tanner Ma CJ, Ormsbee PhD MJ. Effects of Concurrent Training and a Multi-Ingredient Performance Supplement Containing Rhodiola rosea and Cordyceps sinensis on Body Composition, Performance, and Health in Active Men. J Diet Suppl. 2021;18(6):597-613. doi: 10.1080/19390211.2020.1822486. Epub 2020 Oct 20.

Related trials for Body Composition

Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Active, not recruitingObservational study
Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
Geriatric Assessment, Advanced Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Growing Little PEAPODS Study
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RecruitingObservational study
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Shroom Tech Sport in people with Body Composition and Performance Measures, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Fat as Measured by Bod Pod (time frame: Baseline,Week 7, Week 14). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02383017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.