Exercise ErgogenicsNB6NCT03022604
Assessment of a Pre-Workout Supplement
A study testing C4/Generation 4 and C450X in people with Exercise Ergogenics, run by Texas A&M University.
Trial summary
This study is assessing the effects of a pre-workout dietary supplement. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Ergogenics
- What is being tested?
- C4/Generation 4 and C450X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be apparently healthy males and/or females between the ages of 18 and 40
- Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat
Who cannot join
- Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
- Participants who currently use any prescription medication
- Participants who are intolerant to caffeine and/or other natural stimulants
- Participants who are pregnant or lactating women
- Participants who have a history of smoking
- Participants who drink excessively (12 drinks per week)
About this study
Official title: Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement
This study is assessing the effects of a pre-workout dietary supplement.
Read the detailed description
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
- Conditions
- Exercise Ergogenics
- Being tested
- C4/Generation 4, C450X, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C4/Generation 4Dietary supplement
12 grams of C4/Generation 4
C450XDietary supplement
12 grams of C450X
PlaceboDietary supplement
12 grams of flavored dextrose
| Study group | Role | What they receive |
|---|---|---|
| C4/Generation 4 | Experimental | 12 grams of C4/Generation 4 Extreme Receives: Dietary Supplement: C4/Generation 4 |
| C450X | Active comparator | 12 grams of C4X (150% of regular dose) Receives: Dietary Supplement: C450X |
| Placebo | Placebo comparator | 12 grams of flavored dextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on the Word Recall Test
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on bench press power output
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on leg press power output
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the bench press
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the leg press
Measured: Seven Days
Secondary outcomes (5)
Effects of a Pre-Workout Dietary Supplement on energy expenditure
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on heart rate
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on blood pressure
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on ECG's
Measured: Seven Days
Effects of a Pre-Workout Dietary Supplement on blood lab results
Measured: Seven Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ErgogenicsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrabolt
- Responsible party
- Sponsor
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022604
- Sponsor's protocol ID
- IRB2014-0795F
- Acronym
- NB6
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement
- ClinicalTrials.gov ID
- NCT03022604
- Acronym / sponsor ID
- NB6 / IRB2014-0795F
- Conditions
- Exercise Ergogenics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is assessing the effects of a pre-workout dietary supplement.
Detailed description
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C4/Generation 4 | Experimental | Dietary Supplement: C4/Generation 412 grams of C4/Generation 4 Extreme |
| C450X | Active comparator | Dietary Supplement: C450X12 grams of C4X (150% of regular dose) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo12 grams of flavored dextrose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be apparently healthy males and/or females between the ages of 18 and 40
- Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat
Key exclusion criteria (6 listed)
- Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
- Participants who currently use any prescription medication
- Participants who are intolerant to caffeine and/or other natural stimulants
- Participants who are pregnant or lactating women
- Participants who have a history of smoking
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 |
|---|---|---|
| C4/Generation 412 grams of C4/Generation 4 | Dietary supplement | C4/Generation 4 |
| C450X12 grams of C450X | Dietary supplement | C450X |
| Placebo12 grams of flavored dextrose | Dietary supplement | Placebo |
Primary outcome
Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on the Word Recall Test
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on bench press power output
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on leg press power output
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the bench press
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the leg press
Time frame: Seven Days
5 secondary outcomes
Effects of a Pre-Workout Dietary Supplement on energy expenditure
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on heart rate
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on blood pressure
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on ECG's
Time frame: Seven Days
Effects of a Pre-Workout Dietary Supplement on blood lab results
Time frame: Seven Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing C4/Generation 4 and C450X in people with Exercise Ergogenics, run by Texas A&M University.
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 6 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test (time frame: Seven Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.