Dietary ModificationNB1NCT02952014
Assessment of a Pre-Workout Dietary Supplement
A study testing C4 Extreme and C4 Extreme (without Advantra Z in people with Dietary Modification, run by Texas A&M University at 1 site in United States.
Trial summary
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- C4 Extreme and C4 Extreme (without Advantra Z
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2014
- 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
- you are an apparently healthy and recreationally active man or woman between the ages of 18 and 40;
- you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;
Who cannot join
- you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia and/or cardiovascular disease;
- you are currently using prescription medications;
- you have an intolerance to caffeine and/or other natural stimulants;
- you are pregnant or a lactating female or plan to become pregnant with the next month;
- you have a history of smoking;
- you drink excessively (i.e., 12 drinks per week or more);
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Laboratory
College Station, Texas, 77843
About this study
Official title: Pharmacokinetic, Thermogenic, Hemodynamic, Ergogenic Assessment of a Pre-Workout Dietary Supplement
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
Read the detailed description
A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.
- Conditions
- Dietary Modification
- Being tested
- C4 Extreme, C4 Extreme (without Advantra Z, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C4 ExtremeDietary supplement
Pre-Workout Dietary Supplement
C4 Extreme (without Advantra ZDietary supplement
Pre-Workout Dietary Supplement
PlaceboDietary supplement
Pre-Workout Dietary Supplement
| Study group | Role | What they receive |
|---|---|---|
| C4 Extreme | Experimental | One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 10 mg synephrine, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. Receives: Dietary Supplement: C4 Extreme |
| C4 Extreme (without Advantra Z) | Active comparator | One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. Receives: Dietary Supplement: C4 Extreme (without Advantra Z |
| Placebo | Placebo comparator | One dose of flavored placebo (powder mixed with water) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test).
Measured: Three weeks
Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale.
Measured: Three weeks
Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure.
Measured: Three weeks
Optimize nutrient delivery prior to exercise by assessing Heart Rate.
Measured: Three weeks
Optimize nutrient delivery prior to exercise by assessing Blood Pressure.
Measured: Three weeks
Optimize nutrient delivery prior to exercise by assessing ECG.
Measured: Three weeks
Secondary outcomes (4)
Measure standard clinical chemistry panels in the blood to evaluate safety.
Measured: Three weeks
Measure Heart Rate to evaluate safety.
Measured: Three weeks
Measure Blood Pressure to evaluate safety.
Measured: Three weeks
Measure ECG to evaluate safety.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies 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
- 31 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
- NCT02952014
- Sponsor's protocol ID
- IRB2014-0022FX
- Acronym
- NB1
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 2017.
PubMed 28096758
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic, Thermogenic, Hemodynamic, Ergogenic Assessment of a Pre-Workout Dietary Supplement
- ClinicalTrials.gov ID
- NCT02952014
- Acronym / sponsor ID
- NB1 / IRB2014-0022FX
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Nov 2016 (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.
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
Detailed description
A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.
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 Extreme | Experimental | Dietary Supplement: C4 ExtremeOne dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 10 mg synephrine, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. |
| C4 Extreme (without Advantra Z) | Active comparator | Dietary Supplement: C4 Extreme (without Advantra ZOne dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne dose of flavored placebo (powder mixed with water) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- you are an apparently healthy and recreationally active man or woman between the ages of 18 and 40;
- you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;
Key exclusion criteria (6 listed)
- you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia and/or cardiovascular disease;
- you are currently using prescription medications;
- you have an intolerance to caffeine and/or other natural stimulants;
- you are pregnant or a lactating female or plan to become pregnant with the next month;
- you 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 ExtremePre-Workout Dietary Supplement | Dietary supplement | C4 Extreme |
| C4 Extreme (without Advantra ZPre-Workout Dietary Supplement | Dietary supplement | C4 Extreme (without Advantra Z) |
| PlaceboPre-Workout Dietary Supplement | Dietary supplement | Placebo |
Primary outcome
Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test).
Time frame: Three weeks
Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale.
Time frame: Three weeks
Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure.
Time frame: Three weeks
Optimize nutrient delivery prior to exercise by assessing Heart Rate.
Time frame: Three weeks
Optimize nutrient delivery prior to exercise by assessing Blood Pressure.
Time frame: Three weeks
Optimize nutrient delivery prior to exercise by assessing ECG.
Time frame: Three weeks
4 secondary outcomes
Measure standard clinical chemistry panels in the blood to evaluate safety.
Time frame: Three weeks
Measure Heart Rate to evaluate safety.
Time frame: Three weeks
Measure Blood Pressure to evaluate safety.
Time frame: Three weeks
Measure ECG to evaluate safety.
Time frame: Three weeks
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 2 Nov 2016.
- Derived from this study: PubMed 28096758Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C4 Extreme and C4 Extreme (without Advantra Z in people with Dietary Modification, run by Texas A&M 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 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 2 Nov 2016. 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?
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?
Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test). (time frame: Three weeks). The study lists 6 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 NCT02952014, 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 2 Nov 2016.