Dietary ModificationNB2NCT02999581
Effects of a Pre-Workout Dietary Supplement on Training Adaptations
A study testing C4 Extreme, C4 Extreme (without Advantra Z) in people with Dietary Modification, run by Texas A&M University.
Trial summary
The purpose of this study is to examine the effects of a pre-workout dietary supplement during resistance training on training adaptations. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- C4 Extreme, C4 Extreme (without Advantra Z)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- you are an apparently healthy and recreationally active male 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, hypotension, 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 have a history of smoking;
- you drink excessively (i.e., 12 drinks per week or more);
About this study
Official title: Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes
The purpose of this study is to examine the effects of a pre-workout dietary supplement during resistance training on training adaptations.
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 effects of ingesting a pre-workout dietary supplement during resistance training on training adaptations.
- Conditions
- Dietary Modification
- Being tested
- C4 Extreme, C4 Extreme (without Advantra Z)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C4 Extreme, C4 Extreme (without Advantra Z)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 alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. Receives: Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z) |
| 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 alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. Receives: Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z) |
| Placebo | Placebo comparator | One dose of flavored placebo (powder mixed with water) Receives: Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the effects of C4 supplementation during resistance training by assessing body water
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing body composition
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels
Measured: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS)
Measured: Eight weeks
Secondary outcomes (4)
Measure standard clinical chemistry panels in the blood to evaluate safety
Measured: Eight weeks
Record side effects to evaluate safety
Measured: Eight weeks
Measure heart rate to evaluate safety
Measured: Eight weeks
Measure blood pressure to evaluate safety
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrabolt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999581
- Sponsor's protocol ID
- IRB2014-0079FX
- Acronym
- NB2
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jung YP, Earnest CP, Koozehchian M, Cho M, Barringer N, Walker D, Rasmussen C, Greenwood M, Murano PS, Kreider RB. Effects of ingesting a pre-workout dietary supplement with and without synephrine for 8 weeks on training adaptations in resistance-trained males. J Int Soc Sports Nutr. 2017 Jan 3;14:1. doi: 10.1186/s12970-016-0158-3. eCollection 2017.
PubMed 28096757
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes
- ClinicalTrials.gov ID
- NCT02999581
- Acronym / sponsor ID
- NB2 / IRB2014-0079FX
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Dec 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 effects of a pre-workout dietary supplement during resistance training on training adaptations.
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 effects of ingesting a pre-workout dietary supplement during resistance training on training adaptations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C4 Extreme | Experimental | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. |
| C4 Extreme (without Advantra Z) | Active comparator | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. |
| Placebo | Placebo comparator | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)One dose of flavored placebo (powder mixed with water) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- you are an apparently healthy and recreationally active male 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 (5 listed)
- you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, 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 have a history of smoking;
- you drink excessively (i.e., 12 drinks per week or more);
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 Extreme, C4 Extreme (without Advantra Z) | Dietary supplement | C4 Extreme, C4 Extreme (without Advantra Z), Placebo |
Primary outcome
Examine the effects of C4 supplementation during resistance training by assessing body water
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing body composition
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels
Time frame: Eight weeks
Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS)
Time frame: Eight weeks
4 secondary outcomes
Measure standard clinical chemistry panels in the blood to evaluate safety
Time frame: Eight weeks
Record side effects to evaluate safety
Time frame: Eight weeks
Measure heart rate to evaluate safety
Time frame: Eight weeks
Measure blood pressure to evaluate safety
Time frame: Eight 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 21 Dec 2016.
- Derived from this study: PubMed 28096757Jung YP, Earnest CP, Koozehchian M, Cho M, Barringer N, Walker D, Rasmussen C, Greenwood M, Murano PS, Kreider RB. Effects of ingesting a pre-workout dietary supplement with and without synephrine for 8 weeks on training adaptations in resistance-trained males. J Int Soc Sports Nutr. 2017 Jan 3;14:1. doi: 10.1186/s12970-016-0158-3. 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing C4 Extreme, C4 Extreme (without Advantra Z) in people with Dietary Modification, 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 5 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 21 Dec 2016. 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?
Examine the effects of C4 supplementation during resistance training by assessing body water (time frame: Eight weeks). 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?
On the ClinicalTrials.gov record for NCT02999581, 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 21 Dec 2016.