Nutritional SupplementsNB9NCT03039829
Safety of Different Forms of Creatine
A study testing Creatine nitrate, low dose and Creatine nitrate, high dose in people with Nutritional Supplements, run by Texas A&M University.
Trial summary
This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Supplements
- What is being tested?
- Creatine nitrate, low dose and Creatine nitrate, high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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
- Apparently healthy
- At least 6 months immediate prior history of resistance training including bench press and leg press or squat
Who cannot join
- A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
- Use of prescription medication (birth control is allowed)
- Pregnant or nursing or plan to become pregnant during the next month
- Creatine or nitrate use in the last eight weeks
- History of smoking
- History of drinking (i.e., 12 drinks per week or more)
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene)
About this study
Official title: Short-Term Safety and Dose Effects of Different Forms of Creatine
This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.
Read the detailed description
This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.
- Conditions
- Nutritional Supplements
- Being tested
- Creatine nitrate, low dose, Creatine nitrate, high dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine nitrate, low doseDietary supplement
Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
Creatine nitrate, high doseDietary supplement
Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
PlaceboDietary supplement
Placebo at 6.0 grams (6.0 grams dextrose)
| Study group | Role | What they receive |
|---|---|---|
| Creatine nitrate, low dose | Experimental | Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose) Receives: Dietary Supplement: Creatine nitrate, low dose |
| Creatine nitrate, high dose | Active comparator | Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate) Receives: Dietary Supplement: Creatine nitrate, high dose |
| Placebo | Placebo comparator | Placebo at 6.0 grams dextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the blood pressure response to creatine nitrate ingestion
Measured: 7 days
Measuring the heart rate response to creatine nitrate ingestion
Measured: 7 days
Secondary outcomes (4)
Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
Measured: 7 days
Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
Measured: 7 days
Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
Measured: 7 days
Measuring self-reported side effects of creatine nitrate ingestion
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupplementsStudies 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
- 38 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
- NCT03039829
- Sponsor's protocol ID
- IRB2015-0684
- Acronym
- NB9
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 1 Feb 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 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Safety and Dose Effects of Different Forms of Creatine
- ClinicalTrials.gov ID
- NCT03039829
- Acronym / sponsor ID
- NB9 / IRB2015-0684
- Conditions
- Nutritional Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Feb 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 will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.
Detailed description
This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Creatine nitrate, low dose | Experimental | Dietary Supplement: Creatine nitrate, low doseCreatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose) |
| Creatine nitrate, high dose | Active comparator | Dietary Supplement: Creatine nitrate, high doseCreatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo at 6.0 grams dextrose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apparently healthy
- At least 6 months immediate prior history of resistance training including bench press and leg press or squat
Key exclusion criteria (7 listed)
- A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
- Use of prescription medication (birth control is allowed)
- Pregnant or nursing or plan to become pregnant during the next month
- Creatine or nitrate use in the last eight weeks
- 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 |
|---|---|---|
| Creatine nitrate, low doseCreatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose) | Dietary supplement | Creatine nitrate, low dose |
| Creatine nitrate, high doseCreatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate) | Dietary supplement | Creatine nitrate, high dose |
| PlaceboPlacebo at 6.0 grams (6.0 grams dextrose) | Dietary supplement | Placebo |
Primary outcome
Measuring the blood pressure response to creatine nitrate ingestion
Time frame: 7 days
Measuring the heart rate response to creatine nitrate ingestion
Time frame: 7 days
4 secondary outcomes
Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
Time frame: 7 days
Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
Time frame: 7 days
Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
Time frame: 7 days
Measuring self-reported side effects of creatine nitrate ingestion
Time frame: 7 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 1 Feb 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 Creatine nitrate, low dose and Creatine nitrate, high dose in people with Nutritional Supplements, 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 7 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 1 Feb 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?
Measuring the blood pressure response to creatine nitrate ingestion (time frame: 7 days). The study lists 2 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 1 Feb 2017.