Dietary ModificationNB3NCT03000582
Assessment of Different Forms of Creatine
A study testing Creatine monohydrate, Creatine nitrate-1 and Creatine nitrate-2 in people with Dietary Modification, run by Texas A&M University.
Trial summary
The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Creatine monohydrate, Creatine nitrate-1 and Creatine nitrate-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- you are an apparently healthy and recreationally active male between the ages of 18 and 40;
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 a history of smoking;
- you drink excessively (i.e., 12 drinks per week or more);
- you have a recent history of creatine supplementation within six weeks of the start of supplementation;
About this study
Official title: Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine
The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.
Read the detailed description
Creatine nitrate contains several nutrients that may increase anaerobic exercise performance. Theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. Diet, physical activity and pharmaceutical interventions can all impact vascular function and health. The purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on FMD by analyzing the pharmacokinetics of creatine nitrate supplementation.
- Conditions
- Dietary Modification
- Being tested
- Creatine monohydrate, Creatine nitrate-1, Creatine nitrate-2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)
Creatine nitrate-1Dietary supplement
Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)
Creatine nitrate-2Dietary supplement
Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)
PlaceboDietary supplement
Placebo (6.5 g dextrose)
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | 5 gm creatine monohydrate, 1.5 gm dextrose Receives: Dietary Supplement: Creatine monohydrate |
| Creatine nitrate-1 | Active comparator | 1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose Receives: Dietary Supplement: Creatine nitrate-1 |
| Creatine nitrate-2 | Active comparator | 2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose Receives: Dietary Supplement: Creatine nitrate-2 |
| Placebo | Placebo comparator | 6.5 gm dextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine creatine vs. creatine nitrate supplementation by assessing body water
Measured: One day
Examine creatine vs. creatine nitrate supplementation by assessing body composition
Measured: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels
Measured: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels
Measured: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels
Measured: One day
Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography
Measured: One day
Secondary outcomes (4)
Measure standard clinical chemistry panels in the blood to evaluate safety
Measured: One day
Measure side effects to evaluate safety utilizing a side effects questionnaire
Measured: One day
Measure heart rate to evaluate safety
Measured: One day
Measure blood pressure to evaluate safety
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 13 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
- NCT03000582
- Sponsor's protocol ID
- IRB2014-0362F
- Acronym
- NB3
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 22 Dec 2016
- 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 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine
- ClinicalTrials.gov ID
- NCT03000582
- Acronym / sponsor ID
- NB3 / IRB2014-0362F
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 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 pharmacokinetics of creatine nitrate supplementation.
Detailed description
Creatine nitrate contains several nutrients that may increase anaerobic exercise performance. Theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. Diet, physical activity and pharmaceutical interventions can all impact vascular function and health. The purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on FMD by analyzing the pharmacokinetics of creatine nitrate supplementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate | Experimental | Dietary Supplement: Creatine monohydrate5 gm creatine monohydrate, 1.5 gm dextrose |
| Creatine nitrate-1 | Active comparator | Dietary Supplement: Creatine nitrate-11 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose |
| Creatine nitrate-2 | Active comparator | Dietary Supplement: Creatine nitrate-22 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo6.5 gm dextrose |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- you are an apparently healthy and recreationally active male between the ages of 18 and 40;
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 a history of smoking;
- you drink excessively (i.e., 12 drinks per week or more);
- you have a recent history of creatine supplementation within six weeks of the start of supplementation;
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 monohydrateCreatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose) | Dietary supplement | Creatine monohydrate |
| Creatine nitrate-1Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose) | Dietary supplement | Creatine nitrate-1 |
| Creatine nitrate-2Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose) | Dietary supplement | Creatine nitrate-2 |
| PlaceboPlacebo (6.5 g dextrose) | Dietary supplement | Placebo |
Primary outcome
Examine creatine vs. creatine nitrate supplementation by assessing body water
Time frame: One day
Examine creatine vs. creatine nitrate supplementation by assessing body composition
Time frame: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels
Time frame: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels
Time frame: One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels
Time frame: One day
Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography
Time frame: One day
4 secondary outcomes
Measure standard clinical chemistry panels in the blood to evaluate safety
Time frame: One day
Measure side effects to evaluate safety utilizing a side effects questionnaire
Time frame: One day
Measure heart rate to evaluate safety
Time frame: One day
Measure blood pressure to evaluate safety
Time frame: One day
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 22 Dec 2016.
- 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 Creatine monohydrate, Creatine nitrate-1 and Creatine nitrate-2 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 1 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 22 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 creatine vs. creatine nitrate supplementation by assessing body water (time frame: One day). 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?
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 22 Dec 2016.