Dietary SupplementationNB4NCT03003988
Physiological Effects of Creatine Supplementation in Active Males
A study testing Creatine monohydrate and Creatine nitrate in people with Dietary Supplementation, run by Texas A&M University.
Trial summary
This study was designed to examine how different forms of creatine impact active males. 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 Supplementation
- What is being tested?
- Creatine monohydrate and Creatine nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 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
- participants are apparently healthy and recreationally active males between the ages of 18 and 40;
- participants 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
- participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease;
- participants are currently using prescription medications;
- participants have a history of smoking;
- participants drink excessively (i.e., 12 drinks per week or more);
- participants have a recent history of creatine supplementation within six weeks of the start of supplementation;
About this study
Official title: Effects of 28 Days of Different Forms of Creatine Supplementation on Muscle Creatine, Body Composition and Exercise Performance in Recreationally Active Males
This study was designed to examine how different forms of creatine impact active males.
Read the detailed description
This study examined the effects of different formulations of creatine nitrate on muscle creatine content, body composition, anaerobic exercise capacity, bench press performance and clinical chemistry panels in recreationally active males.
- Conditions
- Dietary Supplementation
- Being tested
- Creatine monohydrate, Creatine nitrate, 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 (6.0 g) + dextrose (0.5 g)
Creatine nitrateDietary supplement
Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio)
PlaceboDietary supplement
Placebo (6.5 g dextrose)
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | Creatine monohydrate (6.0 g.) + dextrose (0.5 g.) Receives: Dietary Supplement: Creatine monohydrate |
| Creatine nitrate | Active comparator | Creatine nitrate (5.0 g. creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio). Receives: Dietary Supplement: Creatine nitrate |
| Placebo | Placebo comparator | 6.5 g. dextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water
Assessing Body Water through Bioelectrical Impedance Analysis (BIA)
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on Body Composition
Assessing Body Compositing through Dual-Energy X-Ray Absorptiometry (DXA)
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular creatine
Assessing intramuscular creatine using standard spectrophotometric methods using a microplate spectrophotometer
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular phosphocreatine
Assessing intramuscular phosphocreatine using standard spectrophotometric methods using a microplate spectrophotometer
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular ATP
Assessing intramuscular Adenosine Triphosphate (ATP) using standard spectrophotometric methods using a microplate spectrophotometer
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength
Assessing muscular strength through 1 Repetition Maximum (RM) testing
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance
Assessing muscular endurance through repetition to failure testing
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on anaerobic capacity
Assessing anaerobic capacity through 6 x 6 second sprints followed by a 30 second sprint on a Wingate bicycle ergometer
Measured: 28 Days
Secondary outcomes (3)
Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)
Assessing training volume using a calculator
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects
Assessing self-reported side effects using a side effects questionnaire
Measured: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on blood
Measure standard clinical chemistry panels in the blood to evaluate safety
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startSep 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.
- Other trials for Dietary SupplementationStudies 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
- 48 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
- NCT03003988
- Sponsor's protocol ID
- IRB2014-0503FX
- Acronym
- NB4
- Status last verified
- Jan 2017
- First submitted
- 14 Dec 2016
- Last updated
- 4 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 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 28 Days of Different Forms of Creatine Supplementation on Muscle Creatine, Body Composition and Exercise Performance in Recreationally Active Males
- ClinicalTrials.gov ID
- NCT03003988
- Acronym / sponsor ID
- NB4 / IRB2014-0503FX
- Conditions
- Dietary Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrabolt
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 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.
This study was designed to examine how different forms of creatine impact active males.
Detailed description
This study examined the effects of different formulations of creatine nitrate on muscle creatine content, body composition, anaerobic exercise capacity, bench press performance and clinical chemistry panels in recreationally active males.
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 |
|---|---|---|
| Creatine monohydrate | Experimental | Dietary Supplement: Creatine monohydrateCreatine monohydrate (6.0 g.) + dextrose (0.5 g.) |
| Creatine nitrate | Active comparator | Dietary Supplement: Creatine nitrateCreatine nitrate (5.0 g. creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo6.5 g. dextrose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participants are apparently healthy and recreationally active males between the ages of 18 and 40;
- participants 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)
- participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease;
- participants are currently using prescription medications;
- participants have a history of smoking;
- participants drink excessively (i.e., 12 drinks per week or more);
- participants 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 (6.0 g) + dextrose (0.5 g) | Dietary supplement | Creatine monohydrate |
| Creatine nitrateCreatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio) | Dietary supplement | Creatine nitrate |
| PlaceboPlacebo (6.5 g dextrose) | Dietary supplement | Placebo |
Primary outcome
Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water
Time frame: 28 Days
Assessing Body Water through Bioelectrical Impedance Analysis (BIA)
Effects of 28 Days of Different Forms of Creatine Supplementation on Body Composition
Time frame: 28 Days
Assessing Body Compositing through Dual-Energy X-Ray Absorptiometry (DXA)
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular creatine
Time frame: 28 Days
Assessing intramuscular creatine using standard spectrophotometric methods using a microplate spectrophotometer
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular phosphocreatine
Time frame: 28 Days
Assessing intramuscular phosphocreatine using standard spectrophotometric methods using a microplate spectrophotometer
Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular ATP
Time frame: 28 Days
Assessing intramuscular Adenosine Triphosphate (ATP) using standard spectrophotometric methods using a microplate spectrophotometer
Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength
Time frame: 28 Days
Assessing muscular strength through 1 Repetition Maximum (RM) testing
Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance
Time frame: 28 Days
Assessing muscular endurance through repetition to failure testing
Effects of 28 Days of Different Forms of Creatine Supplementation on anaerobic capacity
Time frame: 28 Days
Assessing anaerobic capacity through 6 x 6 second sprints followed by a 30 second sprint on a Wingate bicycle ergometer
3 secondary outcomes
Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)
Time frame: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects
Time frame: 28 Days
Effects of 28 Days of Different Forms of Creatine Supplementation on blood
Time frame: 28 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 4 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Dietary Supplementation
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Not yet recruiting
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
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 monohydrate and Creatine nitrate in people with Dietary Supplementation, 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 4 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 28 Days of Different Forms of Creatine Supplementation on Body Water (time frame: 28 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 4 Jan 2017.