Safety of Different Forms of Creatine
NB9
Short-Term Safety and Dose Effects of Different Forms of Creatine
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedFebruary 1, 2017
January 1, 2017
4 months
January 20, 2017
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Measuring the blood pressure response to creatine nitrate ingestion
7 days
Measuring the heart rate response to creatine nitrate ingestion
7 days
Secondary Outcomes (4)
Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
7 days
Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
7 days
Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
7 days
Measuring self-reported side effects of creatine nitrate ingestion
7 days
Study Arms (3)
Creatine nitrate, low dose
EXPERIMENTALCreatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)
Creatine nitrate, high dose
ACTIVE COMPARATORCreatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)
Placebo
PLACEBO COMPARATORPlacebo at 6.0 grams dextrose
Interventions
Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
Eligibility Criteria
You may qualify if:
- Apparently healthy
- At least 6 months immediate prior history of resistance training including bench press and leg press or squat
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas A&M Universitylead
- Nutraboltcollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Richard B Kreider, PhD
Texas A&M University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
February 1, 2017
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share