Safety of Different Forms of Creatine

Nutritional Supplements Clinical Trial

— NB9  

Official title:

Short-Term Safety and Dose Effects of Different Forms of Creatine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039829
• Other study ID #: IRB2015-0684
• Status: Completed
• Phase: N/A
• First received: January 20, 2017
• Last updated: January 30, 2017
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Apparently healthy

• At least 6 months immediate prior history of resistance training including bench press and leg press or squat

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Nutritional Supplements

Intervention

Dietary Supplement:
• Creatine nitrate, low dose
Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
• Creatine nitrate, high dose
Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
• Placebo
Placebo at 6.0 grams (6.0 grams dextrose)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Nutrabolt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the blood pressure response to creatine nitrate ingestion		7 days
Primary	Measuring the heart rate response to creatine nitrate ingestion		7 days
Secondary	Measuring a blood chemistry panel 15 response to creatine nitrate ingestion		7 days
Secondary	Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion		7 days
Secondary	Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion		7 days
Secondary	Measuring self-reported side effects of creatine nitrate ingestion		7 days