Safety of Different Forms of Creatine

Not Applicable

Completed

• Conditions: Nutritional Supplements
• Interventions: Dietary Supplement: Creatine nitrate, low dose; Dietary Supplement: Creatine nitrate, high dose; Dietary Supplement: Placebo

• Registration Number: NCT03039829
• Lead Sponsor: Texas A&M University

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.

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-30
• Last Update Submitted: 2017-01-30
• Study First Posted: 2017-02-01
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Creatine nitrate, low dose	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, high dose	Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)
Placebo	Placebo	Placebo at 6.0 grams dextrose

Primary Outcome Measures

Name	Time	Method
Measuring the heart rate response to creatine nitrate ingestion	7 days
Measuring the blood pressure response to creatine nitrate ingestion	7 days

Secondary Outcome Measures

Name	Time	Method
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