Safety of Different Forms of Creatine (NB9)

Texas A&M University

Status: Completed

Conditions: Nutritional Supplements

Treatments: Dietary Supplement: Creatine nitrate, high dose; Dietary Supplement: Placebo; Dietary Supplement: Creatine nitrate, low dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03039829

IRB2015-0684

Details and patient eligibility

About

This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 3 patient groups, including a placebo group

Creatine nitrate, low dose

Experimental group

Description:

Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)

Treatment:

Dietary Supplement: Creatine nitrate, low dose

Creatine nitrate, high dose

Active Comparator group

Description:

Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)

Treatment:

Dietary Supplement: Creatine nitrate, high dose

Placebo

Placebo Comparator group

Description:

Placebo at 6.0 grams dextrose

Treatment:

Dietary Supplement: Placebo