Assessment of Different Forms of Creatine (NB3)

Texas A&M University

Status: Completed

Conditions: Dietary Modification

Treatments: Dietary Supplement: Creatine monohydrate; Dietary Supplement: Creatine nitrate-1; Dietary Supplement: Placebo; Dietary Supplement: Creatine nitrate-2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03000582

IRB2014-0362F

Details and patient eligibility

About

The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.

Full description

Creatine nitrate contains several nutrients that may increase anaerobic exercise performance. Theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. Diet, physical activity and pharmaceutical interventions can all impact vascular function and health. The purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on FMD by analyzing the pharmacokinetics of creatine nitrate supplementation.

Enrollment: 13 patients

Sex

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• you are an apparently healthy and recreationally active male between the ages of 18 and 40;

Exclusion criteria

• you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmia and/or cardiovascular disease;
• you are currently using prescription medications;
• you have a history of smoking;
• you drink excessively (i.e., 12 drinks per week or more);
• you have a recent history of creatine supplementation within six weeks of the start of supplementation;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 4 patient groups, including a placebo group

Creatine monohydrate

Experimental group

Description:

5 gm creatine monohydrate, 1.5 gm dextrose

Treatment:

Dietary Supplement: Creatine monohydrate

Creatine nitrate-1

Active Comparator group

Description:

1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose

Treatment:

Dietary Supplement: Creatine nitrate-1

Creatine nitrate-2

Active Comparator group

Description:

2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose

Treatment:

Dietary Supplement: Creatine nitrate-2

Placebo

Placebo Comparator group

Description:

6.5 gm dextrose

Treatment:

Dietary Supplement: Placebo