Assessment of Different Forms of Creatine

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: Creatine monohydrate; Dietary Supplement: Creatine nitrate-1; Dietary Supplement: Creatine nitrate-2; Dietary Supplement: Placebo

• Registration Number: NCT03000582
• Lead Sponsor: Texas A&M University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-22
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 13

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Creatine monohydrate	Creatine monohydrate	5 gm creatine monohydrate, 1.5 gm dextrose
Creatine nitrate-1	Creatine nitrate-1	1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose
Creatine nitrate-2	Creatine nitrate-2	2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose
Placebo	Placebo	6.5 gm dextrose

Primary Outcome Measures

Name	Time	Method
Examine creatine vs. creatine nitrate supplementation by assessing body composition	One day
Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels	One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels	One day
Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels	One day
Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography	One day
Examine creatine vs. creatine nitrate supplementation by assessing body water	One day

Secondary Outcome Measures

Name	Time	Method
Measure standard clinical chemistry panels in the blood to evaluate safety	One day
Measure side effects to evaluate safety utilizing a side effects questionnaire	One day
Measure heart rate to evaluate safety	One day
Measure blood pressure to evaluate safety	One day