Assessment of Different Forms of Creatine (NB3)

Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine

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

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Dietary supplement: Creatine monohydrate; Dietary supplement: Creatine nitrate-1; Dietary supplement: Creatine nitrate-2; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine monohydrate; 5 gm creatine monohydrate, 1.5 gm dextrose	Dietary supplement: Creatine monohydrate; Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)
Active Comparator: Creatine nitrate-1; 1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose	Dietary supplement: Creatine nitrate-1; Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)
Active Comparator: Creatine nitrate-2; 2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose	Dietary supplement: Creatine nitrate-2; Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)
Placebo Comparator: Placebo; 6.5 gm dextrose	Dietary supplement: Placebo; Placebo (6.5 g dextrose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Examine creatine vs. creatine nitrate supplementation by assessing body water	One day
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrabolt

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-0362F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No