Assessment of Different Forms of Creatine (NB3)

• ClinicalTrials.gov Identifier: NCT03000582
• Recruitment Status: Completed
• First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Sponsor: Texas A&M University
• Collaborator: Nutrabolt
• Information provided by (Responsible Party): Texas A&M University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dietary Modification	Dietary Supplement: Creatine monohydrate; Dietary Supplement: Creatine nitrate-1; Dietary Supplement: Creatine nitrate-2; Dietary Supplement: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine
• Study Start Date: June 2014
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Examine creatine vs. creatine nitrate supplementation by assessing body water [ Time Frame: One day ]
2. Examine creatine vs. creatine nitrate supplementation by assessing body composition [ Time Frame: One day ]
3. Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels [ Time Frame: One day ]
4. Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels [ Time Frame: One day ]
5. Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels [ Time Frame: One day ]
6. Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography [ Time Frame: One day ]

Secondary Outcome Measures :

1. Measure standard clinical chemistry panels in the blood to evaluate safety [ Time Frame: One day ]
2. Measure side effects to evaluate safety utilizing a side effects questionnaire [ Time Frame: One day ]
3. Measure heart rate to evaluate safety [ Time Frame: One day ]
4. Measure blood pressure to evaluate safety [ Time Frame: One day ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Criteria

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;

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Texas A&M University
• ClinicalTrials.gov Identifier: NCT03000582
• Other Study ID Numbers: IRB2014-0362F
• First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No