Assessment of Different Forms of Creatine

Dietary Modification Clinical Trial

— NB3  

Official title:

Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000582
• Other study ID #: IRB2014-0362F
• Status: Completed
• Phase: N/A
• First received: December 14, 2016
• Last updated: December 19, 2016
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2016
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• Creatine monohydrate
Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)
• Creatine nitrate-1
Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)
• Creatine nitrate-2
Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)
• Placebo
Placebo (6.5 g dextrose)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Nutrabolt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine creatine vs. creatine nitrate supplementation by assessing body water		One day	No
Primary	Examine creatine vs. creatine nitrate supplementation by assessing body composition		One day	No
Primary	Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels		One day	No
Primary	Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels		One day	No
Primary	Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels		One day	No
Primary	Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography		One day	No
Secondary	Measure standard clinical chemistry panels in the blood to evaluate safety		One day	Yes
Secondary	Measure side effects to evaluate safety utilizing a side effects questionnaire		One day	Yes
Secondary	Measure heart rate to evaluate safety		One day	Yes
Secondary	Measure blood pressure to evaluate safety		One day	Yes