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Assessment of Different Forms of Creatine (NB3)

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

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.

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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

Resource links provided by the National Library of Medicine


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)




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 ]


Information from the National Library of Medicine

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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;
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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT03000582    
Other Study ID Numbers: IRB2014-0362F
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No