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Assessment of Different Forms of Creatine

NCT ID: NCT03000582

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Creatine monohydrate

5 gm creatine monohydrate, 1.5 gm dextrose

Group Type EXPERIMENTAL

Creatine monohydrate

Intervention Type DIETARY_SUPPLEMENT

Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)

Creatine nitrate-1

1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose

Group Type ACTIVE_COMPARATOR

Creatine nitrate-1

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)

Creatine nitrate-2

2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose

Group Type ACTIVE_COMPARATOR

Creatine nitrate-2

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)

Placebo

6.5 gm dextrose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (6.5 g dextrose)

Interventions

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Creatine monohydrate

Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate-1

Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate-2

Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (6.5 g dextrose)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Eligible Sex

Accepts Healthy Volunteers

Yes

Sponsors

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Nutrabolt

INDUSTRY

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IRB2014-0362F

Identifier Type: -

Identifier Source: org_study_id