Safety of Different Forms of Creatine

NCT ID: NCT03039829

Last Updated: 2017-02-01

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

Brief Summary

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This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.

Detailed Description

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This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.

Conditions

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Nutritional Supplements

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 nitrate, low dose

Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)

Group Type EXPERIMENTAL

Creatine nitrate, low dose

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)

Creatine nitrate, high dose

Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)

Group Type ACTIVE_COMPARATOR

Creatine nitrate, high dose

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)

Placebo

Placebo at 6.0 grams dextrose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo at 6.0 grams (6.0 grams dextrose)

Interventions

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Creatine nitrate, low dose

Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)

Intervention Type DIETARY_SUPPLEMENT

Creatine nitrate, high dose

Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo at 6.0 grams (6.0 grams dextrose)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy
* At least 6 months immediate prior history of resistance training including bench press and leg press or squat

Exclusion Criteria

* A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Use of prescription medication (birth control is allowed)
* Pregnant or nursing or plan to become pregnant during the next month
* Creatine or nitrate use in the last eight weeks
* History of smoking
* History of drinking (i.e., 12 drinks per week or more)
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

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

Principal Investigators

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Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Other Identifiers

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IRB2015-0684

Identifier Type: -

Identifier Source: org_study_id

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