Safety of Different Forms of Creatine (NB9)

January 30, 2017 updated by: Texas A&M University

Short-Term Safety and Dose Effects of Different Forms of Creatine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creatine nitrate, low dose
Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose)
Dietary supplement: Creatine nitrate, low dose
Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
Active Comparator: Creatine nitrate, high dose
Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate)
Dietary supplement: Creatine nitrate, high dose
Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
Placebo Comparator: Placebo
Placebo at 6.0 grams dextrose
Dietary supplement: Placebo
Placebo at 6.0 grams (6.0 grams dextrose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring the blood pressure response to creatine nitrate ingestion
Time Frame: 7 days
7 days
Measuring the heart rate response to creatine nitrate ingestion
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
Time Frame: 7 days
7 days
Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
Time Frame: 7 days
7 days
Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
Time Frame: 7 days
7 days
Measuring self-reported side effects of creatine nitrate ingestion
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas A&M University

Collaborators

Nutrabolt

Investigators

  • Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB2015-0684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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