Assessment of Different Forms of Creatine

NCT03000582 | Completed DMC

• 1 other identifier: IRB2014-0362F
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (6)

• Examine creatine vs. creatine nitrate supplementation by assessing body water

  One day

• Examine creatine vs. creatine nitrate supplementation by assessing body composition

  One day

• Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels

  One day

• Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels

  One day

• Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels

  One day

• Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography

  One day

Secondary Outcomes (4)

• Measure standard clinical chemistry panels in the blood to evaluate safety

  One day

• Measure side effects to evaluate safety utilizing a side effects questionnaire

  One day

• Measure heart rate to evaluate safety

  One day

• Measure blood pressure to evaluate safety

  One day

Study Arms (4)

Creatine monohydrate

EXPERIMENTAL

5 gm creatine monohydrate, 1.5 gm dextrose

Dietary Supplement: Creatine monohydrate

Creatine nitrate-1

ACTIVE COMPARATOR

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

Dietary Supplement: Creatine nitrate-1

Creatine nitrate-2

ACTIVE COMPARATOR

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

Dietary Supplement: Creatine nitrate-2

Placebo

PLACEBO COMPARATOR

6.5 gm dextrose

Dietary Supplement: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

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

Creatine monohydrate

Creatine nitrate-1 DIETARY_SUPPLEMENT

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

Creatine nitrate-1

Creatine nitrate-2 DIETARY_SUPPLEMENT

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

Creatine nitrate-2

Placebo DIETARY_SUPPLEMENT

Placebo (6.5 g dextrose)

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• you are an apparently healthy and recreationally active male between the ages of 18 and 40;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Texas A&M University: lead
• Nutrabolt: collaborator

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 22, 2016
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 22, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share