Physiological Effects of Creatine Supplementation in Active Males

NCT03003988 | Completed DMC

• 1 other identifier: IRB2014-0503FX
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to examine how different forms of creatine impact active males.

Conditions

Dietary Supplementation

Outcome Measures

Primary Outcomes (8)

• Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water

  Assessing Body Water through Bioelectrical Impedance Analysis (BIA)

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on Body Composition

  Assessing Body Compositing through Dual-Energy X-Ray Absorptiometry (DXA)

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular creatine

  Assessing intramuscular creatine using standard spectrophotometric methods using a microplate spectrophotometer

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular phosphocreatine

  Assessing intramuscular phosphocreatine using standard spectrophotometric methods using a microplate spectrophotometer

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on intramuscular ATP

  Assessing intramuscular Adenosine Triphosphate (ATP) using standard spectrophotometric methods using a microplate spectrophotometer

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength

  Assessing muscular strength through 1 Repetition Maximum (RM) testing

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance

  Assessing muscular endurance through repetition to failure testing

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on anaerobic capacity

  Assessing anaerobic capacity through 6 x 6 second sprints followed by a 30 second sprint on a Wingate bicycle ergometer

  28 Days

Secondary Outcomes (3)

• Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects

  28 Days

• Effects of 28 Days of Different Forms of Creatine Supplementation on blood

  28 Days

Study Arms (3)

Creatine monohydrate

EXPERIMENTAL

Creatine monohydrate (6.0 g.) + dextrose (0.5 g.)

Dietary Supplement: Creatine monohydrate

Creatine nitrate

ACTIVE COMPARATOR

Creatine nitrate (5.0 g. creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio).

Dietary Supplement: Creatine nitrate

Placebo

PLACEBO COMPARATOR

6.5 g. dextrose

Dietary Supplement: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

Creatine monohydrate (6.0 g) + dextrose (0.5 g)

Creatine monohydrate

Creatine nitrate DIETARY_SUPPLEMENT

Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio)

Creatine nitrate

Placebo DIETARY_SUPPLEMENT

Placebo (6.5 g dextrose)

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• participants are apparently healthy and recreationally active males between the ages of 18 and 40;
• participants will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;

You may not qualify if:

• participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease;
• participants are currently using prescription medications;
• participants have a history of smoking;
• participants drink excessively (i.e., 12 drinks per week or more);
• participants 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 Officials

• Richard B Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 28, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share