Physiological Effects of Creatine Supplementation in Active Males

Dietary Supplementation Clinical Trial

— NB4  

Official title:

Effects of 28 Days of Different Forms of Creatine Supplementation on Muscle Creatine, Body Composition and Exercise Performance in Recreationally Active Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003988
• Other study ID #: IRB2014-0503FX
• Status: Completed
• Phase: N/A
• First received: December 14, 2016
• Last updated: January 2, 2017
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study examined the effects of different formulations of creatine nitrate on muscle creatine content, body composition, anaerobic exercise capacity, bench press performance and clinical chemistry panels in recreationally active males.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dietary Supplementation

Intervention

Dietary Supplement:
• Creatine monohydrate
Creatine monohydrate (6.0 g) + dextrose (0.5 g)
• Creatine nitrate
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)
• Placebo
Placebo (6.5 g dextrose)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Nutrabolt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of 28 Days of Different Forms of Creatine Supplementation on Body Water	Assessing Body Water through Bioelectrical Impedance Analysis (BIA)	28 Days	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Effects of 28 Days of Different Forms of Creatine Supplementation on muscular strength	Assessing muscular strength through 1 Repetition Maximum (RM) testing	28 Days	No
Primary	Effects of 28 Days of Different Forms of Creatine Supplementation on muscular endurance	Assessing muscular endurance through repetition to failure testing	28 Days	No
Primary	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	No
Secondary	Effects of 28 Days of Different Forms of Creatine Supplementation on training volume (weight lifted x number of repetitions x number of sets)	Assessing training volume using a calculator	28 Days	No
Secondary	Effects of 28 Days of Different Forms of Creatine Supplementation on self-reported side effects	Assessing self-reported side effects using a side effects questionnaire	28 Days	Yes
Secondary	Effects of 28 Days of Different Forms of Creatine Supplementation on blood	Measure standard clinical chemistry panels in the blood to evaluate safety	28 Days	Yes