Physiological Effects of Creatine Supplementation in Active Males (NB4)

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

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

Study Overview

• Status: Completed
• Conditions: Dietary Supplementation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Creatine monohydrate; Dietary supplement: Creatine nitrate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine monohydrate; Creatine monohydrate (6.0 g.) + dextrose (0.5 g.)	Dietary supplement: Creatine monohydrate; Creatine monohydrate (6.0 g) + dextrose (0.5 g)
Active Comparator: 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).	Dietary supplement: 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 Comparator: Placebo; 6.5 g. dextrose	Dietary supplement: Placebo; Placebo (6.5 g dextrose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrabolt
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-0503FX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No