Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
- Conditions
- Muscle Weakness
- Interventions
- Dietary Supplement: 3.5 mL/d topical creatineDietary Supplement: 3.5 mL/d topical placeboDietary Supplement: 21 g/d Oral creatineDietary Supplement: 21 g/d oral placebo
- Registration Number
- NCT03006861
- Lead Sponsor
- University of Saskatchewan
- Brief Summary
Creatine is a nutritional supplement that is often ingested to improve exercise performance. The advent of a new product that is applied to the skin overlying muscle offers potential benefit, if the creatine can be targeted to specific muscles. The investigators are testing a novel creatine cream to determine the effects on human muscular performance. The investigators are assessing whether 7 days of topical creatine application is additive to orally-ingested creatine for improving muscular power (determined by knee extension).
- Detailed Description
Creatine monohydrate is a popular nutritional supplement with athletes involved in sports involving strength and power. When creatine is orally ingested it combines with inorganic phosphate to form phorylcreatine (PCr) in skeletal muscle . Adenosine Triphosphate (ATP) is the immediate source of energy in muscle - during exercise ATP is broken down to Adenosine Diphosphate (ADP) and inorganic phosphate. Duration of high-intensity exercise is limited to a few seconds based on limited ATP stores in muscle. PCr acts to re-phosphorylate ADP to form ATP so that muscle contraction can continue at high intensities. After creatine monohydrate is ingested, high-intensity exercise capacity is increased because of the increased PCr stores in muscle.
Traditionally, creatine is consumed orally as a supplement. Delivra Inc. has developed a topical cream containing creatine that is designed to penetrate the skin. The study purpose is to determine whether topically-applied creatine is additive with orally-ingested creatine for improving muscular strength and power.
The hypothesis is that topically-applied creatine is additive with orally-ingested creatine for improving muscular performance.
The study involves a double-blind placebo-controlled parallel group design. Participants (n=132) will be randomized to receive either oral creatine supplementation or placebo (21 g/d) for 7 days. One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the opposite leg placebo for 7 days.
The baseline assessment involves measuring muscular power during 5 sets of 15 repetitions of knee extension on a dynamometer, with each set separated by 1 minute rest, with each leg tested separately. Additional measures include assessment of body composition and body water content. Participants will then receive either oral creatine (21 g/d) or placebo for 7 days. One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the opposite leg placebo for 7 days. The same assessments as done at baseline will then be repeated after the 7 days of creatine supplementation.
The primary outcomes are average and peak power output.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Physically active and able to pass Physical Activity Readiness Questionnaire
- Allergies to any ingredients in the cream
- Answering "yes" to Physical Activity Readiness Questionnaire
- Currently pregnant or breastfeeding,
- Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg: cancer, immunosuppressed)
- History of alcohol or drug abuse within the past year
- Anyone using recreational drugs
- Use of performance enhancing drugs or supplements within 2 months including caffeine and creatine in supplement form
- Currently using other topical agents for treatment of pain or inflammation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Oral creatine supplementation 21 g/d Oral creatine 21 g/d oral creatine for 7 days Oral placebo supplementation 21 g/d oral placebo 21 g/d oral placebo for 7 days Oral creatine supplementation 3.5 mL/d topical placebo 21 g/d oral creatine for 7 days Oral placebo supplementation 3.5 mL/d topical placebo 21 g/d oral placebo for 7 days Oral placebo supplementation 3.5 mL/d topical creatine 21 g/d oral placebo for 7 days Oral creatine supplementation 3.5 mL/d topical creatine 21 g/d oral creatine for 7 days
- Primary Outcome Measures
Name Time Method Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer Change from baseline to 7 days
- Secondary Outcome Measures
Name Time Method Change in body composition (percent fat) Change from baseline to 7 days Change in body water content Change from baseline to 7 days Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer Change from baseline to 7 days Adverse events recorded on adverse event forms Change from baseline to 7 days
Trial Locations
- Locations (3)
University of Guelph
🇨🇦Guelph, Ontario, Canada
University of Prince Edward Island
🇨🇦Charlottetown, Prince Edward Island, Canada
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada