NCT Number: NCT03006861
Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
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).
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Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Guelph, Guelph, Ontario, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Physically active and able to pass Physical Activity Readiness Questionnaire
Exclusion criteria
- 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
Treatment and study plan
3.5 mL/d topical placebo
Dietary Supplement21 g/d Oral creatine
Dietary Supplement21 g/d oral placebo
Dietary SupplementPrimary outcomes
-
Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Time frame: Change from baseline to 7 days
Secondary outcomes
-
Change in body composition (percent fat)
Time frame: Change from baseline to 7 days
-
Change in body water content
Time frame: Change from baseline to 7 days
-
Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Time frame: Change from baseline to 7 days
-
Adverse events recorded on adverse event forms
Time frame: Change from baseline to 7 days
Sponsors and collaborators
Lead sponsor
University of Saskatchewan
Other
Collaborators
- University of Guelph
- University of Prince Edward Island
Registry information
Official study title
Randomized, Double-blind, Placebo-controlled, Short Term Trial of DelivraTM Livsport Preworkout Cream With or Without Oral Creatine for Improved Power Output and Reduction of Muscle Fatigue During Resistant Training
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Dec 30, 2016
- Registry last updated
- Jun 28, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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