Clinical trial NCT03006861: Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: University of Guelph
name: University of Prince Edward Island
First posted: 2016-12-30
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
timeFrame: Change from baseline to 7 days
Secondary outcomes:
measure: Change in body composition (percent fat)
timeFrame: Change from baseline to 7 days
measure: Change in body water content
timeFrame: Change from baseline to 7 days
measure: Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
timeFrame: Change from baseline to 7 days
measure: Adverse events recorded on adverse event forms
timeFrame: Change from baseline to 7 days
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
city: Charlottetown
country: Canada
facility: University of Prince Edward Island
state: Prince Edward Island
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Guelph
name: Jamie Burr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Prince Edward Island
name: Travis Saunders, PhD
role: PRINCIPAL_INVESTIGATOR
References: