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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006861
Other study ID # 16-145b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date October 2017

Study information

Verified date June 2018
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 129
Est. completion date October 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
3.5 mL/d topical creatine

3.5 mL/d topical placebo

21 g/d Oral creatine

21 g/d oral placebo


Locations

Country Name City State
Canada University of Prince Edward Island Charlottetown Prince Edward Island
Canada University of Guelph Guelph Ontario
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (3)

Lead Sponsor Collaborator
University of Saskatchewan University of Guelph, University of Prince Edward Island

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in body composition (percent fat) Change from baseline to 7 days
Secondary Change in body water content Change from baseline to 7 days
Secondary Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer Change from baseline to 7 days
Secondary Adverse events recorded on adverse event forms Change from baseline to 7 days
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