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Completed

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph, Guelph, Ontario, Canada

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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 creatine

Dietary Supplement

3.5 mL/d topical placebo

Dietary Supplement

21 g/d Oral creatine

Dietary Supplement

21 g/d oral placebo

Dietary Supplement

Primary outcomes

  1. 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

  1. Change in body composition (percent fat)

    Time frame: Change from baseline to 7 days

  2. Change in body water content

    Time frame: Change from baseline to 7 days

  3. 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

  4. 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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