Delivra Topical Creatine for Improving Muscular Power
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

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 the acute application of two different doses of the creatine
      cream on 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.

      Delivra Inc. has developed a topical cream containing creatine that is designed to penetrate
      the skin. The study purpose is to determine whether the topical cream, at two different
      doses, is effective for improving muscular strength and power.

      The hypotheses are that the experimental topical creatine cream will be more effective than a
      placebo cream for improving muscular performance and that two consecutive applications of
      creatine cream is more effective than a single application for improving muscular
      performance.

      The study involves a involves a double-blind placebo-controlled parallel group design.
      Participants (n=132) will be randomized to receive either a low dose (3.5 mL) or high dose (7
      mL) of topical creatine.

      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. At least 72 hours after the baseline testing, participants will receive
      either a high or low dose of the topical creatine cream applied to the quadriceps of one leg.
      The high-dose group will receive 3.5 mL of creatine cream 30 minutes and 15 minutes to one
      leg (randomized) before exercise testing (i.e. the same testing as performed in visit 2).
      They will receive 3.5 mL of placebo cream 30 and 15 minutes to the opposite leg before
      testing. The low-dose group will receive placebo cream 30 minutes before testing and creatine
      cream 15 minutes before testing to one leg; they will receive placebo cream 30 and 15 minutes
      before testing on the opposite leg. Testing on each leg will involve measuring muscular power
      during 5 sets of 15 repetitions of knee extension on the dynamometer, with each set separated
      by 1 minute rest.

      The primary outcomes are average and peak power output.
    

Intervention name(s): Delivra TM Livsport preworkout cream; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High versus low dose topical creatine; Topical placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other