Delivra Topical Creatine Combined With Oral 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 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.
    

Intervention name(s): 3.5 mL/d topical creatine; 3.5 mL/d topical placebo; 21 g/d Oral creatine; 21 g/d oral placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment