Muscle Weakness Clinical Trial
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
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).
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.
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