Clinical Trial: Delivra Topical Creatine for Improving Muscular Power
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized, Double-blind, Placebo-controlled, Short Term Trial of DelivraTM Livsport Preworkout Cream for Improved Power Output and Reduction of Muscle Fatigue During Resistant Training
Brief 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 Summary:
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 eith
Sponsor: University of Saskatchewan
Current Primary Outcome: Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer [ Time Frame: Change from baseline to one week (i.e. after application of creatine cream) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse events recorded on adverse event forms [ Time Frame: Changes from baseline to one week (i.e. after application of creatine cream) ]
- Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer [ Time Frame: Change from baseline to one week (i.e. after application of creatine cream) ]
Original Secondary Outcome: Same as current
Information By: University of Saskatchewan
Dates:
Date Received: October 30, 2016
Date Started: October 2016
Date Completion: November 2017
Last Updated: December 27, 2016
Last Verified: November 2016
