Clinical Trial: Delivra Topical Creatine Combined With Oral 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 With or Without Oral Creatine for Improved Power Output and Reduction of Muscle Fatigue During Res
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 whether 7 days of topical creatine application is additive to orally-ingested creatine for improving 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.
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 assessmen
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 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in body composition (percent fat) [ Time Frame: Change from baseline to 7 days ]
- Change in body water content [ Time Frame: Change from baseline to 7 days ]
- 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 ]
- Adverse events recorded on adverse event forms [ Time Frame: Change from baseline to 7 days ]
Original Secondary Outcome: Same as current
Information By: University of Saskatchewan
Dates:
Date Received: December 27, 2016
Date Started: December 2016
Date Completion: May 2017
Last Updated: December 27, 2016
Last Verified: December 2016
