Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Muscle Weakness

Intervention / Treatment
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* Dietary Supplement: 3.5 mL/d topical creatine
* Dietary Supplement: 3.5 mL/d topical placebo
* Dietary Supplement: 21 g/d Oral creatine
* Dietary Supplement: 21 g/d oral placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physically active and able to pass Physical Activity Readiness Questionnaire Exclusion Criteria: Allergies to any ingredients in the cream Answering yes to Physical Activity Readiness Questionnaire Currently pregnant or breastfeeding, Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg: cancer, immunosuppressed) History of alcohol or drug abuse within the past year Anyone using recreational drugs Use of performance enhancing drugs or supplements within 2 months including caffeine and creatine in supplement form Currently using other topical agents for treatment of pain or inflammation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral creatine supplementation<br>21 g/d oral creatine for 7 days | Dietary Supplement: 3.5 mL/d topical creatine<br> <br> Dietary Supplement: 3.5 mL/d topical placebo<br> <br> Dietary Supplement: 21 g/d Oral creatine<br> <br> |
| Placebo Comparator: Oral placebo supplementation<br>21 g/d oral placebo for 7 days | Dietary Supplement: 3.5 mL/d topical creatine<br> <br> Dietary Supplement: 3.5 mL/d topical placebo<br> <br> Dietary Supplement: 21 g/d oral placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer |  | Change from baseline to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition (percent fat) |  | Change from baseline to 7 days | 
| Change in body water content |  | Change from baseline to 7 days | 
| Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer |  | Change from baseline to 7 days | 
| Adverse events recorded on adverse event forms |  | Change from baseline to 7 days |