Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power

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).

Study Overview

• Status: Completed
• Conditions: Muscle Weakness
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 2W1
      • University of Guelph
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 4P3
      • University of Prince Edward Island
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5B2
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral creatine supplementation; 21 g/d oral creatine for 7 days	Dietary supplement: 3.5 mL/d topical creatine; Dietary supplement: 3.5 mL/d topical placebo; Dietary supplement: 21 g/d Oral creatine
Placebo Comparator: Oral placebo supplementation; 21 g/d oral placebo for 7 days	Dietary supplement: 3.5 mL/d topical creatine; Dietary supplement: 3.5 mL/d topical placebo; Dietary supplement: 21 g/d oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: University of Guelph; University of Prince Edward Island
• Investigators: Principal Investigator: Jamie Burr, PhD, University of Guelph; Principal Investigator: Travis Saunders, PHD, University of Prince Edward Island

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 16-145b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No