Delivra Topical Creatine for Improving Muscular Power
Primary Purpose
Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Delivra TM Livsport preworkout cream
Placebo
Sponsored by
About this trial
This is an interventional other trial for Muscle Weakness
Eligibility Criteria
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
Sites / Locations
- University of Guelph
- University of Prince Edward Island
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HI Delivra TM Livsport preworkout cream
LO Delivra TM Livsport preworkout cream
Arm Description
7 mL topical creatine cream
3.5 mL topical creatine + 3.5 mL placebo cream
Outcomes
Primary Outcome Measures
Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Secondary Outcome Measures
Adverse events recorded on adverse event forms
Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Full Information
NCT ID
NCT02960425
First Posted
October 30, 2016
Last Updated
June 27, 2018
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT02960425
Brief Title
Delivra Topical Creatine for Improving Muscular Power
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 either a high or low dose of the topical creatine cream applied to the quadriceps of one leg. The high-dose group will receive 3.5 mL of creatine cream 30 minutes and 15 minutes to one leg (randomized) before exercise testing (i.e. the same testing as performed in visit 2). They will receive 3.5 mL of placebo cream 30 and 15 minutes to the opposite leg before testing. The low-dose group will receive placebo cream 30 minutes before testing and creatine cream 15 minutes before testing to one leg; they will receive placebo cream 30 and 15 minutes before testing on the opposite leg. Testing on each leg will involve measuring muscular power during 5 sets of 15 repetitions of knee extension on the dynamometer, with each set separated by 1 minute rest.
The primary outcomes are average and peak power output.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HI Delivra TM Livsport preworkout cream
Arm Type
Experimental
Arm Description
7 mL topical creatine cream
Arm Title
LO Delivra TM Livsport preworkout cream
Arm Type
Experimental
Arm Description
3.5 mL topical creatine + 3.5 mL placebo cream
Intervention Type
Dietary Supplement
Intervention Name(s)
Delivra TM Livsport preworkout cream
Intervention Description
High versus low dose topical creatine
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Topical placebo
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Adverse events recorded on adverse event forms
Time Frame
Changes from baseline to one week (i.e. after application of creatine cream)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Baranowski, Ph.D.
Organizational Affiliation
Delivra, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, Ph.D.
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamie Burr, Ph.D.
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Travis Saunders, Ph.D.
Organizational Affiliation
UPEI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
Facility Name
University of Prince Edward Island
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 4P3
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Delivra Topical Creatine for Improving Muscular Power
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