Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
Primary Purpose
Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3.5 mL/d topical creatine
3.5 mL/d topical placebo
21 g/d Oral creatine
21 g/d oral placebo
Sponsored by
About this trial
This is an interventional treatment 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
Placebo Comparator
Arm Label
Oral creatine supplementation
Oral placebo supplementation
Arm Description
21 g/d oral creatine for 7 days
21 g/d oral placebo for 7 days
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
Change in body composition (percent fat)
Change in body water content
Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Adverse events recorded on adverse event forms
Full Information
NCT ID
NCT03006861
First Posted
December 27, 2016
Last Updated
June 27, 2018
Sponsor
University of Saskatchewan
Collaborators
University of Guelph, University of Prince Edward Island
1. Study Identification
Unique Protocol Identification Number
NCT03006861
Brief Title
Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
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 Resistant Training
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
University of Guelph, University of Prince Edward Island
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 whether 7 days of topical creatine application is additive to orally-ingested creatine for improving 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.
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.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral creatine supplementation
Arm Type
Experimental
Arm Description
21 g/d oral creatine for 7 days
Arm Title
Oral placebo supplementation
Arm Type
Placebo Comparator
Arm Description
21 g/d oral placebo for 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
3.5 mL/d topical creatine
Intervention Type
Dietary Supplement
Intervention Name(s)
3.5 mL/d topical placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
21 g/d Oral creatine
Intervention Type
Dietary Supplement
Intervention Name(s)
21 g/d oral 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 7 days
Secondary Outcome Measure Information:
Title
Change in body composition (percent fat)
Time Frame
Change from baseline to 7 days
Title
Change in body water content
Time Frame
Change from baseline to 7 days
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 7 days
Title
Adverse events recorded on adverse event forms
Time Frame
Change from baseline to 7 days
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
Philip Chilibeck, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamie Burr, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Travis Saunders, PhD
Organizational Affiliation
University of Prince Edward Island
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 Combined With Oral Creatine for Improving Muscular Power
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