Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power

NCT ID: NCT03006861

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-10-31

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.

Conditions

Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral creatine supplementation

21 g/d oral creatine for 7 days

Group Type: EXPERIMENTAL

3.5 mL/d topical creatine

Intervention Type: DIETARY_SUPPLEMENT

3.5 mL/d topical placebo

Intervention Type: DIETARY_SUPPLEMENT

21 g/d Oral creatine

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo supplementation

21 g/d oral placebo for 7 days

Group Type: PLACEBO_COMPARATOR

3.5 mL/d topical creatine

Intervention Type: DIETARY_SUPPLEMENT

3.5 mL/d topical placebo

Intervention Type: DIETARY_SUPPLEMENT

21 g/d oral placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

3.5 mL/d topical creatine

Intervention Type: DIETARY_SUPPLEMENT

3.5 mL/d topical placebo

Intervention Type: DIETARY_SUPPLEMENT

21 g/d Oral creatine

Intervention Type: DIETARY_SUPPLEMENT

21 g/d oral placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guelph

OTHER

Sponsor Role: collaborator

University of Prince Edward Island

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Phil Chilibeck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Jamie Burr, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Travis Saunders, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Prince Edward Island

Locations

University of Guelph

Guelph, Ontario, Canada

University of Prince Edward Island

Charlottetown, Prince Edward Island, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

16-145b

Identifier Type: -

Identifier Source: org_study_id