Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power

University of Saskatchewan

Status: Completed

Conditions: Muscle Weakness

Treatments: Dietary Supplement: 21 g/d Oral creatine; Dietary Supplement: 3.5 mL/d topical placebo; Dietary Supplement: 3.5 mL/d topical creatine; Dietary Supplement: 21 g/d oral placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03006861

16-145b

Details and patient eligibility

About

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).

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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129 participants in 2 patient groups, including a placebo group

Oral creatine supplementation

Experimental group

Description:

21 g/d oral creatine for 7 days

Treatment:

Dietary Supplement: 21 g/d Oral creatine

Dietary Supplement: 3.5 mL/d topical creatine

Dietary Supplement: 3.5 mL/d topical placebo

Oral placebo supplementation

Placebo Comparator group

Description:

21 g/d oral placebo for 7 days

Treatment:

Dietary Supplement: 3.5 mL/d topical creatine

Dietary Supplement: 21 g/d oral placebo

Dietary Supplement: 3.5 mL/d topical placebo