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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03006861
Enrollment
129
Registered
2016-12-30
Start date
2016-12-31
Completion date
2017-10-31
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

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.

Interventions

DIETARY_SUPPLEMENT21 g/d Oral creatine
DIETARY_SUPPLEMENT21 g/d oral placebo
DIETARY_SUPPLEMENT3.5 mL/d topical creatine
DIETARY_SUPPLEMENT3.5 mL/d topical placebo

Sponsors

University of Guelph
CollaboratorOTHER
University of Prince Edward Island
CollaboratorOTHER
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometerChange from baseline to 7 days

Secondary

MeasureTime frame
Change in body composition (percent fat)Change from baseline to 7 days
Change in body water contentChange from baseline to 7 days
Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometerChange from baseline to 7 days
Adverse events recorded on adverse event formsChange from baseline to 7 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026