Muscle WeaknessNCT03006861
Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
A study testing 3.5 mL/d topical creatine and 21 g/d Oral creatine in people with Muscle Weakness, run by University of Saskatchewan at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- 3.5 mL/d topical creatine and 21 g/d Oral creatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active and able to pass Physical Activity Readiness Questionnaire
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Canada3 sites
University of Prince Edward Island
Charlottetown, Prince Edward Island, C1A 4P3
University of Guelph
Guelph, Ontario, N1G 2W1
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
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
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).
Read the 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
- Being tested
- 3.5 mL/d topical creatine, 3.5 mL/d topical placebo, 21 g/d Oral creatine, 21 g/d oral placebo
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.5 mL/d topical creatineDietary supplement
3.5 mL/d topical placeboDietary supplement
21 g/d Oral creatineDietary supplement
21 g/d oral placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Oral creatine supplementation | Experimental | 21 g/d oral creatine for 7 days Receives: Dietary Supplement: 3.5 mL/d topical creatine; Dietary Supplement: 3.5 mL/d topical placebo; Dietary Supplement: 21 g/d Oral creatine |
| Oral placebo supplementation | Placebo comparator | 21 g/d oral placebo for 7 days Receives: Dietary Supplement: 3.5 mL/d topical creatine; Dietary Supplement: 3.5 mL/d topical placebo; Dietary Supplement: 21 g/d oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Measured: Change from baseline to 7 days
Secondary outcomes (4)
Change in body composition (percent fat)
Measured: Change from baseline to 7 days
Change in body water content
Measured: Change from baseline to 7 days
Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
Measured: Change from baseline to 7 days
Adverse events recorded on adverse event forms
Measured: Change from baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guelph, University of Prince Edward Island
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, PhD, Principal investigator, University of SaskatchewanJamie Burr, PhD, Principal investigator, University of GuelphTravis Saunders, PhD, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006861
- Sponsor's protocol ID
- 16-145b
- Status last verified
- Jun 2018
- First submitted
- 27 Dec 2016
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03006861
- Acronym / sponsor ID
- 16-145b
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Guelph, University of Prince Edward Island
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral creatine supplementation | Experimental | Dietary Supplement: 3.5 mL/d topical creatine, Dietary Supplement: 3.5 mL/d topical placebo, Dietary Supplement: 21 g/d Oral creatine21 g/d oral creatine for 7 days |
| Oral placebo supplementation | Placebo comparator | Dietary Supplement: 3.5 mL/d topical creatine, Dietary Supplement: 3.5 mL/d topical placebo, Dietary Supplement: 21 g/d oral placebo21 g/d oral placebo for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically active and able to pass Physical Activity Readiness Questionnaire
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.5 mL/d topical creatine | Dietary supplement | Oral creatine supplementation, Oral placebo supplementation |
| 3.5 mL/d topical placebo | Dietary supplement | Oral creatine supplementation, Oral placebo supplementation |
| 21 g/d Oral creatine | Dietary supplement | Oral creatine supplementation |
| 21 g/d oral placebo | Dietary supplement | Oral placebo supplementation |
Primary outcome
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
4 secondary outcomes
Change in body composition (percent fat)
Time frame: Change from baseline to 7 days
Change in body water content
Time frame: Change from baseline to 7 days
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
Adverse events recorded on adverse event forms
Time frame: Change from baseline to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chilibeck, PhD principal investigator
University of Saskatchewan
Jamie Burr, PhD principal investigator
University of Guelph
Travis Saunders, PhD principal investigator
University of Prince Edward Island
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3.5 mL/d topical creatine and 21 g/d Oral creatine in people with Muscle Weakness, run by University of Saskatchewan at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.