NCT03006861

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

December 27, 2016

Last Update Submit

June 27, 2018

Conditions

Muscle Weakness

Outcome Measures

Primary Outcomes (1)

  • Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer

    Change from baseline to 7 days

Secondary Outcomes (4)

  • Change in body composition (percent fat)

    Change from baseline to 7 days

  • Change in body water content

    Change from baseline to 7 days

  • Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer

    Change from baseline to 7 days

  • Adverse events recorded on adverse event forms

    Change from baseline to 7 days

Study Arms (2)

Oral creatine supplementation

EXPERIMENTAL

21 g/d oral creatine for 7 days

Dietary Supplement: 3.5 mL/d topical creatineDietary Supplement: 3.5 mL/d topical placeboDietary Supplement: 21 g/d Oral creatine

Oral placebo supplementation

PLACEBO COMPARATOR

21 g/d oral placebo for 7 days

Dietary Supplement: 3.5 mL/d topical creatineDietary Supplement: 3.5 mL/d topical placeboDietary Supplement: 21 g/d oral placebo

Interventions

3.5 mL/d topical creatineDIETARY_SUPPLEMENT
Oral creatine supplementationOral placebo supplementation
3.5 mL/d topical placeboDIETARY_SUPPLEMENT
Oral creatine supplementationOral placebo supplementation
21 g/d Oral creatineDIETARY_SUPPLEMENT
Oral creatine supplementation
21 g/d oral placeboDIETARY_SUPPLEMENT
Oral placebo supplementation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active and able to pass Physical Activity Readiness Questionnaire

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

University of Prince Edward Island

Charlottetown, Prince Edward Island, C1A 4P3, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Creatine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Philip Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Jamie Burr, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

  • Travis Saunders, PhD

    University of Prince Edward Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

October 1, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)