NCT02960425

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 the acute application of two different doses of the creatine cream on 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
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

October 30, 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 one week (i.e. after application of creatine cream)

Secondary Outcomes (2)

  • Adverse events recorded on adverse event forms

    Changes from baseline to one week (i.e. after application of creatine cream)

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

    Change from baseline to one week (i.e. after application of creatine cream)

Study Arms (2)

HI Delivra TM Livsport preworkout cream

EXPERIMENTAL

7 mL topical creatine cream

Dietary Supplement: Delivra TM Livsport preworkout creamDietary Supplement: Placebo

LO Delivra TM Livsport preworkout cream

EXPERIMENTAL

3.5 mL topical creatine + 3.5 mL placebo cream

Dietary Supplement: Delivra TM Livsport preworkout creamDietary Supplement: Placebo

Interventions

Delivra TM Livsport preworkout creamDIETARY_SUPPLEMENT

High versus low dose topical creatine

HI Delivra TM Livsport preworkout creamLO Delivra TM Livsport preworkout cream
PlaceboDIETARY_SUPPLEMENT

Topical placebo

HI Delivra TM Livsport preworkout creamLO Delivra TM Livsport preworkout cream

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Baranowski, Ph.D.

    Delivra, Inc.

    STUDY DIRECTOR

  • Philip Chilibeck, Ph.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Jamie Burr, Ph.D.

    University of Guelph

    PRINCIPAL INVESTIGATOR

  • Travis Saunders, Ph.D.

    UPEI

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2016

First Posted

November 9, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)