Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 8:26 AM
Study NCT ID:
NCT03006861
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2016-12-27', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer', 'timeFrame': 'Change from baseline to 7 days'}], 'secondaryOutcomes': [{'measure': 'Change in body composition (percent fat)', 'timeFrame': 'Change from baseline to 7 days'}, {'measure': 'Change in body water content', 'timeFrame': 'Change from baseline to 7 days'}, {'measure': 'Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer', 'timeFrame': 'Change from baseline to 7 days'}, {'measure': 'Adverse events recorded on adverse event forms', 'timeFrame': 'Change from baseline to 7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscle Weakness']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nTraditionally, 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.\n\nThe hypothesis is that topically-applied creatine is additive with orally-ingested creatine for improving muscular performance.\n\nThe 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.\n\nThe 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.\n\nThe primary outcomes are average and peak power output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically active and able to pass Physical Activity Readiness Questionnaire\n\nExclusion Criteria:\n\n* Allergies to any ingredients in the cream\n* Answering "yes" to Physical Activity Readiness Questionnaire\n* Currently pregnant or breastfeeding,\n* Presence of significant medical disorder that would compromise the participant\'s safety to take part in the trial (eg: cancer, immunosuppressed)\n* History of alcohol or drug abuse within the past year\n* Anyone using recreational drugs\n* Use of performance enhancing drugs or supplements within 2 months including caffeine and creatine in supplement form\n* Currently using other topical agents for treatment of pain or inflammation'}, 'identificationModule': {'nctId': 'NCT03006861', 'briefTitle': 'Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '16-145b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral creatine supplementation', 'description': '21 g/d oral creatine for 7 days', 'interventionNames': ['Dietary Supplement: 3.5 mL/d topical creatine', 'Dietary Supplement: 3.5 mL/d topical placebo', 'Dietary Supplement: 21 g/d Oral creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral placebo supplementation', 'description': '21 g/d oral placebo for 7 days', 'interventionNames': ['Dietary Supplement: 3.5 mL/d topical creatine', 'Dietary Supplement: 3.5 mL/d topical placebo', 'Dietary Supplement: 21 g/d oral placebo']}], 'interventions': [{'name': '3.5 mL/d topical creatine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oral creatine supplementation', 'Oral placebo supplementation']}, {'name': '3.5 mL/d topical placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oral creatine supplementation', 'Oral placebo supplementation']}, {'name': '21 g/d Oral creatine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oral creatine supplementation']}, {'name': '21 g/d oral placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oral placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Guelph', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'C1A 4P3', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'University of Prince Edward Island', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'S7N 5B2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Philip Chilibeck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}, {'name': 'Jamie Burr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}, {'name': 'Travis Saunders, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Prince Edward Island'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Guelph', 'class': 'OTHER'}, {'name': 'University of Prince Edward Island', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}