Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT03510806
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2018-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Supplements for Exercise Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-exercise muscle soreness', 'timeFrame': '7 days', 'description': 'VAS score'}], 'secondaryOutcomes': [{'measure': 'post-exercise muscle strength', 'timeFrame': '7 days', 'description': 'countermovement jump performance'}, {'measure': 'post-exercise muscle function', 'timeFrame': '7 days', 'description': 'repetitive countermovement jumps'}, {'measure': 'satiety', 'timeFrame': '4-5 hours', 'description': 'VAS scores'}, {'measure': 'sleep quality', 'timeFrame': '15 days', 'description': 'sleep metrics, Fitbit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-exercise Muscle Soreness']}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to consume supplement\n* Willing to adhere to the study intervention regimen\n* Willing to abstain from analgesics for duration of the study\n* Agreement to adhere to Lifestyle Considerations\n\nExclusion Criteria:\n\n* Current use of NSAIDs\n* Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes\n* Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions\n* Weight \\> 350 pounds\n* Pregnancy or lactation\n* Known food allergies or sensitivities or dietary restrictions\n* Habitual consumption of \\> 2 alcoholic drinks per day\n* Febrile illness or antibiotic use within 1 month prior to baseline testing\n* Treatment with another investigational drug or other intervention within 1 month\n* Current smoker or tobacco use within 1 month\n* Any condition(s) or diagnosis, both physical or psychological, that, in the opinion of the principal investigator or study physician, precludes participation and/or ability to consent\n* Any other factor that, in the opinion of the principal investigator or study physician, would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study"}, 'identificationModule': {'nctId': 'NCT03510806', 'briefTitle': 'Nutritional Supplements for Exercise Recovery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beachbody'}, 'officialTitle': 'Evaluation of Nutritional Supplements for Exercise Recovery', 'orgStudyIdInfo': {'id': '03132018BB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'taste, color, and calorie-matched to supplement', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Supplement', 'description': 'Proprietary protein and fruit extract blend', 'interventionNames': ['Dietary Supplement: Supplement']}], 'interventions': [{'name': 'Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dietary supplement contain protein from milk and fruit extract', 'armGroupLabels': ['Supplement']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'color, taste, and calorie-matched placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90245', 'city': 'El Segundo', 'state': 'California', 'country': 'United States', 'facility': 'Beachbody', 'geoPoint': {'lat': 33.91918, 'lon': -118.41647}}], 'overallOfficials': [{'name': 'Catherine R Mikus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beachbody, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catherine Mikus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Catherine Mikus', 'investigatorAffiliation': 'Beachbody'}}}}