Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT06102460
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2023-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-sleep Macros on Sleep Quality and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Neither the participant or investigator will know what treatment has been given until un-blinding at the completion of the study.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants will complete all 4 interventions with at least a 1 week wash out period in between.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep', 'timeFrame': 'Data obtained from device 12 hours after ingestion of supplement', 'description': 'Sleep score determined by WHOOP 4.0 wearable device'}, {'measure': 'Recovery', 'timeFrame': 'Data obtained from device 12 hours after ingestion of supplement', 'description': 'Recovery score determined by WHOOP 4.0 wearable device'}], 'secondaryOutcomes': [{'measure': 'Subjective sleep score', 'timeFrame': 'Data obtained 1-2 hours after after subject awakes', 'description': 'Subjective sleep score obtained from questionnaire'}, {'measure': 'Subjective recovery score', 'timeFrame': 'Data obtained 1-2 hours after after subject awakes', 'description': 'Subjective sleep score obtained from questionnaire'}, {'measure': 'Blood glucose control', 'timeFrame': 'Continuous (24hours/day) during intervention days/nights', 'description': 'Using the continuous glucose monitor, participants blood glucose response throughout the day and night relative to regular meals and intervention will be observed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the effect of eating before bed (2 hours after dinner, 30mins before bed) and the effects this has on sleep and recovery measures in elite female athletes.\n\nParticipants will be randomized to 4 possible groups in a double-blind randomized cross over design. Each group will ingest 40 grams of one of the following nutrients as a liquid shake for 3 consecutive nights:\n\n1. Casein Protein\n2. a-lactalbumin Protein\n3. Carbohydrate\n4. Placebo\n\nThere will be at least 1 week washout period between each intervention.\n\nSleep and recovery outcome measures will be obtained through a WHOOP 4.0 wearable healthy tracking device. Subjective sleep and recovery will be obtained through subjective questionnaires. Food will be logged by participants on intervention days. Blood glucose will be measured using continuous glucose monitors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NCAA Division I female athlete\n* Wearing WHOOP 4.0 device for \\>3 months\n\nExclusion Criteria:\n\n* Musculoskeletal injuries limiting participation in regular team practice.\n* Cardiometabolic diseases limiting participation in regular team practice.\n* Pre-diagnosed sleep condition that would negatively affect sleep quality or quantity (sleep apnea, restless leg syndrome, night-feeding syndrome)\n* Allergy to any dietary supplement used in protocol - e.g., lactose intolerant.\n* Use of sleep aids such as but not limited to, melatonin.'}, 'identificationModule': {'nctId': 'NCT06102460', 'briefTitle': 'Pre-sleep Macros on Sleep Quality and Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'The Effect of Pre-sleep Milk-derived Protein to Support Sleep Quality and Recovery in Elite Female Athletes', 'orgStudyIdInfo': {'id': 'STUDY00004409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Casein Protein', 'description': 'Each participant will consume a serving of casein protein mix.', 'interventionNames': ['Dietary Supplement: Casein protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'a-lactalbumin', 'description': 'Each participant will consume a serving of a-lactalbumin protein mix.', 'interventionNames': ['Dietary Supplement: a-lactalbumin protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate', 'description': 'Each participant will consume a serving of carbohydrate mix.', 'interventionNames': ['Dietary Supplement: Carbohydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each participant will consume a serving of a placebo mix.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Casein protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '40 grams of casein protein powder mixed with 8-10 fl. oz. of water.', 'armGroupLabels': ['Casein Protein']}, {'name': 'a-lactalbumin protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.', 'armGroupLabels': ['a-lactalbumin']}, {'name': 'Carbohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': '40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.', 'armGroupLabels': ['Carbohydrate']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32303', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Institute of Sports Sciences and Medicine - Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Milk Specialties Global', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Michael J. Ormsbee', 'investigatorAffiliation': 'Florida State University'}}}}