Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT03250234
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carbohydrate Availability and microRNA Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lee.m.margolis.civ@mail.mil', 'phone': '508-206-2335', 'title': 'Dr. Lee Margolis', 'organization': 'USARIEM'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'description': 'Hamstring cramping', 'eventGroups': [{'id': 'EG000', 'title': 'Adequate Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.\n\nFor the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hamstring Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fold Change in microRNA Expression From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adequate Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion'}, {'id': 'OG001', 'title': 'Low Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.\n\nFor the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '.2', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exogenous Carbohydrate Oxidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adequate Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion'}, {'id': 'OG001', 'title': 'Low Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.\n\nFor the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion'}], 'classes': [{'categories': [{'measurements': [{'value': '.87', 'spread': '.16', 'groupId': 'OG000'}, {'value': '.84', 'spread': '.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '80 minutes', 'description': 'Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.', 'unitOfMeasure': 'g/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adequate Carbohydrate First, Then Low Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d first, then Low carbohydrate diet 1.5 g/kg/d\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion\n\n7 day washout\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion'}, {'id': 'FG001', 'title': 'Low Carbohydrate First, Then Adequate Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d first, then adequate carbohydrate diet 6.0 g/kg/d\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.\n\nFor the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion\n\n7 day washout\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a cross over design. 12 participants enrolled and completed both study arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adequate Carbohydrate First, Then Low Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d\n\nAdequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion'}, {'id': 'BG001', 'title': 'Low Carbohydrate First, Then Adequate Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d\n\nLow Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.\n\nFor the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This was a crossover study'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This was a crossover study'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This was a crossover study'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-23', 'size': 792988, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-03T08:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2017-07-19', 'resultsFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-06', 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fold Change in microRNA Expression From Baseline', 'timeFrame': '24 hours', 'description': 'Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.'}], 'secondaryOutcomes': [{'measure': 'Exogenous Carbohydrate Oxidation', 'timeFrame': '80 minutes', 'description': 'Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microRNA, carbohydrate oxidation'], 'conditions': ['Glycogen Depletion']}, 'descriptionModule': {'briefSummary': 'This investigation will examine the impact of skeletal muscle glycogen stores on skeletal muscle and circulating microRNA expression and exogenous carbohydrate oxidation.\n\nPrimary Objective Determine the influence of carbohydrate availability (e.g., glycogen depletion and repletion) on skeletal muscle microRNA expression, and if changes in circulating microRNA are reflective of changes in skeletal muscle microRNA.\n\nSecondary Objective Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency.', 'detailedDescription': 'Twelve, normal weight, healthy, physically active men and women will complete a glycogen depletion protocol, cycling at various intensities until failure. Participants will then consume a carbohydrate (CHO: 1 g/kg/hr) or an energy free control (CON) beverage matched for taste and color during the first 3-hr post glycogen depletion. For the remainder of the day participants will consume a diet designed to adequately (6.0 g CHO/kg/d) or inadequately (1.2 g CHO/kg/d) replenish glycogen stores. The following day participants will to complete 80-min of steady-state (\\~60% VO2peak) cycle ergometry consuming carbohydrate at a rate of 1.8 g/min enriched with a stable isotope of carbon to determine exogenous carbohydrate efficiency when glycogen stores are low or adequate at the onset of exercise.\n\nFollowing a minimum 7-d washout period volunteers will return to the laboratory to complete the second arm of the investigation. To ensure glycogen stores are similar between volunteers on testing day, 48-hrs prior to testing all volunteers will complete a glycogen depletion protocol and then consume a diet providing 6.0 g/kg/d carbohydrate to replenish glycogen stores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 - 39 years\n* Weight stable (±5 lbs) for at least 2 months prior to the start of the study\n* Body mass index (BMI) between 18.5-30 kg/m2\n* Recreationally active based on assessment of physical activity history 2-4 days per week aerobic and/or resistance exercise\n* Refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product for 10 days before and at least 5 days AFTER each muscle biopsy. (\\*Tylenol® or acetaminophen is ok to use if needed for discomfort)\n* Refrain from the use of alcohol and nicotine for the duration of the study\n* Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®, etc.)\n* Supervisor approved leave status for federal civilian employees working within the US Army Natick Soldier Systems Center\n\nExclusion Criteria:\n\n* Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)\n* Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise\n* Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study\n* Anemia (HCT \\< 38) and Sickle Cell Anemia/Trait\n* Abnormal prothrombin time (PT)/ partial thromboplastin time (PTT) test or problems with blood clotting\n* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues\n* Musculoskeletal injuries that compromise the ability to exercise\n* Blood donation within 8 weeks of beginning the study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03250234', 'briefTitle': 'Carbohydrate Availability and microRNA Expression', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression', 'orgStudyIdInfo': {'id': '17-17H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adequate Carbohydrate', 'description': 'Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d', 'interventionNames': ['Other: Adequate Carbohydrate']}, {'type': 'OTHER', 'label': 'Low Carbohydrate', 'description': 'Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d', 'interventionNames': ['Other: Low Carbohydrate']}], 'interventions': [{'name': 'Adequate Carbohydrate', 'type': 'OTHER', 'description': 'During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion', 'armGroupLabels': ['Adequate Carbohydrate']}, {'name': 'Low Carbohydrate', 'type': 'OTHER', 'description': 'During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.\n\nFor the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion', 'armGroupLabels': ['Low Carbohydrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01760', 'city': 'Natick', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'USARIEM', 'geoPoint': {'lat': 42.28343, 'lon': -71.3495}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}