Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04677920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2020-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in mitochondria function', 'timeFrame': 'Week 0 to Week 2', 'description': 'Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle'}, {'measure': 'Changes in cardiolipin species', 'timeFrame': 'Week 0 to week 2', 'description': 'Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle'}, {'measure': 'Correlation of mitochondrial biology in blood and skeletal muscle', 'timeFrame': 'Week 0 and week 2', 'description': 'Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle'}], 'secondaryOutcomes': [{'measure': 'Changes in fasting fatty acid levels', 'timeFrame': 'Week 0 to week 2', 'description': 'Linoleic acid content of fasting blood samples'}, {'measure': 'Correlation of fatty acids with mitochondrial function and cardiolipin species', 'timeFrame': 'Week 0 and week 2', 'description': 'Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle'}, {'measure': 'Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats', 'timeFrame': 'Week 0 and week 2', 'description': 'Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of sleep quality using the Pittsburgh Sleep Quality Index, physical activity using the Epic Physical activity short questionnaire and dietary omega-3 intake using the Omega-3 Checklist'}, {'measure': 'Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength', 'timeFrame': 'Week 0 and week 2', 'description': 'Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.', 'detailedDescription': 'Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria.\n\nThe investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims\n\nAim 1) To assess muscle biopsy yield with a micro biopsy needle\n\nAim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function\n\nAim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples\n\nAim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonsmoker\n\nExclusion Criteria:\n\n* Allergy/intolerance to lidocaine\n* Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery\n* Food Allergy or Intolerance\n* Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated\n* Use of medications where consuming the healthy cookies would be contraindicated\n* Pregnancy\n* Use of anticoagulant, antiplatelet, or other blood thinner medications\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT04677920', 'acronym': 'HCES', 'briefTitle': 'The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology', 'orgStudyIdInfo': {'id': '2020H0352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Cookie Group', 'description': 'All participants in the study', 'interventionNames': ['Other: High Linoleic Acid Healthy Cookies']}], 'interventions': [{'name': 'High Linoleic Acid Healthy Cookies', 'type': 'OTHER', 'description': 'High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks', 'armGroupLabels': ['Healthy Cookie Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Martha Belury', 'investigatorAffiliation': 'Ohio State University'}}}}