Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT06671769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural Heart Health Supplement Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The "Natural Heart Health Supplement Trial" is designed as a single-arm treatment study, where participants will serve as their own controls. This innovative approach, termed a "Signal Phase" study at Efforia, aims to evaluate the potential efficacy and safety of an experimental natural heart health supplement over a 3-month period. Participants will consume a daily dose of the supplement, which is administered in a chocolate-flavored powdered format. The primary objective is to assess the impact of the supplement on key heart health biomarkers, including Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP). By utilizing this methodology, the study will provide preliminary insights into the supplement\'s effects, offering a directional indication of potential positive results.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': 'from Baseline to 30 day and 90 day.', 'description': 'Total Cholesterol as measured by an at-home blood collection kit returned to the lab'}, {'measure': 'HDL Cholesterol', 'timeFrame': 'from baseline to 30 day and 90 day', 'description': 'as measured by an at-home blood collection kit returned to the lab'}, {'measure': 'LDL Cholesterol', 'timeFrame': 'Baseline to 30 day and 90 day', 'description': 'as measured by an at-home blood collection kit returned to the lab'}, {'measure': 'Triglycerides', 'timeFrame': 'From baseline to 30 day and 90 day', 'description': 'as measured by at-home blood collection returned to lab'}], 'secondaryOutcomes': [{'measure': 'hs-CRP', 'timeFrame': 'from baseline to 30 day and 90 day', 'description': 'as measured by at-home blood test returned to a lab.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart health'], 'conditions': ['Cholesterol', 'Cholesterol (total and HDL)']}, 'descriptionModule': {'briefSummary': 'We are running a 3-month trial of an experimental natural heart health supplement. Participants will take a daily dose of an experimental natural heart health supplement in powdered format, chocolate flavor. The trial will assess changes in heart biomarkers such as Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP).', 'detailedDescription': "Heart disease is a leading cause of death in the United States, and maintaining healthy cholesterol levels is crucial for heart health. While social media and the press have focused on trendier treatments for general longevity, for most of us keeping our cholesterol in check will make a major impact. Research indicates that natural substances long used in Eastern medicine, can positively affect cholesterol levels and reduce inflammation, both vital for cardiovascular wellness.\n\nThis study aims to empower participants with evidence-based insights about the effectiveness of a natural heart health supplement in managing cholesterol levels and reducing inflammation. By participating, you'll contribute to valuable research while potentially enhancing your heart health through natural means.\n\nThis study aims to assess the impact of a natural heart health supplement on Total Cholesterol, HDL-C, LDL-C, Triglycerides, and hs-CRP levels over three months. Our objective is to provide evidence supporting or refuting the supplement's efficacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* Individuals with known soy allergies\n* Individuals with liver disease\n* Pregnant or breastfeeding individuals'}, 'identificationModule': {'nctId': 'NCT06671769', 'briefTitle': 'Natural Heart Health Supplement Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Efforia, Inc'}, 'officialTitle': 'Natural Heart Health Supplement Trial', 'orgStudyIdInfo': {'id': '34661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Natural Heart Health Dietary Supplement in Chocolate Powder Form', 'description': 'a natural heart-health dietary supplement in chocolate powder form designed to be taken daily.', 'interventionNames': ['Dietary Supplement: Heart Health Supplement']}], 'interventions': [{'name': 'Heart Health Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.', 'armGroupLabels': ['Natural Heart Health Dietary Supplement in Chocolate Powder Form']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Efforia - Study will be entirely online', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Matthew Amsden', 'role': 'CONTACT', 'email': 'help@efforia.com', 'phone': '(646) 679-2479'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Efforia, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}