Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 6:15 AM
Study NCT ID:
NCT04051034
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2019-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Therapy and Omega 3 on Cardio-Metabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Placebo or Omega 3 supplementation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic flexibility', 'timeFrame': 'Change from baseline to 12 week metabolic flexibility', 'description': 'Mixed meal tolerance test'}, {'measure': 'Microbiome', 'timeFrame': 'Change from baseline to 12 week in the phyla, genus and species of gut bacteria', 'description': 'Stool microbiome diversity'}, {'measure': 'Short chain fatty acids', 'timeFrame': 'Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).', 'description': 'Stool Short chain fatty acids'}, {'measure': 'Vascular Health', 'timeFrame': 'Change from baseline to 12 week vessel function', 'description': 'Brachial and skin flow mediated dilation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Currently, controlled studies are lacking which test the benefits of: 1) ω3 PUFA; and 2) heat therapy on improving vascular-metabolic-microbiota health in Hispanic American populations. The investigator's objective is to determine if this modality (heat therapy i.e., warm water immersion, hot tubs) combined with dietary interventions (increased fish and/or fish oil intake) may be feasible treatments to improve cardiovascular risk factors and reduced comorbidities in Hispanic populations.", 'detailedDescription': 'In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments:\n\n1. 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy\n2. Placebo pill daily for 12 weeks with 6 weeks of heat therapy (HT)\n\nnon-obese healthy will only serve as controls and enroll in placebo and neutral control therapy conditions.\n\nHT will entail 14 consecutive days of 1.5 hours passive heating (increase internal temperature 1.2°C above baseline), followed by 4 weeks of HT, 3 days per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>30-40,\n* fasting glucose 100-125,\n* blood pressure 130-139/80-89,\n* Hispanic American,\n* age 18-65 years\n\nExclusion Criteria:\n\n* non-Hispanic,\n* BMI\\<30, \\>40,\n* fasting glucose \\<100, \\>125,\n* blood pressure \\<130,\\>139 systolic, \\>90 diastolic,\n* age \\<18, \\>65 years'}, 'identificationModule': {'nctId': 'NCT04051034', 'briefTitle': 'Heat Therapy and Omega 3 on Cardio-Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health', 'orgStudyIdInfo': {'id': 'IRB2018-1199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega 3 supplementation', 'description': '12 weeks: Active: 1.25 g capsules/ \\[1.25 g capsule contains min. 750 mg EPA + 250 mg DHA\\] with heat therapy increasing internal body temperature 1.2C above baseline for 90 min each bout..', 'interventionNames': ['Dietary Supplement: Omega 3']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': '12 weeks: Placebo: 1.25 g capsules/ \\[1.25-gram high oleic safflower oil capsule\\]with heat therapy increasing internal body temperature 1.2C above baseline for 90 min each bout..', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Omega 3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Organic Technologies'], 'description': 'Active: 1.25 g capsules/420 35-count bottles \\[1.25 g capsule contains min. 750 mg EPA + 250 mg DHA\\] and heat therapy, increase internal body temperature 1.2 C above baseline.\n\nPlacebo: 14,700 1.25 g capsules/420 35-count bottles \\[1.25-gram high oleic safflower oil capsule\\]', 'armGroupLabels': ['Omega 3 supplementation']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Active: 1.25 g capsules \\[1.25-gram high oleic safflower oil capsule\\] and heat therapy, increase internal body temperature 1.2 C above baseline.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79424', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Rivas, Ph.D.', 'role': 'CONTACT', 'email': 'eric.rivas@ttu.edu', 'phone': '806-834-8563', 'phoneExt': '8068348563'}, {'name': 'Eric Rivas', 'role': 'CONTACT', 'email': 'eric.rivas@ttu.edu', 'phone': '8068348563', 'phoneExt': '8068348563'}], 'facility': 'Eric Rivas', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'centralContacts': [{'name': 'Eric Rivas, Ph.D.', 'role': 'CONTACT', 'email': 'eric.rivas@ttu.edu', 'phone': '806-834-8563'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eric Rivas', 'investigatorAffiliation': 'Texas Tech University'}}}}