Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT01378767
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2011-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Benefits of a 21-day Daniel Fast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2011-06-10', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Lipids', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'Total Cholesterol, LDL-C, HDL-C, VLDL-C, Triglyerides'}, {'measure': 'Glucoregulatory markers', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'Blood glucose, blood insulin, Serum resistin, serum adiponectin'}, {'measure': 'Markers of Oxidative Stress and Antioxidant Status', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'Plasma malondialdehyde, plasma hydrogen peroxide, plasma nitrate/nitrite, Trolox Equivalent Antioxidant Capacity (measured in serum)'}, {'measure': 'Blood Pressure', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'Systolic blood pressure, diastolic blood pressure'}, {'measure': 'C-reactive protein', 'timeFrame': 'Change from baseline at 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Anthropometric Variables', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'bodyweight, body mass index, waist circumference, hip circumference, body fat percentage, fat mass, fat free mass'}, {'measure': 'Metabolic Panel', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'Blood urea nitrogen, creatinine, sodium, potassium, carbon dioxide, calcium, protein, albumin, globulin, bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase'}, {'measure': 'Complete Blood Count', 'timeFrame': 'Change from baseline at 3 weeks', 'description': 'White blood cells, red blood cells, hemoglobin, hematocrit, mean cell volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, red blood cell distribution width, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dietary restriction', 'oxidative stress', 'fasting'], 'conditions': ['Effects of Krill Oil on Human Health']}, 'referencesModule': {'references': [{'pmid': '22971786', 'type': 'DERIVED', 'citation': 'Trepanowski JF, Kabir MM, Alleman RJ Jr, Bloomer RJ. A 21-day Daniel fast with or without krill oil supplementation improves anthropometric parameters and the cardiometabolic profile in men and women. Nutr Metab (Lond). 2012 Sep 13;9(1):82. doi: 10.1186/1743-7075-9-82.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that individuals supplementing with krill oil capsules (two grams per day) would experience enhanced improvements in health-related variables during a 21-day Daniel Fast.', 'detailedDescription': 'One of the main purposes of the this investigation was to determine if krill oil supplementation (two grams per day for 21 days) enhances the effects of a 21-day Daniel Fast, particularly in regards to blood lipids and lipid peroxidation. The investigators were also interested in determining if adiponectin and/or resistin change in response to the fast, as these adipokines could potentially mediate the favorable glucoregulatory changes the investigators observed in our initial investigation of a 21-day Daniel Fast. Finally, the investigators sought to determine the changes in macronutrient and micronutrient intake during a Daniel Fast, and how these dietary changes affect our selected hemodynamic, anthropometric, blood lipid, glucoregulatory, oxidative stress, inflammatory, renal, and hepatic biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years of age or older.\n* Must be willing to partake in a vegan diet for 21 days.\n* Must be willing to consume either krill oil or coconut oil capsules (assigned randomly).\n\nExclusion Criteria:\n\n* Smokers\n* regular consumption of antioxidant supplements\n* women who were pregnant or seeking to become pregnant\n* poor veins (veins that made it difficult to successfully obtain a blood draw - this was determined via a visual inspection)'}, 'identificationModule': {'nctId': 'NCT01378767', 'briefTitle': 'Health Benefits of a 21-day Daniel Fast', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'Biochemical, Hemodynamic, and Anthropometric Effects of a 21-day Daniel Fast in Men and Women', 'orgStudyIdInfo': {'id': '110184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Krill oil capsules', 'description': 'Two grams per day daily for 21 days', 'interventionNames': ['Dietary Supplement: Krill oil supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Coconut oil capsules', 'description': 'Two grams per day for 21 days', 'interventionNames': ['Dietary Supplement: Krill oil supplementation']}], 'interventions': [{'name': 'Krill oil supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Now Foods Neptune Krill Oil, 1000 mg- 60 Soft Gels', 'Brand NOW', 'Part Numbers 14431, 1627, 82048, NOW-01627, NWF-16270, NWF622', 'UPC 733739016270', 'Now Foods Coconut Oil, 1000 mg- 120 Soft Gels', 'Part Numbers 091363-2, 1718, 18918, 24230, 5933510, 6485, 71668, 806542, NWF-17185, NWF119', 'UPC 733739017185'], 'description': 'During a 21-day Daniel Fast, group one supplemented with krill oil capsules (two grams per day) while group two supplemented with a placebo (coconut oil capsules at two grams per day).', 'armGroupLabels': ['Coconut oil capsules', 'Krill oil capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38152', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Cardiorespiratory/Metabolic Laboratory', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Richard J Bloomer, Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Memphis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Richard Bloomer', 'oldOrganization': 'University of Memphis'}}}}