Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05556967
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C459207', 'term': 'Immulina'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gamma-linolenic acid (GLA), ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'Sulfoquinovose (SQ), ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': "5'-methylsulfinyladenosine (MSA), ug/mL", 'timeFrame': 'Over 7 hour period', 'description': 'Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'palmitic acid, ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'linoleic acid, ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'palmitoleic acid, ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'steric acid, ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}, {'measure': 'oleic acid, ug/mL', 'timeFrame': 'Over 7 hour period', 'description': 'Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immulina TM', 'Healthy Participants', 'Natural Dietary Supplement'], 'conditions': ['Adherence, Patient']}, 'referencesModule': {'references': [{'pmid': '10500023', 'type': 'BACKGROUND', 'citation': 'Wu D, Meydani M, Leka LS, Nightingale Z, Handelman GJ, Blumberg JB, Meydani SN. Effect of dietary supplementation with black currant seed oil on the immune response of healthy elderly subjects. Am J Clin Nutr. 1999 Oct;70(4):536-43. doi: 10.1093/ajcn/70.4.536.'}, {'pmid': '15936647', 'type': 'BACKGROUND', 'citation': 'Tahvonen RL, Schwab US, Linderborg KM, Mykkanen HM, Kallio HP. Black currant seed oil and fish oil supplements differ in their effects on fatty acid profiles of plasma lipids, and concentrations of serum total and lipoprotein lipids, plasma glucose and insulin. J Nutr Biochem. 2005 Jun;16(6):353-9. doi: 10.1016/j.jnutbio.2005.01.004.'}, {'pmid': '17678567', 'type': 'BACKGROUND', 'citation': 'Geppert J, Demmelmair H, Hornstra G, Koletzko B. Co-supplementation of healthy women with fish oil and evening primrose oil increases plasma docosahexaenoic acid, gamma-linolenic acid and dihomo-gamma-linolenic acid levels without reducing arachidonic acid concentrations. Br J Nutr. 2008 Feb;99(2):360-9. doi: 10.1017/S0007114507801577. Epub 2007 Aug 3.'}, {'pmid': '9707349', 'type': 'BACKGROUND', 'citation': 'Martens-Lobenhoffer J, Meyer FP. Pharmacokinetic data of gamma-linolenic acid in healthy volunteers after the administration of evening primrose oil (Epogam). Int J Clin Pharmacol Ther. 1998 Jul;36(7):363-6.'}, {'type': 'BACKGROUND', 'citation': 'Xue, C.; Hu, Y.; Saito, H.; Zhang, Z.; Li, Z.; Cai, Y.; Ou, C.; Lin, H.; Imbs, A. B. Molecular species composition of glycolipids from Sprirulina platensis. Food Chemistry 2002, 77 (1), 9-13.'}, {'pmid': '28219973', 'type': 'BACKGROUND', 'citation': 'Goddard-Borger ED, Williams SJ. Sulfoquinovose in the biosphere: occurrence, metabolism and functions. Biochem J. 2017 Feb 20;474(5):827-849. doi: 10.1042/BCJ20160508.'}, {'type': 'BACKGROUND', 'citation': "Mills, J. S.; Mills, G. C.; Mcadoo, D. J. Isolation and identification of 5'-methylthioadenosine sulfoxide from human urine. Nucleosides and Nucleotides 1983, 2 (5), 465-478."}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before and after consumption of Immulina™, a natural dietary supplement).', 'detailedDescription': "This pilot study is interventional, and all participants will receive one 800 mg dose of Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR) to analyze and compare timed blood and urine samples using gas chromatography and liquid chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA), sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid, palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The mean of the 7 biomarkers for the 4 time points will be measured and compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18-50 years old\n* If female of childbearing potential, using acceptable means of birth control or postmenopausal for at least two years\n* Healthy\n\nExclusion Criteria:\n\n* pregnant or lactating females\n* significant acute disease\n* recurrent medications for chronic disease'}, 'identificationModule': {'nctId': 'NCT05556967', 'briefTitle': 'Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans', 'orgStudyIdInfo': {'id': '2022-363'}, 'secondaryIdInfos': [{'id': '1U19AT010838-01', 'link': 'https://reporter.nih.gov/quickSearch/1U19AT010838-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immulina Dietary Supplementation', 'description': 'Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.', 'interventionNames': ['Drug: Immulina']}], 'interventions': [{'name': 'Immulina', 'type': 'DRUG', 'otherNames': ['Spirulina'], 'description': 'Immulina is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.', 'armGroupLabels': ['Immulina Dietary Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Clinical Research and Trials Unit - University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Gailen D Marshall, Jr., MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}