Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 9:51 AM
Study NCT ID:
NCT01784692
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2013-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C459207', 'term': 'Immulina'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interferon gamma (IFNg)', 'timeFrame': '8 weeks', 'description': 'Increase in IFNg from baseline to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Psychological Measures', 'timeFrame': '8 weeks', 'description': 'Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry'}, {'measure': 'Optimal supplement regime', 'timeFrame': '8 weeks', 'description': 'Optimizing Immulina dose for maximal immune biomarker levels observing changes in Treg, Tr1, Th3, T Helper1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks'}, {'measure': 'Demographic differences', 'timeFrame': '8 weeks', 'description': 'Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status'}, {'measure': 'Immune biomarkers', 'timeFrame': '8 weeks', 'description': 'Changes in Treg, Tr1, Th3, T Helper 1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks'}]}, 'conditionsModule': {'keywords': ['Immulina', 'Elderly', 'Immune'], 'conditions': ['Elderly Immune Senescence']}, 'descriptionModule': {'briefSummary': 'This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 and older;\n* Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).\n\nExclusion Criteria:\n\n* Inability to comprehend and speak English;\n* Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;\n* Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.'}, 'identificationModule': {'nctId': 'NCT01784692', 'briefTitle': 'Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals', 'orgStudyIdInfo': {'id': '2012-0255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10 participants will be randomized to take 1 capsule of placebo daily.', 'interventionNames': ['Dietary Supplement: Immulina']}, {'type': 'EXPERIMENTAL', 'label': 'Immulina 200 mg/day', 'description': '10 participants will be randomized to take 200 mg/day of Immulina.', 'interventionNames': ['Dietary Supplement: Immulina']}, {'type': 'EXPERIMENTAL', 'label': 'Immulina 400 mg/day', 'description': '10 participants will be randomized to take 400 mg/day of Immulina.', 'interventionNames': ['Dietary Supplement: Immulina']}, {'type': 'EXPERIMENTAL', 'label': 'Immulina 800 mg/day', 'description': '10 participants will be randomized to take 800 mg/day of Immulina.', 'interventionNames': ['Dietary Supplement: Immulina']}], 'interventions': [{'name': 'Immulina', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Spirulina'], 'armGroupLabels': ['Immulina 200 mg/day', 'Immulina 400 mg/day', 'Immulina 800 mg/day', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research', 'investigatorFullName': 'Gailen D. Marshall', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}