Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-22 @ 1:50 PM
Study NCT ID:
NCT04029558
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2019-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IgM', 'timeFrame': '4 weeks', 'description': 'Immunoglobulin M plasma levels'}, {'measure': 'IgA', 'timeFrame': '4 weeks', 'description': 'Immunoglobulin A plasma levels'}, {'measure': 'IgG', 'timeFrame': '4 weeks', 'description': 'Immunoglobulin G plasma levels'}], 'secondaryOutcomes': [{'measure': 'IL-2', 'timeFrame': '4 weeks', 'description': 'Plasma levels of interleukin-2'}, {'measure': 'IL-8', 'timeFrame': '4 weeks', 'description': 'Plasma levels of interleukin-8'}, {'measure': 'TNF-alpha', 'timeFrame': '4 weeks', 'description': 'Plasma levels of tumor necrosis factor alpha'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune response', 'Plant extracts', 'Dietary supplement'], 'conditions': ['Immune Response']}, 'descriptionModule': {'briefSummary': 'The aim of the present trial is to study the effect of the combination of plant extracts (BSL\\_EP024) in the activation of the immune response.', 'detailedDescription': 'More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.\n\nThe aim of the present study is to evaluate the effect of the combination of plant extracts (BSL\\_EP024) on immunological response parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult between 18 and 55 years.\n* Accept freely to participate in the study and sign the informed consent document.\n\nExclusion Criteria:\n\n* Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).\n* Have allergy to some plant extracts\n* Suffer from gastric problems or ulcers.\n* Receive treatment with anticoagulant activity.\n* Have a low expectation of adherence to the study protocol.'}, 'identificationModule': {'nctId': 'NCT04029558', 'briefTitle': 'Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosearch S.A.'}, 'officialTitle': 'Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults', 'orgStudyIdInfo': {'id': 'C024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination of plant extracts (BSL_EP024)', 'description': 'The volunteers will take two capsules daily with a combination of plant extracts (BSL\\_EP024)', 'interventionNames': ['Dietary Supplement: Combination of Plant Extracts (BSL_EP025)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The volunteers will take two capsules daily with maltodextrin.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Combination of Plant Extracts (BSL_EP025)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant will consume 2 capsules daily at lunch for 8 weeks.', 'armGroupLabels': ['Combination of plant extracts (BSL_EP024)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant will consume 2 capsules daily at lunch for 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18004', 'city': 'Granada', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Biosearch Life', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Miguel Quesada, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical specialist in Endocrinology, Hospital San Cecilio de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosearch S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}