Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-03 @ 2:34 PM
Study NCT ID:
NCT05191758
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2021-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Regulation of Leukocyte Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation', 'timeFrame': '6 weeks post supplementation', 'description': 'The major objectives of the study is to study the mechanism of action on ROS production by leucocytes of healthy subjects post 6 weeks FPP supplementation measured by flowcytometry'}, {'measure': 'Blood leukocyte phagocytosis 6 weeks post supplementation', 'timeFrame': '6 weeks post supplementation', 'description': 'Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique'}], 'secondaryOutcomes': [{'measure': 'Leukocyte activation and cytokine production at 6 wks post supplementation', 'timeFrame': '5 weeks', 'description': 'Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fermented papaya', 'wound healing responses'], 'conditions': ['FPP', 'Fermented Papaya Preparation', 'Supplements', 'Diabetic Wound', 'Healing Wound']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.', 'detailedDescription': 'Fermented Papaya Preparation (FPP) is a dietary supplement that is available as over-the-counter in the US. FPP possesses antioxidant properties, which provide benefit against age-related complications\\[\\]. Chronic wounds in patients with diabetes represent a major public health problem. Previous studies from the investigators have demonstrated that wound-site macrophages from patients with diabetes are compromised in their ability to support wound healing. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. Our laboratory reported the first evidence demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. FPP has a long track record of safe human consumption. The objective of the current study is to determine the dose at which FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 and above\n* Subjects must be able to follow directions and give informed consent on their own\n\nExclusion Criteria:\n\n* • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded.\n\n * Females who are pregnant will also be excluded to minimize the risk to such individuals (and fetus).\n * Individuals who are therapeutically immuno-compromised will also be excluded to decrease statistical variability and to minimize potential of confounders.\n * Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable.'}, 'identificationModule': {'nctId': 'NCT05191758', 'acronym': 'FPP Supplement', 'briefTitle': 'Nutritional Regulation of Leukocyte Function', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Nutritional Regulation of Leukocyte Function', 'orgStudyIdInfo': {'id': '13229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no supplements will be taken'}, {'type': 'EXPERIMENTAL', 'label': '3 grams of supplements', 'description': 'subjects will take 3 grams of supplements once per day', 'interventionNames': ['Dietary Supplement: FPP supplement']}, {'type': 'EXPERIMENTAL', 'label': '6 grams of supplements', 'description': 'subjects will take 3 grams of supplements twice per day', 'interventionNames': ['Dietary Supplement: FPP supplement']}, {'type': 'EXPERIMENTAL', 'label': '9 grams of supplements', 'description': 'subjects will take 3 grams of supplements three times per day', 'interventionNames': ['Dietary Supplement: FPP supplement']}], 'interventions': [{'name': 'FPP supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fermented Papaya Preparation Supplement (FPP)', 'FPP'], 'description': 'Participants will take the supplements per randomization', 'armGroupLabels': ['3 grams of supplements', '6 grams of supplements', '9 grams of supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46228', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Sashwati Roy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osato Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Dr. Sashwati Roy', 'investigatorAffiliation': 'Indiana University'}}}}