Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-02 @ 10:14 AM
Study NCT ID:
NCT07127705
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Response of Stem Cells and Immune Cells for Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}, {'id': 'C000627506', 'term': 'olive extract'}, {'id': 'C402622', 'term': 'potassium hydrogen glucarate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Placebo-controlled, randomized, double-blinded, cross-over study design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stem cell trafficking', 'timeFrame': 'Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug', 'description': 'Changes to the number of stem cells in the blood circulation (number of cells per mL blood).\n\nData is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.'}], 'secondaryOutcomes': [{'measure': 'Mitochondrial volume per cell', 'timeFrame': 'Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug', 'description': 'Mitochondrial volume per cell under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.'}, {'measure': 'Mitochondrial membrane potential per cell', 'timeFrame': 'Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug', 'description': 'Cellular energy production under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cells, using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stem Cell Surveillance']}, 'descriptionModule': {'briefSummary': 'The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.', 'detailedDescription': 'This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.\n\nData on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults;\n* Age 18 - 75 years (inclusive);\n* BMI between 18.0 and 34.9 (inclusive);\n* Veins easy to see in one or both arms (to allow for the multiple blood draws);\n* Willing to comply with study procedures, including:\n\n * Maintaining a consistent diet and lifestyle routine throughout the study,\n * Consistent habit of bland breakfasts on days of clinic visits,\n * Abstaining from exercising and nutritional supplements on the morning of a study visit,\n * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;\n * Abstaining from music, candy, gum, computer/cell phone use (airplane mode is allowed), during clinic visits.\n\nExclusion Criteria:\n\n* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);\n* Taking anti-inflammatory medications on a daily basis;\n* Currently experiencing intense stressful events/ life changes;\n* Currently in intensive athletic training (such as marathon runners);\n* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;\n* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);\n* Unwilling to maintain a constant intake of supplements over the duration of the study;\n* Anxiety about having blood drawn;\n* Pregnant, nursing, or trying to become pregnant;\n* Known food allergies related to ingredients in active test product or placebo.'}, 'identificationModule': {'nctId': 'NCT07127705', 'briefTitle': 'Rapid Response of Stem Cells and Immune Cells for Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Natural Immune Systems Inc'}, 'officialTitle': 'Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial', 'orgStudyIdInfo': {'id': '186-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crossover group 1, randomized', 'description': 'Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E.', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Chaga Mushroom', 'Dietary Supplement: Ginseng extract', 'Dietary Supplement: Olive extract', 'Dietary Supplement: Potassium Hydrogen Glucarate']}, {'type': 'EXPERIMENTAL', 'label': 'Crossover group 2, randomized', 'description': 'Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D.', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Chaga Mushroom', 'Dietary Supplement: Ginseng extract', 'Dietary Supplement: Olive extract', 'Dietary Supplement: Potassium Hydrogen Glucarate']}, {'type': 'EXPERIMENTAL', 'label': 'Crossover group 3, randomized', 'description': 'Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B.', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Chaga Mushroom', 'Dietary Supplement: Ginseng extract', 'Dietary Supplement: Olive extract', 'Dietary Supplement: Potassium Hydrogen Glucarate']}, {'type': 'EXPERIMENTAL', 'label': 'Crossover group 4, randomized', 'description': 'Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E.', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Chaga Mushroom', 'Dietary Supplement: Ginseng extract', 'Dietary Supplement: Olive extract', 'Dietary Supplement: Potassium Hydrogen Glucarate']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Crossover group 1, randomized', 'Crossover group 2, randomized', 'Crossover group 3, randomized', 'Crossover group 4, randomized']}, {'name': 'Chaga Mushroom', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Crossover group 1, randomized', 'Crossover group 2, randomized', 'Crossover group 3, randomized', 'Crossover group 4, randomized']}, {'name': 'Ginseng extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Crossover group 1, randomized', 'Crossover group 2, randomized', 'Crossover group 3, randomized', 'Crossover group 4, randomized']}, {'name': 'Olive extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Crossover group 1, randomized', 'Crossover group 2, randomized', 'Crossover group 3, randomized', 'Crossover group 4, randomized']}, {'name': 'Potassium Hydrogen Glucarate', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Crossover group 1, randomized', 'Crossover group 2, randomized', 'Crossover group 3, randomized', 'Crossover group 4, randomized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97601', 'city': 'Klamath Falls', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gitte S. Jensen, PhD', 'role': 'CONTACT', 'email': 'Gitte@nislabs.com', 'phone': '541-884-0112'}], 'facility': 'NIS Labs', 'geoPoint': {'lat': 42.22487, 'lon': -121.78167}}], 'centralContacts': [{'name': 'Gitte S. Jensen, PhD', 'role': 'CONTACT', 'email': 'Gitte@nislabs.com', 'phone': '5418820112'}, {'name': 'Alex Cruickshank', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Immune Systems Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Applied Food Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}