Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07142720
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2025-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008247', 'term': 'laminaran'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Participants will not be informed on which intervention they receive on any given day.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Placebo-controlled, double-blinded, cross-over study design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stem Cell Numbers in Blood', 'timeFrame': '2 hours', 'description': 'Changes to stem cell surveillance, i.e. the changes in stem cell populations following consumption of the study product: Numbers of CD45dimCD34+CD309+ pluripotential stem cells Numbers of Cd45dim CD34+CD309- progenitor stem cells Numbers of CD45-CD90+ lymphocytes in blood Numbers of CD31++ CD34- endothelial stem cells in blood'}], 'primaryOutcomes': [{'measure': 'Antioxidant uptake and protection', 'timeFrame': '2 hours', 'description': 'Changes to antioxidant status of blood samples'}], 'secondaryOutcomes': [{'measure': 'Immune cell numbers in blood', 'timeFrame': '2 hours', 'description': 'Changes to immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following consumption: Numbers of CD3- CD56+ NK cells in blood Numbers of CD3+ CD56+ NKT cells in blood Numbers of CD3+ CD56- T cells in blood Numbers of cells positive for CD25 Numbers of cells positive for CD69'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Surveillance', 'Stem Cell Surveillance']}, 'descriptionModule': {'briefSummary': 'This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo.\n\nA double-blind, placebo-controlled, cross-over study design will be used.', 'detailedDescription': 'For each participant, the clinic visits are scheduled at the same time of the day during the morning hours of 7-11 am to control for the effect of circadian fluctuations. One clinic visit involves consuming a placebo and serves as a control for the circadian variations in cytokine levels and immune surveillance for each participant. Since there is interference from exercise and stress with the release versus homing of lymphocytes, the study environment is managed so that any physical and mental stress is minimized during each visit. Upon arrival at a clinic visit, participants complete a questionnaire to help monitor exceptional circumstances that may influence the stress level of that person on that day. Predetermined criteria for re-scheduling a visit include sleep deprivation and acute anxiety. After completing the questionnaire, participants are instructed to remain calm and inactive for 2 hours, comfortably seated in a chair. After the first hour, the baseline blood sample is drawn. Immediately after the baseline sample is drawn, a test product is provided and consumed in the presence of clinic staff. Blood samples are drawn at 1 hour and 2 hours after consumption of the test product or placebo.\n\nThe blood is tested for antioxidant status, immune cell surveillance, and regenerating properties involving stem cell surveillance. The process of surveillance is the natural process of our immune and stem cells to move through our body and detect problems that need repair. In addition, blood samples are tested for changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factors.'}, '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* Veins easy to see in one or both arms (to allow for the multiple blood draws);\n* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;\n* Willing to comply with study procedures, including:\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, 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* Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;\n* Known food allergies related to ingredients in active test product or placebo.'}, 'identificationModule': {'nctId': 'NCT07142720', 'briefTitle': 'Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity', 'organization': {'class': 'OTHER', 'fullName': 'Natural Immune Systems Inc'}, 'officialTitle': 'Clinical Study on Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity', 'orgStudyIdInfo': {'id': '176-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo visit before Active product visit', 'description': 'Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention.', 'interventionNames': ['Dietary Supplement: A seaweed extract from brown seaweed, containing fucoidan, laminarin, and the antioxidant phlorotannin.']}, {'type': 'EXPERIMENTAL', 'label': 'Active product visit before placebo visit', 'description': 'Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo.', 'interventionNames': ['Dietary Supplement: A seaweed extract from brown seaweed, containing fucoidan, laminarin, and the antioxidant phlorotannin.']}], 'interventions': [{'name': 'A seaweed extract from brown seaweed, containing fucoidan, laminarin, and the antioxidant phlorotannin.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Portions of the seaweed extract were dissolved in rice milk to help camouflage the strong algae-taste. Plain rice milk served as placebo.', 'armGroupLabels': ['Active product visit before placebo visit', 'Placebo visit before Active product visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97601', 'city': 'Klamath Falls', 'state': 'Oregon', 'country': 'United States', 'facility': 'NIS Labs', 'geoPoint': {'lat': 42.22487, 'lon': -121.78167}}], 'overallOfficials': [{'name': 'Gitte S. Jensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIS Labs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Immune Systems Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investogator', 'investigatorFullName': 'Gitte Jensen, Ph.D.', 'investigatorAffiliation': 'Natural Immune Systems Inc'}}}}