Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05130905
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2021-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RiteStart Personal Nutritional Dietary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary IgA', 'timeFrame': '12 weeks', 'description': 'Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.'}, {'measure': 'Serum folate level', 'timeFrame': '12 weeks', 'description': 'Serum folate level was measured in blood sample collected from participants'}, {'measure': 'Serum vitamin B12 level', 'timeFrame': '12 weeks', 'description': 'Serum vitamin B12 level was measured in blood sample collected from participants'}, {'measure': 'Serum vitamin D level', 'timeFrame': '12 weeks', 'description': 'Serum vitamin D level was measured in blood sample collected from participants'}], 'secondaryOutcomes': [{'measure': 'Alanine Aminotransferase (ALT) Activity', 'timeFrame': '12 weeks', 'description': 'ALT activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment'}, {'measure': 'Aspartate Aminotransferase (AST) activity', 'timeFrame': '12 weeks', 'description': 'AST activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment'}, {'measure': 'Gamma-Glutamyl Transpeptidase (GGT) activity', 'timeFrame': '12 weeks', 'description': 'GGT activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunity', 'Salivary IgA', 'Bovine Colostrum', 'Brain Health', 'Heart Health'], 'conditions': ['Healthy Nutrition']}, 'descriptionModule': {'briefSummary': 'This study is undertaken to explore the effects of a bovine colostrum containing MVM (RiteStart) on different health aspects by quantitatively assessing relevant serum and saliva biomarkers, over a 12-week period in participants.', 'detailedDescription': 'Blood samples were drawn by a certified phlebotomist, prepared, and then analyzed by a Clinical Laboratory Improvement Amendments (CLIA)-certified independent laboratory. The following components were measured in sera from the participants: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transpeptidase (GGT), Red Blood Cell Count (RBC), Hematocrit (HCT), Mean Cell Volume (MCV), Mean Cell Hemoglobin (MCH), Mean Cell Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), Platelets, Mean Platelet Volume (MPV), Monocytes, Neutrophils, Lymphocytes, Eosinophils, Basophils, Hemoglobin, Ferritin, Total Iron Binding Capacity (TIBC), Iron, Transferrin Saturation (TS), Folate, Vitamin B12, Calcium, Vitamin D, Magnesium, Red Blood Cell Magnesium, Potassium, Sodium, Creatine Kinase (CK), Testosterone, Free Testosterone, Dehydroepiandrosterone-sulfate (DHEAS), Cortisol, Sex Hormone Binding Globulin (SHBG), Albumin, Glucose, Total Cholesterol, High-Density Lipoprotein cholesterol (HDL), Low-Density Lipoprotein cholesterol (LDL), Triglycerides, White Blood Cell Count (WBC), High Sensitivity C-Reactive Protein (hsCRP). Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Employees and family and friends of employees.\n2. Adults committed to attend all of the sessions and follow the instructions described in Experimental Design.\n3. Participants of both genders and of ages \\>18 will be included.\n4. Participants with the best chance to benefit from taking the product, i.e., participants that are not in the optimal health/level as per answers in the health questionnaire, but that are not diseased.\n\nExclusion Criteria\n\n1. Pregnant and nursing women.\n2. Those currently taking 4Life TF Plus and/or other supplements containing vitamins, minerals, and essential fatty acids (EPA/DHA, fish oil, omega 3), and those that have taken any of these supplements up to 1 month prior to first study visit.\n3. Those participants that reported to take daily medications to treat a chronic condition. However, birth control pill does not count.\n4. Those participants with allergies to any of the ingredients of the product including high sensitivity to lactose.\n5. Participants that smoke and with body mass index (BMI) either \\< 19 or \\> 30 will also be excluded.'}, 'identificationModule': {'nctId': 'NCT05130905', 'acronym': 'RESPOND', 'briefTitle': 'RiteStart Personal Nutritional Dietary Study', 'organization': {'class': 'INDUSTRY', 'fullName': '4Life Research, LLC'}, 'officialTitle': 'Safety and Efficacy of a Multivitamin, Multimineral, Bovine Colostrum Containing Supplement RiteStart: An Open Label Trial', 'orgStudyIdInfo': {'id': 'RSC-012-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplementation with RiteStart', 'description': 'Once enrolled into the study, participants were instructed to take RiteStart Supplement daily for 12 weeks.', 'interventionNames': ['Dietary Supplement: RiteStart Supplement']}], 'interventions': [{'name': 'RiteStart Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'RiteStart is a comprehensive multivitamin, multimineral, all-in-one daily supplement. Besides having comprehensive and balanced amounts of essential vitamins and minerals that the human body needs, RS includes many other health-promoting ingredients. For example, RS contains potent antioxidants, including vitamins A, C, and E, oligomeric proanthocyanidins from pinebark and grapeseed extracts, lutein, CoQ10, alpha-lipoic acid, and green tea. It is also a source of essential fatty acids from fish and plant oils. RS contains transfer factor (bovine colostrum and egg yolk extracts) that support immunity \\[6, 7, 8\\]. RS also includes a blend of maitake mushrooms, shiitake mushrooms, cordyceps, inositol hexaphosphate, olive leaf extract, and other ingredients that aim to further support immune function and overall health.', 'armGroupLabels': ['Supplementation with RiteStart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84070', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': '4Life Research', 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}], 'overallOfficials': [{'name': 'David Vollmer, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '4Life Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4Life Research, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}