Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 5:41 PM
Study NCT ID:
NCT06549556
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum IL-1 Level', 'timeFrame': 'at Baseline, and After 60 days of treatment.', 'description': 'Measured in Pg/mL'}, {'measure': 'Serum IL-15 Level', 'timeFrame': 'at Baseline, and After 60 days of treatment.', 'description': 'Measured in Pg/mL'}, {'measure': 'Fasting Blood Sugar (FBS)', 'timeFrame': 'at Baseline, and After 60 days of treatment.', 'description': 'Measured in mg/dL'}, {'measure': 'Hemoglobin A1C (HbA1C)', 'timeFrame': 'at Baseline, and After 60 days of treatment.', 'description': 'Measured in percent from total Hemoglobin'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'at baseline, and after 60 days of treatment.', 'description': 'Measured in Kg/m²'}], 'secondaryOutcomes': [{'measure': 'Serum C-reactive protein (CRP)', 'timeFrame': 'At baseline, and after 60 days of treatment', 'description': 'Measured in mg/dL'}, {'measure': 'Rate Pressure Product', 'timeFrame': 'at Baseline, and after 60 days of treatment.', 'description': 'Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colostrum', 'Diabetes Mellitus, Type 2', 'Cognition', 'Physical Functional Performance'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:\n\n1. What are the effects of the tested regimens on the level of IL-1 and IL-15.\n2. What are the effects of the tested regimens on the Fasting Blood glucose?\n3. What are the effects of the tested regimens on the HbA1C?\n4. What are the effects of the tested regimens on the Body Mass Index?\n5. What are the effects of the tested regimens on the Lipid profile?\n6. What are the effects of the tested regimens on C-reactive protein?\n7. What are the effects of the tested regimens on Hematological indices?\n8. What are the effects of the tested regimens on Rate pressure product?\n\nParticipants will be separated into four groups:\n\n1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days\n2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.\n3. Group 3 (Diabetes Type 2): 23 Pateins, will be receiving Placebo Capsule per oral once daily for 60 days\n4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.\n\nResearchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on Fasting Blood Glucose, HbA1c, Lipid profile, Rate pressure product, C-reactive protein, Hematological indices, and Body Mass Index. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apperantly Healthy patients for control\n* Patients diagnosed with T2DM\n* Age between 18-70\n\nExclusion Criteria:\n\n* Patients with T1DM\n* Patients with a drug history of anabolic substances for more than 14 days duration.\n* Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)\n* Pregnancy, lactation, or female patient willing for conception.'}, 'identificationModule': {'nctId': 'NCT06549556', 'briefTitle': 'The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Al-Rasheed University College'}, 'officialTitle': 'The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes: A Case-management Comparative Study', 'orgStudyIdInfo': {'id': '4-3672 in 27/10/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1 (Healthy Control)', 'description': '24 Patients receiving Placebo Capsule per oral once daily for 60 days.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (Healthy control)', 'description': '26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.', 'interventionNames': ['Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 (Diabetes Type 2)', 'description': '23 Patients receiving Placebo Capsule per oral once daily for 60 days.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4 (Diabetes Type 2)', 'description': '27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.', 'interventionNames': ['Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)']}], 'interventions': [{'name': 'Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)', 'type': 'DRUG', 'description': 'Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.', 'armGroupLabels': ['Group 2 (Healthy control)', 'Group 4 (Diabetes Type 2)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo Capsule / Capsules per oral / once daily / 60 days duration', 'armGroupLabels': ['Group 1 (Healthy Control)', 'Group 3 (Diabetes Type 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52001', 'city': 'Wāsiţ', 'country': 'Iraq', 'facility': 'Al-Zahraa Teaching Hospital', 'geoPoint': {'lat': 32.38333, 'lon': 45.225}}], 'overallOfficials': [{'name': 'Ahmed Khalid Mohammed Albasri, MSc. Pharmacology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Farabi Kazakh National University'}, {'name': 'Hayder Adnan Fawzi, PhD. Clinical Pharmacy', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Rasheed University College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Rasheed University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Farabi Kazakh National University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof', 'investigatorFullName': 'Hayder Adnan Fawzi', 'investigatorAffiliation': 'Al-Rasheed University College'}}}}