Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05933460
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2023-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D008274', 'term': 'Magnesium'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'No participant or personnel knew the randomization process and the only knew did not had to do with participants or administration of supplement or collecting data. The company providing the supplement did not know either.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind placebo controlled randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycated hemoglobin', 'timeFrame': '6 months', 'description': 'glycated hemoglobin %'}, {'measure': 'blood glucose', 'timeFrame': '6 months', 'description': 'Fasting blood glucose (mg/dl)'}, {'measure': 'serum cholesterol', 'timeFrame': '6 months', 'description': 'Total Cholesterol mg/dl'}, {'measure': 'serum High density lipoprotein cholesterol', 'timeFrame': '6 months', 'description': 'High density lipoprotein Cholesterol mg/dl'}, {'measure': 'serum low density lipoprotein cholesterol', 'timeFrame': '6 months', 'description': 'Low density lipoprotein cholesterol mg/dl'}, {'measure': 'triglycerides', 'timeFrame': '6 months', 'description': 'serum Triglycerides mg/dl'}, {'measure': 'Systolic Blood pressure', 'timeFrame': '6 months', 'description': 'Systolic blood pressure mmHg'}, {'measure': 'Diastolic Blood pressure', 'timeFrame': '6 months', 'description': 'Diastolic blood pressure mmHg'}], 'secondaryOutcomes': [{'measure': 'Continuous glucose monitoring data', 'timeFrame': '6 months', 'description': 'Time in range %'}, {'measure': 'Continuous glucose monitoring time', 'timeFrame': '6 months', 'description': 'Time below range %'}, {'measure': 'Continuous glucose monitoring time data', 'timeFrame': '6 months', 'description': 'Time above range %'}, {'measure': 'Continuous glucose monitoring glycemic data', 'timeFrame': '6 months', 'description': 'Glucose Management Indicator %'}, {'measure': 'Continuous glucose monitoring statistic data', 'timeFrame': '6 months', 'description': 'Coefficient of variance'}, {'measure': 'Sural nerve conduction velocity', 'timeFrame': '6 months', 'description': 'Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck'}, {'measure': 'Electrochemical skin conductance', 'timeFrame': '6 months', 'description': 'Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)'}, {'measure': 'Cardiovascular Autonomic Reflex tests', 'timeFrame': '6 months', 'description': 'Autonomic neuropathy testing included cardiovascular autonomic reflex tests (CARTs) such as heart rate variability to obtain mean circular resultant (MCR), and the 30:15 stand up test to obtain postural index and blood pressure measurement to test for orthostatic hypotension'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus type 1', 'diabetes type 1', 'saffron', 'saffron extract', 'continuous glucose monitoring'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes type1']}, 'referencesModule': {'references': [{'pmid': '32423173', 'type': 'BACKGROUND', 'citation': 'Giannoulaki P, Kotzakioulafi E, Chourdakis M, Hatzitolios A, Didangelos T. Impact of Crocus Sativus L. on Metabolic Profile in Patients with Diabetes Mellitus or Metabolic Syndrome: A Systematic Review. Nutrients. 2020 May 14;12(5):1424. doi: 10.3390/nu12051424.'}]}, 'descriptionModule': {'briefSummary': 'Administration of 4 strain of probiotics, prebiotic, magnesium and crocus sativus extract in a sachet to people with diabetes mellitus type 1 for 6 months', 'detailedDescription': 'Double blind placebo controlled randomized trial: A sachet of a combination of 4 strains of probiotics (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides, Magnesium and Saffron extract was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with diabetes mellitus type 1 (with diabetes duration over 1 year) (adults \\<18 years old) wearing a continuous glucose monitoring system with or without an insulin pump\n\nExclusion Criteria:\n\n* Pregnant\n* People with diabetes mellitus type 2\n* Breastfeeding women\n* People with liver disease\n* People with chronic kidney disease (over stage 3)\n* People with allergy in crocus sativus\n* People that consume everyday herbs or supplements\n* People on anti platelet treatment not for prevention'}, 'identificationModule': {'nctId': 'NCT05933460', 'briefTitle': 'Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Diabetes1Crocus'}, 'secondaryIdInfos': [{'id': '1.46-21/11/2018', 'type': 'OTHER', 'domain': 'Aristotle University of Thessaloniki'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Group', 'description': 'A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Crocus sativus (Saffron extract 28mg) was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.', 'interventionNames': ['Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'A sachet of a combination of 4 strains of probiotics (1billion CFU(Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg without crocus sativus was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.', 'interventionNames': ['Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium']}], 'interventions': [{'name': 'dietary supplement with probiotics, prebiotics, magnesium and saffron extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotics and saffron extract'], 'description': 'A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Saffron extract 28mg was administered 3 times per day', 'armGroupLabels': ['Active Group']}, {'name': 'dietary supplement with probiotics, prebiotics, magnesium', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotics'], 'description': 'A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg was administered 3 times per day', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'state': 'Central Macedonia', 'country': 'Greece', 'facility': 'University General Hospital of Thessaloniki AHEPA', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Triantafyllos Didangelos, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine- Diabetology', 'investigatorFullName': 'Prof. Triantafyllos Didangelos', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}