Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT03725969
Status:
UNKNOWN
Last Update Posted:
2020-02-12
First Post:
2018-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Camel Milk on Insulin and Incretin Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-10-14', 'studyFirstSubmitQcDate': '2018-10-28', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose response to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of peak of glucose'}, {'measure': 'Response of glucose to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of area under the curve'}], 'secondaryOutcomes': [{'measure': 'Insulin response to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of peak'}, {'measure': 'Response of insulin to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of area under the curve'}, {'measure': 'GLP-1 response to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of peak'}, {'measure': 'Response of GLP-1 to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of area under the curve'}, {'measure': 'C-peptide response to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of peak'}, {'measure': 'Response of C-peptide to camel and cow milk', 'timeFrame': '5 months', 'description': 'The difference between interventions in terms of area under the curve'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Sensitivity', 'Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance', 'detailedDescription': 'Camel milk is used as a traditional remedy throughout the Middle East and Indian Subcontinent for conditions such as type 2 diabetes and dyslipidemia. It is currently unclear how such an effect could be mediated in vivo and studies are limited. We performed this study as a pilot experiment to assess the effects of camel milk on Insulin, Glucose, GLP-1, C-peptide and Lipid profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal glucose tolerance\n* BMI \\< 30 kg/m2\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Type 2 diabetes mellitus\n* Impaired fasting glucose or impaired glucose tolerance\n* Lactose intolerance\n* Weight loss / gain ≥ 5 kg in the preceding two months\n* Use of estrogenic drugs or corticosteroids\n* Known hypertriglyceridemia requiring treatment\n* History of heart attack, angina or cardiovascular disorder\n* History of malignant tumor\n* Pregnant or lactating women\n* Hemoglobin \\< 12 for any reason\n* Recent surgery or major hemorrhage\n* History of bariatric or metabolic surgery'}, 'identificationModule': {'nctId': 'NCT03725969', 'briefTitle': 'Effect of Camel Milk on Insulin and Incretin Response', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London Diabetes Centre'}, 'officialTitle': 'The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance', 'orgStudyIdInfo': {'id': 'IREC033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy individuals (camel milk)', 'interventionNames': ['Dietary Supplement: Camel milk']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy individuals (cow milk)', 'interventionNames': ['Dietary Supplement: Cow milk']}], 'interventions': [{'name': 'Camel milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions', 'armGroupLabels': ['Healthy individuals (camel milk)']}, {'name': 'Cow milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions', 'armGroupLabels': ['Healthy individuals (cow milk)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48338', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Nader Lessan, MBBS MD FRCP', 'role': 'CONTACT', 'email': 'nlessan@icldc.ae', 'phone': '+971 2 404 0800'}, {'name': 'Hinda Daggag, PhD', 'role': 'CONTACT', 'email': 'hdaggag@icldc.ae', 'phone': '+971 2 404 0800'}], 'facility': 'Imperial College London Diabetes Centre', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Dr Nader Lessan, MBBS MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London Diabetes Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London Diabetes Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}