Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT01180712
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2010-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Oral Anthocyanins on Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-12', 'size': 169024, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-01T09:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Glucose Tolerance Test', 'timeFrame': 'Day 0 and 21 days post intervention', 'description': 'Change in Oral Glucose Tolerance following intervention'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose/insulin', 'timeFrame': 'Day 0, 7, 14, and 21 days post intervention', 'description': 'Change in fasting blood glucose/insulin in response to intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anthocyanin', 'blaeberries', 'bilberries', 'blueberries', 'mirtoselect', 'type 2 diabetes', 'insulin resistance', 'Adipose tissue', 'inflammation'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '16979328', 'type': 'BACKGROUND', 'citation': 'Martineau LC, Couture A, Spoor D, Benhaddou-Andaloussi A, Harris C, Meddah B, Leduc C, Burt A, Vuong T, Mai Le P, Prentki M, Bennett SA, Arnason JT, Haddad PS. Anti-diabetic properties of the Canadian lowbush blueberry Vaccinium angustifolium Ait. Phytomedicine. 2006 Nov;13(9-10):612-23. doi: 10.1016/j.phymed.2006.08.005. Epub 2006 Sep 18.'}, {'pmid': '17533652', 'type': 'BACKGROUND', 'citation': 'Zafra-Stone S, Yasmin T, Bagchi M, Chatterjee A, Vinson JA, Bagchi D. Berry anthocyanins as novel antioxidants in human health and disease prevention. Mol Nutr Food Res. 2007 Jun;51(6):675-83. doi: 10.1002/mnfr.200700002.'}, {'pmid': '17265471', 'type': 'BACKGROUND', 'citation': 'Lau FC, Bielinski DF, Joseph JA. Inhibitory effects of blueberry extract on the production of inflammatory mediators in lipopolysaccharide-activated BV2 microglia. J Neurosci Res. 2007 Apr;85(5):1010-7. doi: 10.1002/jnr.21205.'}, {'pmid': '19515743', 'type': 'BACKGROUND', 'citation': 'DeFuria J, Bennett G, Strissel KJ, Perfield JW 2nd, Milbury PE, Greenberg AS, Obin MS. Dietary blueberry attenuates whole-body insulin resistance in high fat-fed mice by reducing adipocyte death and its inflammatory sequelae. J Nutr. 2009 Aug;139(8):1510-6. doi: 10.3945/jn.109.105155. Epub 2009 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'Dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions The genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. The association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance.\n\nThe aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese male subjects (BMI \\> 30)\n* Aged \\> 40 and \\< 70 years of age\n* Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance\n* All the obese subjects will have a waist circumference over 40 inches\n* All subjects must live the Aberdeenshire area of Scotland\n\nExclusion Criteria:\n\nMedical exclusion criteria:\n\n* Chronic illness, including:\n\n * thromboembolic or coagulation disease,\n * unregulated thyroid disease,\n * kidney disease,\n * hepatic disease,\n * severe gastrointestinal disorders,\n * pulmonary disease (e.g. chronic bronchitis, COPD),\n* Alcohol or any other substance abuse,\n* Eating disorders,\n* Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),\n* Skin conditions on the abdomen,\n* Allergy to skin dressings,\n\nMedication exclusion criteria:\n\n* Oral steroids,\n* Tricyclic antidepressants, neuroleptics,\n* Anticoagulants,\n* Digoxin and antiarrhythmics,\n* Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),\n* Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin'}, 'identificationModule': {'nctId': 'NCT01180712', 'briefTitle': 'Study of Oral Anthocyanins on Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Study of Oral Anthocyanins on Insulin Resistance', 'orgStudyIdInfo': {'id': 'REC 10/S0802/27'}, 'secondaryIdInfos': [{'id': 'Rowett 901', 'type': 'OTHER', 'domain': 'Rowett institute study code'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blaeberry concentrated caspule', 'description': '30 obese male subjects (BMI \\> 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.\n\nVolunteers will be given a total daily dose of 1.4 grams of mirtoselect (a concentrated blaeberry extract) a day formulated in hard gelatin capsules (0.47 gram per capsule) administered thrice a day for 21 days.\n\nMirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/)', 'interventionNames': ['Dietary Supplement: Mirtoselect']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules containing lactose', 'description': '30 obese male subjects (BMI \\> 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.\n\nVolunteers will be given a placebo consisting of lactose formulated in hard gelatin capsules administered thrice a day for 21 days.', 'interventionNames': ['Dietary Supplement: Mirtoselect']}], 'interventions': [{'name': 'Mirtoselect', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Male subjects (BMI \\> 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.\n\nVolunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days.', 'armGroupLabels': ['Blaeberry concentrated caspule', 'Placebo capsules containing lactose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB21 9SB', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'University of Aberdeen Rowett Institute of Nutrition and Health', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Nigel Hoggard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen Rowett Institute of Nutrition and Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}