Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 4:40 AM
Study NCT ID:
NCT01305434
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2011-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mulberry Leaf Extract and Blood Glucose Control in Diabetics
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in 2 hour post prandial blood glucose', 'timeFrame': '6 weeks', 'description': 'Success would be a change in pc glucose of -1.5 units (SI) greater than 70% of the time or in more than 70% of subject, and no increased incidence of hypoglycemia with the intervention'}], 'secondaryOutcomes': [{'measure': 'number of subjects with adverse changes in creatinine, AST, ALT, and blood pressure due to intervention', 'timeFrame': '6 weeks', 'description': 'Because mulberry leaf tea has been shown to contain cadmium which can have renal or hepatotoxic effects, renal function, liver function, and blood pressure will be monitored.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus type 2', 'mulberry leaf extract', 'post prandial blood glucose'], 'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '15386927', 'type': 'BACKGROUND', 'citation': 'Miyahara C, Miyazawa M, Satoh S, Sakai A, Mizusaki S. Inhibitory effects of mulberry leaf extract on postprandial hyperglycemia in normal rats. J Nutr Sci Vitaminol (Tokyo). 2004 Jun;50(3):161-4. doi: 10.3177/jnsv.50.161.'}, {'pmid': '20098579', 'type': 'BACKGROUND', 'citation': 'Park JM, Bong HY, Jeong HI, Kim YK, Kim JY, Kwon O. Postprandial hypoglycemic effect of mulberry leaf in Goto-Kakizaki rats and counterpart control Wistar rats. Nutr Res Pract. 2009 Winter;3(4):272-8. doi: 10.4162/nrp.2009.3.4.272. Epub 2009 Dec 31.'}, {'pmid': '14637259', 'type': 'BACKGROUND', 'citation': 'Andallu B, Varadacharyulu NCh. Antioxidant role of mulberry (Morus indica L. cv. Anantha) leaves in streptozotocin-diabetic rats. Clin Chim Acta. 2003 Dec;338(1-2):3-10. doi: 10.1016/s0009-8981(03)00322-x.'}, {'pmid': '15979095', 'type': 'BACKGROUND', 'citation': 'Park MY, Lee KS, Sung MK. Effects of dietary mulberry, Korean red ginseng, and banaba on glucose homeostasis in relation to PPAR-alpha, PPAR-gamma, and LPL mRNA expressions. Life Sci. 2005 Nov 12;77(26):3344-54. doi: 10.1016/j.lfs.2005.05.043. Epub 2005 Jun 23.'}, {'pmid': '19434497', 'type': 'BACKGROUND', 'citation': 'Naowaboot J, Pannangpetch P, Kukongviriyapan V, Kongyingyoes B, Kukongviriyapan U. Antihyperglycemic, antioxidant and antiglycation activities of mulberry leaf extract in streptozotocin-induced chronic diabetic rats. Plant Foods Hum Nutr. 2009 Jun;64(2):116-21. doi: 10.1007/s11130-009-0112-5.'}, {'pmid': '16611383', 'type': 'BACKGROUND', 'citation': 'Oku T, Yamada M, Nakamura M, Sadamori N, Nakamura S. Inhibitory effects of extractives from leaves of Morus alba on human and rat small intestinal disaccharidase activity. Br J Nutr. 2006 May;95(5):933-8. doi: 10.1079/bjn20061746.'}, {'pmid': '17071014', 'type': 'BACKGROUND', 'citation': 'Hansawasdi C, Kawabata J. Alpha-glucosidase inhibitory effect of mulberry (Morus alba) leaves on Caco-2. Fitoterapia. 2006 Dec;77(7-8):568-73. doi: 10.1016/j.fitote.2006.09.003. Epub 2006 Sep 22.'}, {'pmid': '16960168', 'type': 'BACKGROUND', 'citation': 'Zhong L, Furne JK, Levitt MD. An extract of black, green, and mulberry teas causes malabsorption of carbohydrate but not of triacylglycerol in healthy volunteers. Am J Clin Nutr. 2006 Sep;84(3):551-5. doi: 10.1093/ajcn/84.3.551.'}, {'pmid': '17303787', 'type': 'BACKGROUND', 'citation': 'Mudra M, Ercan-Fang N, Zhong L, Furne J, Levitt M. Influence of mulberry leaf extract on the blood glucose and breath hydrogen response to ingestion of 75 g sucrose by type 2 diabetic and control subjects. Diabetes Care. 2007 May;30(5):1272-4. doi: 10.2337/dc06-2120. Epub 2007 Feb 15. No abstract available.'}, {'pmid': '11718678', 'type': 'BACKGROUND', 'citation': 'Andallu B, Suryakantham V, Lakshmi Srikanthi B, Reddy GK. Effect of mulberry (Morus indica L.) therapy on plasma and erythrocyte membrane lipids in patients with type 2 diabetes. Clin Chim Acta. 2001 Dec;314(1-2):47-53. doi: 10.1016/s0009-8981(01)00632-5.'}, {'pmid': '16939361', 'type': 'BACKGROUND', 'citation': 'Nookabkaew S, Rangkadilok N, Satayavivad J. Determination of trace elements in herbal tea products and their infusions consumed in Thailand. J Agric Food Chem. 2006 Sep 6;54(18):6939-44. doi: 10.1021/jf060571w.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov/ct2/show/NCT00795704?term=mulberry+leaf+extract&rank=1', 'label': 'Another trial looking at a similar question (completed but not published at the time of this protocol)'}]}, 'descriptionModule': {'briefSummary': 'Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries. Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by measuring blood glucose two hours after eating a meal and taking a capsule containing either mulberry leaf extract or a placebo.', 'detailedDescription': 'Patients will participate in a double blind randomized cross over trial for 6 weeks. Four 2 weeks, half of the type 2 diabetic patients will receive mulberry leaf capsules three times per day with meals (made from Mulberry Zuccarin tablets - New Nordic, 400 mg of mulberry leaf extract per tablet) and half will receive placebo capsules. Following a one week wash out period, the treatments administered to each group will be reversed for the next 2 weeks, and data will continue to be gathered for a final wash out week. Patients will keep a diary of food, exercise, and fasting glucose each morning as well as at least one 2 hour pc glucose each day. Weight, hemoglobin A1C, liver function tests, and renal function tests will be done at baseline and at the end of the 6 weeks. As well, blood pressure will be monitored when the 2 weekly batches of medication are distributed, and at the end of the 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* baseline hemoglobin A1C greater than or equal to 7.5 or fasting glucose greater than 7 (SI units)\n\nExclusion Criteria:\n\n* on insulin\n* history of hepatic or renal disease\n* pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT01305434', 'briefTitle': 'Mulberry Leaf Extract and Blood Glucose Control in Diabetics', 'organization': {'class': 'INDIV', 'fullName': 'Craig, Nancy, M.D.'}, 'officialTitle': 'Randomized Double Blind Cross Over Trial to Examine the Effect of Mulberry Leaf Extract on Post Prandial Glucose in Type 2 Diabetics', 'orgStudyIdInfo': {'id': 'MLE-DM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placebo then mulberry leaf', 'description': 'These patients receive placebo for two weeks, then 1 week washout, then two weeks of mulberry leaf extract.', 'interventionNames': ['Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose']}, {'type': 'OTHER', 'label': 'Mulberry leaf then placebo', 'description': 'These patients receive mulberry leaf extract for two weeks, then 1 week washout, then two weeks of placebo.', 'interventionNames': ['Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose']}], 'interventions': [{'name': 'Mulberry leaf extract effect on post prandial blood glucose', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)'], 'description': "Mulberry leaf extract (400 mg, Mulberry Zuccarin, New Nordic) or placebo will be administered with meals to type 2 diabetics. Half the patients will receive mulberry leaf extract for the first two weeks and half will receive placebo. Following a one week wash out period, the interventions will be reversed for another 2 weeks, followed by a final wash out period. Subjects will keep diaries of food, exercise, daily fasting glucose, and at least one 2 hour pc glucose per day for the 6 weeks of the trial.\n\nBaseline renal function blood work and urine, liver function blood work, hemoglobin A1C, weight, and blood pressure will be done. These will be repeated at the end of each subject's 6 weeks in the trial. In addition, blood pressure will be checked with the distribution of the each 2 week batch of medications.", 'armGroupLabels': ['Mulberry leaf then placebo', 'Placebo then mulberry leaf']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5B 2Y1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Hope Medical Clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Nancy V Craig, MDCM', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William R Craig, MD CM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Craig, Nancy, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Nancy Craig', 'investigatorFullName': 'Nancy Craig', 'investigatorAffiliation': 'Craig, Nancy, M.D.'}}}}