Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-24 @ 7:31 AM
Study NCT ID:
NCT00841503
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2009-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Buckwheat's Glucose Lowering Potential
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D013549', 'term': 'Sweetening Agents'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine glucose-lowering potential of the buckwheat bioactive compound during acute phase testing in volunteers with Type 2 diabetes', 'timeFrame': '3 hour testing'}], 'secondaryOutcomes': [{'measure': 'determine bioavailability of buckwheat bioactive compounds', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['functional food study'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '14640572', 'type': 'BACKGROUND', 'citation': 'Kawa JM, Taylor CG, Przybylski R. Buckwheat concentrate reduces serum glucose in streptozotocin-diabetic rats. J Agric Food Chem. 2003 Dec 3;51(25):7287-91. doi: 10.1021/jf0302153.'}, {'pmid': '11893482', 'type': 'BACKGROUND', 'citation': 'Qureshi AA, Sami SA, Khan FA. Effects of stabilized rice bran, its soluble and fiber fractions on blood glucose levels and serum lipid parameters in humans with diabetes mellitus Types I and II. J Nutr Biochem. 2002 Mar;13(3):175-187. doi: 10.1016/s0955-2863(01)00211-x.'}, {'pmid': '12198000', 'type': 'BACKGROUND', 'citation': 'Knekt P, Kumpulainen J, Jarvinen R, Rissanen H, Heliovaara M, Reunanen A, Hakulinen T, Aromaa A. Flavonoid intake and risk of chronic diseases. Am J Clin Nutr. 2002 Sep;76(3):560-8. doi: 10.1093/ajcn/76.3.560.'}, {'pmid': '1656395', 'type': 'BACKGROUND', 'citation': 'Thompson LU, Robb P, Serraino M, Cheung F. Mammalian lignan production from various foods. Nutr Cancer. 1991;16(1):43-52. doi: 10.1080/01635589109514139.'}, {'pmid': '2833261', 'type': 'BACKGROUND', 'citation': 'Larner J, Huang LC, Schwartz CF, Oswald AS, Shen TY, Kinter M, Tang GZ, Zeller K. Rat liver insulin mediator which stimulates pyruvate dehydrogenase phosphate contains galactosamine and D-chiroinositol. Biochem Biophys Res Commun. 1988 Mar 30;151(3):1416-26. doi: 10.1016/s0006-291x(88)80520-5.'}, {'pmid': '2517463', 'type': 'BACKGROUND', 'citation': 'Larner J, Huang LC, Suzuki S, Tang G, Zhang C, Schwartz CF, Romero G, Luttrell L, Kennington AS. Insulin mediators and the control of pyruvate dehydrogenase complex. Ann N Y Acad Sci. 1989;573:297-305. doi: 10.1111/j.1749-6632.1989.tb15006.x. No abstract available.'}, {'pmid': '8939003', 'type': 'BACKGROUND', 'citation': 'Varela-Nieto I, Leon Y, Caro HN. Cell signalling by inositol phosphoglycans from different species. Comp Biochem Physiol B Biochem Mol Biol. 1996 Oct;115(2):223-41. doi: 10.1016/0305-0491(96)00087-9.'}, {'pmid': '9134421', 'type': 'BACKGROUND', 'citation': 'Field MC. Is there evidence for phospho-oligosaccharides as insulin mediators? Glycobiology. 1997 Mar;7(2):161-8. doi: 10.1093/glycob/7.2.161-d. No abstract available.'}, {'pmid': '9611774', 'type': 'BACKGROUND', 'citation': 'Jones DR, Varela-Nieto I. The role of glycosyl-phosphatidylinositol in signal transduction. Int J Biochem Cell Biol. 1998 Mar;30(3):313-26. doi: 10.1016/s1357-2725(97)00144-1.'}, {'pmid': '10480610', 'type': 'BACKGROUND', 'citation': 'Oku A, Ueta K, Arakawa K, Ishihara T, Nawano M, Kuronuma Y, Matsumoto M, Saito A, Tsujihara K, Anai M, Asano T, Kanai Y, Endou H. T-1095, an inhibitor of renal Na+-glucose cotransporters, may provide a novel approach to treating diabetes. Diabetes. 1999 Sep;48(9):1794-800. doi: 10.2337/diabetes.48.9.1794.'}, {'pmid': '10954015', 'type': 'BACKGROUND', 'citation': 'Adachi T, Yasuda K, Okamoto Y, Shihara N, Oku A, Ueta K, Kitamura K, Saito A, Iwakura I, Yamada Y, Yano H, Seino Y, Tsuda K. T-1095, a renal Na+-glucose transporter inhibitor, improves hyperglycemia in streptozotocin-induced diabetic rats. Metabolism. 2000 Aug;49(8):990-5. doi: 10.1053/meta.2000.7729.'}, {'pmid': '15792833', 'type': 'BACKGROUND', 'citation': 'Ueta K, Ishihara T, Matsumoto Y, Oku A, Nawano M, Fujita T, Saito A, Arakawa K. Long-term treatment with the Na+-glucose cotransporter inhibitor T-1095 causes sustained improvement in hyperglycemia and prevents diabetic neuropathy in Goto-Kakizaki Rats. Life Sci. 2005 Apr 22;76(23):2655-68. doi: 10.1016/j.lfs.2004.09.038.'}, {'pmid': '10710509', 'type': 'BACKGROUND', 'citation': 'Nawano M, Oku A, Ueta K, Umebayashi I, Ishirahara T, Arakawa K, Saito A, Anai M, Kikuchi M, Asano T. Hyperglycemia contributes insulin resistance in hepatic and adipose tissue but not skeletal muscle of ZDF rats. Am J Physiol Endocrinol Metab. 2000 Mar;278(3):E535-43. doi: 10.1152/ajpendo.2000.278.3.E535.'}, {'pmid': '11170616', 'type': 'BACKGROUND', 'citation': 'Skrabanja V, Liljeberg Elmstahl HG, Kreft I, Bjorck IM. Nutritional properties of starch in buckwheat products: studies in vitro and in vivo. J Agric Food Chem. 2001 Jan;49(1):490-6. doi: 10.1021/jf000779w.'}, {'pmid': '14689721', 'type': 'BACKGROUND', 'citation': 'Bray GA. Evaluation of obesity. Who are the obese? Postgrad Med. 2003 Dec;114(6):19-27, 38. doi: 10.3810/pgm.2003.12.1544.'}, {'pmid': '12671200', 'type': 'BACKGROUND', 'citation': 'Ball GD, McCargar LJ. Childhood obesity in Canada: a review of prevalence estimates and risk factors for cardiovascular diseases and type 2 diabetes. Can J Appl Physiol. 2003 Feb;28(1):117-40. doi: 10.1139/h03-010.'}, {'type': 'BACKGROUND', 'citation': 'Lu C et al. (1992) Proceedings of the 5th International Symposium on Buckwheat; Lin R, Zhou M, Tao Y, Li J, Zhang, Z. Eds; Agriculture Publishing House: Beijing,China; pp 458-464.'}, {'type': 'BACKGROUND', 'citation': 'Wang J et al. (1992) Proceedings of the 5th International Symposium on Buckwheat; Lin R, Zhou M, Tao Y, Li J, Zhang, Z. Eds; Agriculture Publishing House: Beijing, China; pp 465-467.'}, {'type': 'BACKGROUND', 'citation': 'Horbowicz M & Obendorf RL. (1994) Seed Sci Res 4: 385-405.'}, {'pmid': '11093720', 'type': 'BACKGROUND', 'citation': 'Obendorf RL, Steadman KJ, Fuller DJ, Horbowicz M, Lewis BA. Molecular structure of fagopyritol A1 (O-alpha-D-galactopyranosyl-(1 --> 3)-D-chiro-inositol) by NMR. Carbohydr Res. 2000 Oct 6;328(4):623-7. doi: 10.1016/s0008-6215(00)00133-6.'}, {'pmid': '10898633', 'type': 'BACKGROUND', 'citation': 'Steadman KJ, Burgoon MS, Schuster RL, Lewis BA, Edwardson SE, Obendorf RL. Fagopyritols, D-chiro-inositol, and other soluble carbohydrates in buckwheat seed milling fractions. J Agric Food Chem. 2000 Jul;48(7):2843-7. doi: 10.1021/jf990709t.'}, {'pmid': '11284502', 'type': 'BACKGROUND', 'citation': 'Steadman KJ, Fuller DJ, Obendorf RL. Purification and molecular structure of two digalactosyl D-chiro-inositols and two trigalactosyl D-chiro-inositols from buckwheat seeds. Carbohydr Res. 2001 Mar 9;331(1):19-25. doi: 10.1016/s0008-6215(00)00320-7.'}, {'pmid': '15449578', 'type': 'BACKGROUND', 'citation': 'Scheepers A, Joost HG, Schurmann A. The glucose transporter families SGLT and GLUT: molecular basis of normal and aberrant function. JPEN J Parenter Enteral Nutr. 2004 Sep-Oct;28(5):364-71. doi: 10.1177/0148607104028005364.'}]}, 'descriptionModule': {'briefSummary': 'Bioactive components in buckwheat enhance insulin sensitivity in Type 2 diabetes by improving glucose uptake and utilization through a unique mechanism that operates independent of insulin.', 'detailedDescription': "This is a single site, double-blind, randomized, controlled study designed to explore buckwheat's glucose lowering effects in healthy volunteers and volunteers with type 2 diabetes. A total of 24 volunteers consisting of 12 volunteers (healthy and diabetic) per group for both the acute and chronic phases of testing will be recruited through advertisement from the local community.\n\nIn the acute testing phase, volunteers (healthy and diabetic) will be asked to attend 4 visits one week apart for the duration of 3 hours per visit. A fasting blood sample will be collected at each visit. At each visit, all volunteers will consume in random order 1 of the following 4 products: i) crackers containing buckwheat; ii) crackers without buckwheat); iii) 50 mls of oral solution containing glucose; or iv) 50 mls of oral solution containing the sugar substitute Splenda. The crackers will contain equal amounts of available carbohydrates. Blood sampling will occur at 15, 30, 45, 60 minutes, and then every 60 minutes for the remainder of the visit. Sampling (pre and post product consumption) will measure insulin, glucose, and various incretins. Open venous access will be secured after the first sample has been obtained to minimize the number of needle pricks. Total amount of blood obtained will not exceed 30 mls per visit.\n\nIn the chronic testing phase, volunteers (healthy and diabetic) will receive the crackers containing buckwheat for consumption each day for 7 days. Prior to food consumption, a fasting blood sample will be obtained each day and a urine sample will be collected on Days 1, 3, and 7 to assess bioavailability of buckwheat compounds (concentrations in blood and urine), insulin and glucose. Sampling for a lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), liver (ALT), kidney (creatinine), adipose function (adipokines), various incretins, as well as inflammatory status (various cytokines) will be done on Day 1 and Day 7. Total amount of blood obtained will not exceed 30 mls per visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 24 volunteers were recruited from the community; 12 healthy volunteers and 12 volunteers with Type 2 Diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 to 70 years\n* normal glycated hemoglobin (\\<6% healthy, \\<7.5% diabetic)\n* absence of chronic conditions (except Type 2 diabetes)\n* must be able to read and sign consent\n* must be able to comply with protocol requirements\n\nExclusion Criteria:\n\n* allergies to eggs, buckwheat, rice flour, or sugar substitutes (Splenda)\n* acute or chronic conditions (except Type 2 diabetes)\n* blood glucose \\>10mmol/L at beginning of test session\n* medications that affect glycemic control'}, 'identificationModule': {'nctId': 'NCT00841503', 'briefTitle': "Exploring Buckwheat's Glucose Lowering Potential", 'organization': {'class': 'OTHER', 'fullName': 'St. Boniface Hospital'}, 'officialTitle': "A Double-Blind, Randomized, Controlled Study to Determine Buckwheat's Glucose Lowering Effects in Healthy Volunteers and Volunteers With Type 2 Diabetes", 'orgStudyIdInfo': {'id': 'buckwheat study'}}, 'armsInterventionsModule': {'armGroups': [{'label': '12 healthy volunteers', 'description': 'Healthy volunteers are randomized to 1 of 4 products over 4 weekly visits: i)buckwheat crackers;ii)crackers without buckwheat; iii)oral glucose; iv) oral sugar substitute, followed by 7 days of buckwheat crackers.', 'interventionNames': ['Other: buckwheat, rice crackers, glucose, sugar substitute']}, {'label': '12 Participants with Type 2 diabetes', 'description': 'Volunteers with type 2 diabetes are randomized to 1 of 4 products over 4 weekly visits: i)buckwheat crackers;ii)crackers without buckwheat; iii)oral glucose; iv) oral sugar substitute, followed by 7 days of buckwheat crackers.', 'interventionNames': ['Other: buckwheat, rice crackers, glucose, sugar substitute']}], 'interventions': [{'name': 'buckwheat, rice crackers, glucose, sugar substitute', 'type': 'OTHER', 'description': 'crackers contain equal amounts of available carbohydrates; 50 mls of oral solution for both glucose and Splenda', 'armGroupLabels': ['12 Participants with Type 2 diabetes', '12 healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'I.H. Asper Clinical Research Institute', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter C Zahradka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canadian Centre for Agri-Food Research in Health & Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Boniface Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Physiology', 'investigatorFullName': 'Dr.Peter Zahradka', 'investigatorAffiliation': 'St. Boniface Hospital'}}}}