Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 5:14 PM
Study NCT ID:
NCT01330550
Status:
UNKNOWN
Last Update Posted:
2011-04-07
First Post:
2011-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-06', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'up to 8 weeks', 'description': 'The investigators expect the HbA1c will be greatly improved at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'Insulin, Fasting Glucose,Ketone Body, Fructosamine.', 'timeFrame': '8 weeks', 'description': 'The investigators expect the following data will be improved at the end of the study:Insulin, Fasting Glucose, Ketone Body, Fructosamine.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High fiber sugar free biscuit', 'pre-diabetics'], 'conditions': ['Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'The increase in diabetic population of the world is among the top ten causes of death; with diabetes always high on the list of causes of death. Diabetes is always relative to other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease).\n\nThe eating habits and patterns of the diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber and low sugar dietary intake can significantly reduce the incidence of diabetes.\n\nThe purpose of this study is to investigate the effect of high fiber sugar-free biscuits in regulating blood glucose in pre-diabetic subjects.\n\nThe study will be conducted in three periods:\n\nPeriod-I:\n\nThe recruitment of 60 pre-diabetic subjects:\n\nSubjects of blood glucose levels "Impaired fasting glucose; IFG": fasting blood glucose ≧ 100 mg / dL, \\< 126 mg / dL or "Impaired glucose tolerance; IGT": 2 hours postprandial blood glucose ≧ 140mg/dL, \\< 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus (HbA1c \\< 9%).\n\nIn addition to perform pre-test, all subjects also need to complete nutrition counseling and nutrition education .\n\nAll 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group)\n\nThe period-II:\n\nDuration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.\n\nGroup-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30 subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of fiber) daily.\n\nPost-period:\n\nBlood samples of all 60 subjects will be collected to compare with period-I and period-II at the first day of 9th week.\n\nReport of expectation:\n\nThe purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.', 'detailedDescription': 'The increase in diabetic population of the world, is among the top ten causes of death; with diabetes always a top cause of death. Diabetes is always related with other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease).\n\nThe eating habits and patterns of diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber rand low sugar dietary intake can significantly reduce the incidence of diabetes.\n\nThe purpose of this study is to investigate the effect of high fiber sugar-free biscuits in regulating blood glucose in pre-diabetic subjects.\n\nThe study will be conducted in three periods:\n\nPeriod-I:\n\nThe recruitment of 60 pre-diabetic subjects:\n\nSubjects of blood glucose levels "Impaired fasting glucose; IFG": fasting blood glucose ≧ 100 mg / dL, \\< 126 mg/dL or "Impaired glucose tolerance; IGT": 2 hours postprandial blood glucose ≧ 140mg/dL, \\< 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus (HbA1c \\< 9%) .\n\nIn addition to perform pre-test, all subjects also need to complete nutrition counseling and nutrition education .\n\nAll 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group) , Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group)\n\nBlood samples will be collected from all 60 subjects to investigate:\n\nHbA1c, Blood sugars(Fasting and 2 hours after meal), Insulin, Fructosamine, SGOT,SGPT,ALK-P,TOTAL PROTEIN, Albumin, Globulin, Ketone, Bun,Creatinine, Cholesterol,TG,LDl,HDL, WBC,RBC,Hgb,Hct,M.C.V.,MCH,MCHC,Platelet.\n\nThe period-II:\n\nDuration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group), All 30 subjects consume 3 serving of Low-fiber, normal sugar biscuits daily.\n\nGroup-2, 30 subjects,(Experimental group, high fiber and sugar free biscuit group) All 30 subjects consume 3 serving of high-fiber, and sugar free biscuits(containing 16 grams of fiber) daily.\n\nPost-period:\n\nBlood samples of all 60 subjects will be collected to compare with period-I and period-II at the first day of 9th week.\n\nReport of expectation:\n\nThe purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fasting blood glucose ≧100mg/dL and \\< 126mg/dL\n* Impaired glucose tolerance; IGT\n* HbA1c \\< 9%\n\nExclusion Criteria:\n\n* DM patients\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01330550', 'briefTitle': 'Effect of High Fiber and Sugar Free Biscuits in Prediabetics Population', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Effect of High Fiber and Sugar Free Biscuits in Diabetics Population', 'orgStudyIdInfo': {'id': 'DMR99-IRB-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high fiber sugar free biscuit.', 'description': 'High fiber sugar free biscuit will regulate Blood sugars.', 'interventionNames': ['Dietary Supplement: High fiber sugar free biscuit']}], 'interventions': [{'name': 'High fiber sugar free biscuit', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Taiwan IMeI high fiber sugar free biscuit'], 'description': 'Dosage form:Biscuit, Dosage:1.94gram fiber/slice, Frequency:9 slices/meal;3 times/day. Duration:8 weeks', 'armGroupLabels': ['high fiber sugar free biscuit.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Huang Hui-Ying', 'role': 'CONTACT', 'email': 'hyhuang@mail.cmu.edu.tw', 'phone': '886-4-22053366', 'phoneExt': '7506'}], 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Huang Hui-Ying', 'role': 'CONTACT', 'email': '<hyhuang@mail.cmu.edu.tw>', 'phone': '886-4-22053366', 'phoneExt': '7506'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hui-Ying, Huang/associate professor', 'oldOrganization': 'China Medical University'}}}}