Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 2:34 PM
Study NCT ID:
NCT00661856
Status:
COMPLETED
Last Update Posted:
2008-04-21
First Post:
2008-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D030262', 'term': 'Soybean Proteins'}, {'id': 'D019833', 'term': 'Genistein'}, {'id': 'C004742', 'term': 'daidzein'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-17', 'studyFirstSubmitDate': '2008-04-17', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Physical Performance Indices', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Soy Isoflavones, Bone Mineral Density, Post menopausal women'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '15167308', 'type': 'BACKGROUND', 'citation': 'Gallagher JC, Satpathy R, Rafferty K, Haynatzka V. The effect of soy protein isolate on bone metabolism. Menopause. 2004 May-Jun;11(3):290-8. doi: 10.1097/01.gme.0000097845.95550.71.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.', 'detailedDescription': 'Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.\n\nThe aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 55-75 years of age\n* at least 7 years post menopausal either spontaneous or surgical\n\nExclusion Criteria:\n\n* must not have used estrogen for atleast 2 months prior to entering study\n* must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids\n* osteoporosis (T-score\\<-2.5)\n* BMI \\<18 or \\>34'}, 'identificationModule': {'nctId': 'NCT00661856', 'acronym': 'SoyPTI', 'briefTitle': 'Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'The Effect of Increased Soy Protein Intake on Bone Metabolism', 'orgStudyIdInfo': {'id': '0012254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Soy Protein group 25g of Soy protein with no Isoflavones', 'interventionNames': ['Dietary Supplement: Soy protein']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones', 'interventionNames': ['Dietary Supplement: Soy protein']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': '25g of Milk protein', 'interventionNames': ['Dietary Supplement: Soy protein']}], 'interventions': [{'name': 'Soy protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['genistein, daidzein, glycetein'], 'description': '25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'J C Gallagher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solae, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'J C Gallagher', 'oldOrganization': 'Creighton University Medical Center'}}}}