Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT01881204
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hesperidin and Bone Health in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': 'D006569', 'term': 'Hesperidin'}], 'ancestors': [{'id': 'D044950', 'term': 'Flavanones'}, {'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'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elimination of 41Calcium in Urine.', 'timeFrame': '50 days', 'description': 'Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hesperidin', 'Osteoporosis', 'Bone Loss'], 'conditions': ['Osteoporosis, Postmenopausal']}, 'referencesModule': {'references': [{'pmid': '26751193', 'type': 'DERIVED', 'citation': 'Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.', 'detailedDescription': 'Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.\n\nHesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women at least 4 years postmenopausal\n\nExclusion Criteria:\n\n* Medications affecting bone resorption'}, 'identificationModule': {'nctId': 'NCT01881204', 'acronym': 'Hesperidin', 'briefTitle': 'Hesperidin and Bone Health in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Hesperidin and Bone Health in Postmenopausal Women', 'orgStudyIdInfo': {'id': '10.21.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hesperidin and Calcilock', 'description': 'Subjects will consume 4 cookies containing Hesperidin and Calcilock.', 'interventionNames': ['Dietary Supplement: Hesperidin and Calcilock']}, {'type': 'EXPERIMENTAL', 'label': 'Hesperidin', 'description': 'Subjects will consume 4 cookies containing Hesperidin, 552mg, daily', 'interventionNames': ['Dietary Supplement: Hesperidin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects will consume 4 cookies daily without Hesperidin or Calcilock.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Hesperidin and Calcilock', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).', 'armGroupLabels': ['Hesperidin and Calcilock']}, {'name': 'Hesperidin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hesperidin (552mg) will be administered in the form of cookies (biscuit).', 'armGroupLabels': ['Hesperidin']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cookies without Hesperidin or Calcilock added.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Connie M Weaver, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}, {'name': 'Berdine R Martin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestec Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Berdine Martin', 'investigatorAffiliation': 'Purdue University'}}}}