Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04720833
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dried Plum on Bone and Markers of Bone Status in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D002118', 'term': 'Calcium'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assign to one of the arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone biomarkers', 'timeFrame': 'changes from baseline to 3 months', 'description': 'TRAP5b, BAP, CTX, P1NP'}], 'secondaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': 'changes from baseline to 12 months', 'description': 'BMD by DXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prunes', 'dried plum', 'nutrition', 'bone'], 'conditions': ['Osteoporosis', 'Osteopenia']}, 'referencesModule': {'references': [{'pmid': '34714130', 'type': 'DERIVED', 'citation': 'Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.', 'detailedDescription': 'To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.\n\nEvaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men (50-79 year-old)\n\nExclusion Criteria:\n\n* endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism\n* Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician\n* subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.\n* body mass index (BMI) \\<18 and \\>30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.\n* If subjects smoke 20 cigarettes or more per day, they will be excluded.\n* Men who regularly consume dried plum or prune juice will not be accepted into the study.'}, 'identificationModule': {'nctId': 'NCT04720833', 'briefTitle': 'Effect of Dried Plum on Bone and Markers of Bone Status in Men', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Effect of Dried Plum on Bone and Markers of Bone Status in Men', 'orgStudyIdInfo': {'id': '2521098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dried plum (100 g dried plum)', 'description': 'Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily', 'interventionNames': ['Dietary Supplement: dried plum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Calcium and vitamin D', 'description': 'Participants will receive 500 mg calcium and 300 IU vitamin D daily', 'interventionNames': ['Dietary Supplement: Calcium and vitamin D']}], 'interventions': [{'name': 'dried plum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dried plum', 'armGroupLabels': ['dried plum (100 g dried plum)']}, {'name': 'Calcium and vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Calcium and vitamin D supplement', 'armGroupLabels': ['Calcium and vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'School of Exercise and Nutritional Sciences', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Shirin Hooshmand, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shirin Hooshmand', 'investigatorAffiliation': 'San Diego State University'}}}}