Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT04167150
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2019-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tart Cherry Supplementation and Women's Bone Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized dose-response pre-test, post-test study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone-specific alkaline phosphatase (U/L)', 'timeFrame': 'Change from baseline to final visits (3 month intervention)', 'description': 'Bone formation marker'}, {'measure': 'Tartrate resistant acid phosphatase (U/L)', 'timeFrame': 'Change from baseline to final visits (3 month intervention)', 'description': 'Bone resorption marker'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'Change from baseline to final visits (3 month intervention)', 'description': 'Marker of inflammation'}, {'measure': 'Thiobarbituric acid reactive species (TBARS) (U/L)', 'timeFrame': 'Change from baseline to final visits (3 month intervention)', 'description': 'Marker of oxidative stress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'biomarkers', 'tart cherry', 'functional food'], 'conditions': ['Osteoporosis, Postmenopausal', 'Osteoporosis, Age-Related']}, 'descriptionModule': {'briefSummary': 'In spite of aggressive approaches to prevent and treat osteoporosis, it remains one of the most costly and debilitating diseases associated with aging. The pursuit of alternative approaches for preventing bone loss has included the investigation of a number of promising plant-based foods that can be incorporated into the diet. This project is an extension of our pre-clinical studies with tart cherry, designed to determine whether the findings from our animal study can be extended to humans. Thus, the purpose of this project is to investigate the dose-dependent effect of tart cherry juice consumption on biomarkers of bone metabolism in women, aged 65-80 years. The hypothesis to be tested is that three months of tart cherry supplementation will improve bone biomarkers in a dose-dependent manner. Moreover, these improvements in bone metabolism will correspond to a decrease in markers of inflammation and oxidative stress.', 'detailedDescription': 'Tart cherries are an excellent course of phenolic compounds and anthocyanins, and in pre-clinical studies have been shown to prevent age-related bone loss. Based on these findings, this pilot study was designed to investigate the effects of three months of tart cherry juice supplementation on improving markers of oxidative stress and bone metabolism in older women. Women (n=30), aged 65-80 yrs, will be recruited for the study and randomly assigned to one of two doses of tart cherry juice (8 or 16 fl oz) per day prepared from a Montmorency cherry concentrate (King Orchards, Central Lake, MI). Study participants will complete two study visits to the Nutritional Sciences Clinical Research Center. At the first visit, informed consent will be obtained and relevant medical history and anthropometric measures will be taken by the research team. A blood draw will be performed to assess baseline, biochemical markers of bone metabolism and inflammation as well as indicators of oxidative status. A physical activity and food frequency questionnaire will be completed by each study participant. Whole body, hip and spine bone density (DXA) scan will be performed by certified bone densitometrist. A 3-month final visit will be scheduled for all study participants in which most of the procedures described at baseline (except DXA) will be repeated. Change in primary and secondary outcome measures (i.e., bone, inflammation and oxidative stress biomarkers) will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, 65-80 years of age\n* Capacity to give informed consent\n\nExclusion Criteria:\n\n* Hormone replacement therapy in the 3 months prior to starting the study\n* Bisphosphonates in the 3 months prior to starting the study\n* Raloxifene in the 3 months prior to starting the study\n* Intermittent parathyroid hormone in the 3 months prior to starting the study\n* Growth hormone or steroids in the 3 months prior to starting the study\n* Osteoporosis\n* Renal disease\n* Cancer\n* Cardiovascular disease\n* Diabetes\n* Respiratory disease\n* Gastrointestinal diseases\n* Liver disease\n* Other chronic conditions that could affect bone metabolism'}, 'identificationModule': {'nctId': 'NCT04167150', 'briefTitle': "Tart Cherry Supplementation and Women's Bone Health Study", 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Effect of Montmorency Tart Cherry Supplementation on Bone Biomarkers in Women Aged 65-80 Years: A Pilot Study', 'orgStudyIdInfo': {'id': 'CMI2017-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 1', 'description': 'Participants consume 8 fl oz of tart cherry juice per day.', 'interventionNames': ['Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'Participants consume 2 x 8 fl oz of tart cherry juice per day.', 'interventionNames': ['Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)']}], 'interventions': [{'name': 'tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants were instructed to reconstitute the tart cherry juice concentrate in 8 fl oz of water and consume either 1x or 2x daily for 3 months.', 'armGroupLabels': ['Dose 1', 'Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University - Nutritional Sciences', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cherry Marketing Institute Research Committee', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition', 'investigatorFullName': 'Brenda Smith', 'investigatorAffiliation': 'Oklahoma State University'}}}}