[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06184646":3,"trial-entities:NCT06184646":89,"trial-summary:NCT06184646":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":62,"locations":66,"central_contacts":79,"overall_officials":84,"references":87,"see_also_links":88},"NCT06184646","HS-2023-0243","Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women","Effect of Calcium and Vitamin D Supplements and\u002For Prunes on Bone Health","RECRUITING","2028-12","2026-06","2026-07-01","2024-03-15","San Diego State University","OTHER",false,"The objective of this study is to examine if calcium and vitamin D supplements and\u002For prune can prevent bone loss in postmenopausal women.","Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.",[19],"Bone Disease, Metabolic",[21,22,23],"Osteopenia","Prune","Functional food","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},200,"ESTIMATED",[32],{"type":33,"name":22,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","30 g of prune\u002Fday",[36],"30 g prune\u002Fday",[38],{"measure":39,"description":40,"timeFrame":41},"Changes from baseline in bone mineral density at 12 and 24 months","bone mineral density as assessed by dual energy x-ray absorptiometry","Baseline, 12 months, and 24 months",[43,46],{"measure":44,"description":45,"timeFrame":41},"Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months","bone specific alkaline phosphatase (BAP) as assessed with ELISA",{"measure":47,"description":48,"timeFrame":41},"Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months","tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA","FEMALE",null,{"inclusion":52,"exclusion":56,"raw_text":61},[53,54,55],"Postmenopausal","BMD t-score is between 0.5 and 2 SD below the mean","Not on hormone replacement therapy (HRT) and\u002For other pharmacological agents known to affect bone for at least three months prior to initiation of the study",[57,58,59,60],"Women whose BMD t-score at any site falls below 2.5 SD of the mean","Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism","Subjects who smoke cigarettes or vape","Regular consumption of dried plum or prune juice","Inclusion Criteria:\n\n* Postmenopausal\n* BMD t-score is between 0.5 and 2 SD below the mean\n* Not on hormone replacement therapy (HRT) and\u002For other pharmacological agents known to affect bone for at least three months prior to initiation of the study\n\nExclusion Criteria:\n\n* Women whose BMD t-score at any site falls below 2.5 SD of the mean\n* Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism\n* Subjects who smoke cigarettes or vape\n* Regular consumption of dried plum or prune juice",[63,64,65],"CHILD","ADULT","OLDER_ADULT",[67],{"facility":13,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":76},"San Diego","California","92182-7251","United States",[73],{"name":74,"role":75},"Shirin Hooshmand, PhD, RD","CONTACT",{"lat":77,"lon":78},32.71571,-117.16472,[80],{"name":81,"role":75,"phone":82,"email":83},"Shirin Hooshmand, PhD","619-594-6823","shooshmand@sdsu.edu",[85],{"name":81,"affiliation":13,"role":86},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[21],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study planning to enroll 200 postmenopausal women. Participants will be randomly assigned to one of two groups: one receiving prunes and one not.","completed","Prunes for Bone Health in Postmenopausal Women","This study is looking at whether eating prunes, along with calcium and vitamin D supplements, can help prevent bone loss in women after menopause. Researchers want to find out if a small amount of prunes (30 grams daily) can make a difference in your bone mineral density (a measure of bone strength). You might be able to join if you are a postmenopausal woman with some bone loss, but not severe, and are not currently taking hormone replacement therapy or other bone-affecting medications. The study will measure changes in your bone mineral density over two years to see if the prune intervention is successful. The current status of this study is unclear.","Participants will be followed for 24 months after starting the study interventions.",112,"You would take daily supplements for 24 months. You would have blood samples, physical activity recalls, food records, and bone scans (DXA and pQCT) at the start, 12 months, and 24 months.","Not stated in the trial record.",[22],"v2"]