Bone Disease, Metabolic
Conditions
Keywords
Osteopenia, Prune, Functional food
Brief summary
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPrune
30 g of prune/day
Sponsors
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Postmenopausal * BMD t-score is between 0.5 and 2 SD below the mean * Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in bone mineral density at 12 and 24 months | Baseline, 12 months, and 24 months | bone mineral density as assessed by dual energy x-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months | Baseline, 12 months, and 24 months | bone specific alkaline phosphatase (BAP) as assessed with ELISA |
| Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months | Baseline, 12 months, and 24 months | tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA |
Countries
United States
Contacts
CONTACTShirin Hooshmand, PhD
PRINCIPAL_INVESTIGATORShirin Hooshmand, PhD
San Diego State University
Outcome results
None listed