None listed
Conditions
Interventions
Dietary Supplement : Eligible postmenopausal women with osteopenia (n=137) will be randomly assigned to a dried plum group (100 g/d plus 800 IU vitamin D and 600 mg elemental calcium
n=74) or a control group (800 IU vitamin D and 600 mg elemental calcium
n=63)
Sponsors
Gyeongsang National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Postmenopausal women with osteopenia (BMD T-scores between -1.0 and -2.5 at the femoral neck or spine and a 10-year probability of hip fracture < 3% or a 10-year probability of major osteoporotic fracture < 20%) aged 50-75 years who have not been on hormone replacement therapy for at least 3 months before initiation of the study [For the calculation method of the inclusion criteria, refer to the FRAX website (Sheffield.ac.uk).] 2) The inclusion criteria for hypersensitivity reaction of the dried plum are as follows; - women who clearly recognizes herself as resistant to dried plum - women who is not aware of her own resistance to dried plum, or women who think she is resistant to dried plum [To help more women participate in the study successfully, we will gradually increase the intake of dried plums over a 12-month period to reduce the adverse effect that can occur on maximum capacity (100 g/d).]
Exclusion criteria
Exclusion criteria: 1) Women with a current use of any prescription medications known to alter bone and Ca metabolism. 2) Women with abnormal calcium and phosphate. 3) Women with low vitamin D with elevated PTH. 4) Women on calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within 3 months of the start of the study. 5) Women whose BMD t-score is > 2.5 standard deviation of the mean. 6) Women with metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases. (Stable CVD or diabetes won’t be excluded as they are well-controlled and do not cause symptoms) (Chronic diseases are defined as to chronic disease that may influence bone function e.g. renal disease with eGFR<30 ml/min) 7) Women who regularly consumed dried plum or prune juice. 8) Women with known intolerances to prunes. 9) Women who have particular food allergies. 10) Women who do not have the national health insurance. 11) Women who smoke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of BMD of lumbar spine, forearm, hip and total body using dual-energy X-ray absorptiometry (DXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements of serum vitamin D, serum calcium, serum phosphate, s-CTx and s-P1NP | — |
Countries
Korea, Republic of
Contacts
Public ContactMinkyung Je
Gyeongsang National University
Outcome results
None listed