The effects of a 12-month dried plum consumption on bone mineral density and bone turnover markers in Korean postmenopausal women with osteopenia: a randomized, open-labeled, placebo-controlled study

Gyeongsang National University Hospital0 个研究点目标入组 137 人开始时间: 待定最近更新: 2023年3月6日

适应症

试验速览

暂无简介。

•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).]

•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.

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