Osteoporosis Clinical Trial
Official title:
Pilot Study To Investigate The Effect Of Bonistein(R) Bone Blend Containing Genistein, Polyunsaturated Fatty Acids (N-3 PUFAS) And Vitamins K1 And D3 On Bone Mineral Density (BMD), Bone Mineral Content (BMC) And Biomarkers Of Bone Health In Early Postmenopausal Women
The purpose of this study is to obtain information about the effect of a combination of genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy postmenopausal women. In addition, safety and tolerability will be investigated.
Osteoporosis is the most frequent disease of the skeletal system with approximately one
third of all postmenopausal women being currently affected in the USA and in Europe. The
role of nutrition in bone health has been increasingly recognized in the last couple of
years. In particular nutrients such as isoflavones, vitamins D and K as well as
polyunsaturated fatty acids (PUFA) have been implicate in bone health recently.
The DSM Nutritional Products Ltd product BONISTEIN(R) is a synthetic genistein. Its genistin
aglycone purity is above 99 % and the appearance is a beige crystal.
In addition to the primary and secondary outcomes, body composition, genistein plasma
levels, diet and physical activity are assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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