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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
70
2 Capsules per day over a period of 6 months
2 capsules per day over a period of 6 months
Creighton University Medical Center - Osteoporosis Research Center
Omaha, Nebraska, United States
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck
Time frame: Baseline and after 6 months
BMD/BMC on whole body, Ward's Triangle, total hip, and (inter)trochanter Bone resorption markers: DPD, NTX, RANKL/OPG Bone formation markers: bALP, OC, ucOC
Time frame: Baseline and after 3 and 6 months (bone markers)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.