NCT00698984

Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BONISTEIN(R) bone blend	2 Capsules per day over a period of 6 months
DIETARY_SUPPLEMENT	Placebo	2 capsules per day over a period of 6 months

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-06-17
• Last updated: 2009-01-16

Locations

1 site across 1 country: United States