|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | DSM Nutritional Products, Inc. |
|---|---|
| Information provided by: | DSM Nutritional Products, Inc. |
| ClinicalTrials.gov Identifier: | NCT00698984 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Dietary Supplement: BONISTEIN(R) bone blend Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 70 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
30 mg BONISTEIN(R) 150 ug Vitamin K1 800 IU Vitamin D3 1000 mg PUFA 500 mg Calcium
|
Dietary Supplement: BONISTEIN(R) bone blend
2 Capsules per day over a period of 6 months
|
|
2: Placebo Comparator
500 mg Calcium
|
Dietary Supplement: Placebo
2 capsules per day over a period of 6 months
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Nebraska | |
| Creighton University Medical Center - Osteoporosis Research Center | |
| Omaha, Nebraska, United States, 68131 | |
| Principal Investigator: | Robert P Heaney, MD | Creighton University Medical Center - Osteoporosis Research Center |
More Information
| Responsible Party: | Creighton University Medical Center ( Robert P. Heaney ) |
| Study ID Numbers: | GEN/BLEND-06.06 |
| Study First Received: | June 13, 2008 |
| Last Updated: | January 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00698984 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Soy Isoflavones, Bone Mineral Density, Bone Mineral Content, postmenopausal Women, Bone Markers, Bone Health, Phytoestrogens |
|
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |