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

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ClinicalTrials.gov Identifier: NCT00698984
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : January 16, 2009
Sponsor:
Information provided by:
DSM Nutritional Products, Inc.

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date January 16, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck [ Time Frame: Baseline and after 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    30 mg BONISTEIN(R) 150 ug Vitamin K1 800 IU Vitamin D3 1000 mg PUFA 500 mg Calcium
    Intervention: Dietary Supplement: BONISTEIN(R) bone blend
  • Placebo Comparator: 2
    500 mg Calcium
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Age 45 (inclusive) to 55 years (inclusive)
  • Race: Caucasian
  • Non-smokers / Smokers up to 10 cigarettes/day
  • Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) >75 IU/ml and 17-estradiol (E2) of < 20 ng/L
  • Years since menopause between 1-3 years
  • Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy
  • Subjects with E2 results within the inclusion criteria range will be assessed on an individual basis if FSH level is less than 75 IU/ml
  • Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject.
  • Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
  • Ability to understand, speak, read and write the English language

Exclusion Criteria:

  • T-score < -2.5 at total hip and spine (either or both)
  • Suspect lack of compliance
  • BMI > 30 or < 21
  • Use of HRT within the previous 6 months
  • Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months
  • Systematic practice of high intensity exercise
  • Vegetarian nutrition or any other extreme dietary habits
  • Use of dietary supplements while on study, except multi vitamin. No "wash out" period for supplements - must stop before run-in period and refrain until the end of the study.
  • Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0).
  • Total genistein blood concentrations of > 100 ng/ml measured at pre-study examination
  • Known hypersensitivity or allergy to soy, purified isoflavones, peanuts, fish, and/or genistein.
  • Hepatitis screen (serology) positive or not performed
  • Drug screen positive or not performed (at least amphetamines, benzodiazepines, cannabinoides, opiates).
  • Subjects on a weight reduction program or a medically supervised diet
  • Unexplained weight loss or weight gain of more than 5 kg in the three months prior to the study
  • History of liver or pancreas diseases
  • Cardiovascular diseases, even AV-block I0 (PQ time > 220 ms) and QTc time > 450 ms
  • History of breast cancer, endometrial cancer and other malignancy except basal and squamous cell skin cancer
  • History of thromboembolism or deep venous thrombosis
  • Any fractures within one year except for fingers, toes and facial bones
  • Subjects with susceptibility for fractures as a history of being a faller
  • Endometrial thickness > 6 mm
  • Endometrial polyps
  • Untreated hypo- or hyperthyroidism
  • Insulin-dependent diabetes mellitus, Crohn's Disease, Cushing Disease etc.
  • Any condition which might interfere with absorption of the investigational product (e.g. malabsorption syndrome)
  • Co-medication: Anticoagulants, parathyroid hormones, corticosteroids, thiazide diuretic
  • Subjects who, during the previous 24 months, received a total fee payment greater than 5'000 USD for participation in biomedical research
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698984
Other Study ID Numbers  ICMJE GEN/BLEND-06.06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P. Heaney, Creighton University Medical Center
Study Sponsor  ICMJE DSM Nutritional Products, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert P Heaney, MD Creighton University Medical Center - Osteoporosis Research Center
PRS Account DSM Nutritional Products, Inc.
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP