None(post-menopausal women)
Conditions
Interventions
Ingestion of supplement A for 16 weeks
Ingestion of supplement B for 16 weeks
Ingestion of plasebo for 16 weeks
Sponsors
Kenkoin Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Healthy postmenopausal women ((No period for 1 year or longer by background questionnaire. FSH >=30 mIU/mL, estradiol (E2)<= 10 pg/mL by screening tests) 2.50 to 69 year of age 3.Serum 25(OH)D level a less-than-or-equal-to 20 ng /mL (50 nmol/L) 4.BMI between 18.5 to 24.9 kg/m2 5.Generally healthy in the opinion of the investigators (based on clinical chemistry and hematology) 6.Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1.Current smoker 2.Subjects who are planning to extensively expose one's body to the sun (for example agricultural practice or going on holidays) 3.Serum calcium >2.6 nmol/L 4.Fasting glucose >100 mg /dl 5.Use of HRT within the previous 6 months moker 6.Use of dietary supplements while on study, except multi-vitamins, however must stop before enter the study and refrain until the end of the study 7.Use of Vitamin D supplements 8.Use of high dose Calcium supplements >600 mg 9.Hypertension: higher than 145 / 95 mmHG measured in resting position 10.Treatment for hypertension 11.Subjects with a history of a psychological illness or condition which is likely to interfere with the subject's ability to understand the requirements of the study 12.Systematic practice of high intensity exercise (high intensity sports more than 3 times per week) 13.Any condition that might interfere with absorption of the investigational product (intestinal malabsorption syndrome, sprue, colitis, gastro-intestinal surgery, M. Whipple) 14.Dieases that carry a risk for hypercalcemia: Sarcoidosis, Tuberculosis, Lymphoma, primary hyperparathyroidism 15.Kidney stones 16.Creatinine clearance of less than 30 ml/min (severe kidney insufficiency) 17.Known hypersensitivity or allergy to dairy or milk products 18.Co-medications: Anticoagulants,use of steroids in any form, parathyroid hormone, corticosteroids, thiazide diuretic, Anticonvulsants, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali). 19.Use of any drug which might interfere with bone metabolism (biphosphonate, hormone replacement therapy, estrogen receptor modulators, calcitonin) within the precious 12 months 20.None-fat diets, or other extreme dietary habits 21.Subjects on a weight reduction program or a medically supervised diet 22.Signs of acute or severe illness: unintentional weight-loss, night sweats, treatment for cancer 23.Fracture in the last year or a fall in the last 3 months 24.Alcohol abuse:>=140g /week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower limb function: Knee extension strength assessment at 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure (systolic and diastolic). 2. Bone metabolism index. 3. Inflammatory markers index. 4. Japanese Osteoporosis Quality of Life Questionnaire7) 5. Blood 25(OH)D levels. | — |
Countries
Japan
Contacts
Public ContactYukihiko Ito
FANCL Corporation Research Institute
Outcome results
None listed