Bone Mineral Density, Bone Turnover Marker, Calcium, Osteopenia
Conditions
Brief summary
This research was designed in accordance to the Method for Efficacy Assessment of Health Food for Bone Heath. Changes to bone density were measured to evaluate the effectiveness of amorphous calcium carbonate in maintaining bone health.
Detailed description
Bone comprises organic matter, predominantly protein, and inorganic matter including various mineral salts. Inappropriate nutrition profile can affect the balance of bone metabolism and cause bone loss. Of all nutrients, calcium is considered the most important for bone structure and metabolism. It is the most common deficit that affects bone health. Low dietary calcium intake can lead to negative calcium balance. Low blood calcium (\< 10mg/dL) induces the release of parathyroid hormone (PTH), which activates the conversion process of 25-(OH)-D3 to physiologically active 1,25-(OH)2-D3 in kidneys. PTH and 1,25-(OH)2-D3 act jointly to change the ionic valence of hydroxyapatite, converting orthophosphate to pyrophosphate. This causes hydroxyapatite to easily dissociate and release calcium ion in order to compensate the blood calcium level. This is called bone resorption. While this physiological mechanism maintains blood calcium homeostasis, it also causes bone loss that can develop into osteoporosis. Negative calcium balance is not only caused by lack of dietary calcium, hormonal abnormality or vitamin D deficit may also lead to negative calcium balance and the development of osteoporosis. This study aims to assess the effects of UIC Amorphous Calcium on osteoporosis with Bone Change Test and Calcium Bioavailability Test.
Interventions
DIETARY_SUPPLEMENTamorphous calcium carbonate/ Placebo
The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)
Sponsors
Taipei Medical University
Universal Integrated Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A Randomized, Double-Blind Trial
Intervention model description
A Placebo-Controlled Parallel-Group Trial
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).
Exclusion criteria
* respiratory insufficiency, * sleep apnea, * gastroesophageal reflux, * neurological or liver disease, * malignant tumor, alcohol abuse, * hysterectomy or hormonal therapy, * and depressive symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone density change | 6 months | monitoring bone mineral density change and bone turnover markers change |
Countries
Taiwan
Outcome results
None listed