Bone Diseases, Metabolic
Conditions
Brief summary
The aim of this research study is to determine by laboratory analyses the effects of drinking silicon-rich water on bone health. This will be determined from blood and urine samples from subjects who will be asked to drink 1 liter per day of either silicon-rich water or water without silicon for 12 weeks.
Detailed description
Naturally occurring silicon as aqueous silicic acids at a level of 85 mg/liter which is well within safe intake limits occurs in water obtained from artesian wells in Fiji (Fiji Water, Inc.). Other drinking waters (e.g. Aquafina, Crystal Geyser, etc.) have all trace minerals including silicon removed by reverse osmosis. Silicon may be a necessary mineral for bone health. Therefore, this study aims to demonstrate the potential beneficial effects of short-term intake of silicon-rich water (85 mg/day of silicon in the diet from 1 liter of Fiji Water) compared to deionized water (with no silicon) over 12 weeks in normal postmenopausal women. The women to be studied will be stratified by bone density (based on T score by DEXA) and have analyses of biomarkers of bone metabolism to achieve the following specific aims: 1. To conduct a prospective randomized controlled trial in two mixed groups of 15 normal postmenopausal women and osteopenic pre- and peri-menopausal women receiving either 1 liter per day of FIJI water (A) or 1 liter per day of purified drinking water with no minerals (B). During screening we will ask prospective participants about their menopausal status (where post-menopausal means having no menstrual period for one year), block on their menopausal status, and randomize to either Treatment A or Treatment B. There will be 7-8 post-menopausal women and 7-8 pre- or peri-menopausal women in each group. 2. To determine silicon absorption by measuring urinary silicon excretion 3. To determine bone resorption and turn over markers by measuring urinary N-Telopeptide, serum bone alkaline phosphatase, osteocalcin, procollagen Type I Intact N-Terminal Propeptide, 25 hydroxyvitamin D, parathyroid hormone (PTH) and calcium.
Interventions
OTHERFiji Water
Participants are asked to drink one liter of this silicon-rich water daily for three months.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) \< 30 * Postmenopausal women with no evidence of osteoporosis by dual energy X-ray absorptiometry (DEXA) scan (T ≥ -2 in the total hip and lumbar spine). * Pre- or peri-menopausal women with osteopenia but no evidence of osteoporosis by DEXA scan (-1.5 ≤ T ≤ -2 in the total hip and lumbar spine) * No estrogens or corticosteroids * No prior history of bisphosphonate medication * Otherwise in good health with no significant illnesses which could affect bone metabolism such as hypercortisolism, untreated hypothyroidism, treatment with statins or other drugs affecting bone metabolism other than calcium and vitamin D3. * No change in exercise regimen or calcium intake in the past 3 months. * Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Exclusion criteria
* Males * Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2. * Postmenopausal women with DEXA T scores ≤ -2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Silicon Absorption at 12 Weeks | 12 Weeks | Change from baseline in silicon absorption in response to silicon-rich water (Fiji) supplementation for 12 weeks was determined by measuring urinary solicon concentration (mg/mg) normalized to creatinine. |
Countries
United States
Participant flow
Recruitment details
Subjects will be recruited by posting flyers around the UCLA campus community. Initial eligibility will be determined by a telephone conversation in which the study procedures and inclusion/exclusion criteria are reviewed.
Participants by arm
| Arm | Count |
|---|---|
| Fiji Water Participants are asked to consume 1 liter of this silicon-rich water (Fiji) daily for 12 weeks. | 10 |
| Aquafina Water Participants are asked to drink 1 liter of this deionized water daily for 12 weeks. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Fiji Water | Aquafina Water | Total |
|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 6.5 | 54.4 years STANDARD_DEVIATION 3.9 | 53.75 years STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 10 Participants | 9 Participants | 19 Participants |
| Sex/Gender, Customized Female | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 1 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Change From Baseline in Silicon Absorption at 12 Weeks
Change from baseline in silicon absorption in response to silicon-rich water (Fiji) supplementation for 12 weeks was determined by measuring urinary solicon concentration (mg/mg) normalized to creatinine.
Time frame: 12 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aquafina Water | Change From Baseline in Silicon Absorption at 12 Weeks | baseline silicon | 0.010 mg/mg creatinine | Standard Deviation 0.004 |
| Aquafina Water | Change From Baseline in Silicon Absorption at 12 Weeks | 12 week silicon | 0.009 mg/mg creatinine | Standard Deviation 0.006 |
| Fiji Water | Change From Baseline in Silicon Absorption at 12 Weeks | baseline silicon | 0.016 mg/mg creatinine | Standard Deviation 0.01 |
| Fiji Water | Change From Baseline in Silicon Absorption at 12 Weeks | 12 week silicon | 0.037 mg/mg creatinine | Standard Deviation 0.014 |
Comparison: Comparison was made to 12 weeks minus baseline change in Fiji water groupp-value: 0.003t-test, 2 sided
Comparison: Comparison was made to the 12 week minus baseline change in Aquafina (control) groupp-value: 0.68t-test, 2 sided