Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women

NCT01067508 | Completed Results

• 1 other identifier: 06-12-097-03
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Diseases, Metabolic

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Study Arms (2)

Fiji Water

EXPERIMENTAL

Participants are asked to consume one liter of this silicon-rich water daily for three months.

Other: Fiji Water

Aquafina Water

NO INTERVENTION

Participants are asked to drink one liter of this deionized water daily for three months.

Interventions

Fiji Water OTHER

Participants are asked to drink one liter of this silicon-rich water daily for three months.

Fiji Water

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Males
• Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2.
• Postmenopausal women with DEXA T scores ≤ -2.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Li Z, Karp H, Zerlin A, Lee TY, Carpenter C, Heber D. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study. Nutr J. 2010 Oct 14;9:44. doi: 10.1186/1475-2891-9-44.

  PMID: 20946656 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Zhaoping Li
• Organization: UCLA Center for Human Nutrition

zli@mednet.ucla.edu

310-206-1987

Study Officials

• David Heber, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 11, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)