NCT00812617
Completed
Not Applicable
Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial
ConditionsHealthy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hiroshima University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Fasting total cholesterol, LDL cholesterol, and triglyceride levels
Overview
Brief Summary
The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy as based on medical history and physical examination
- •Fasting serum LDL cholesterol \> 100 and/or fasting serum triglyceride \> 100
- •Willing to drink mineral water for 12 weeks
- •Willing not to serve as blood donor during the study
- •Informed consent signed
Exclusion Criteria
- •Female subjects who are pregnant or nursing a child
- •Participation in any clinical trial up to 90 days before Day 01 of this study
- •Renal or hepatic dysfunction
- •Heart disease
Outcomes
Primary Outcomes
Fasting total cholesterol, LDL cholesterol, and triglyceride levels
Time Frame: Every 4 weeks (Overall 20 weeks)
Secondary Outcomes
- Fasting serum glucose and HbA1c levels(Every 4 weeks (Overall 20 weeks))
- Serum uric acid level(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin and leptin levels(Week 0, Week 12)
- Urinary oxidative stress marker(Week 0, Week 12)
Investigators
Study Sites (1)
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