Healthy
Conditions
Brief summary
The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.
Interventions
DIETARY_SUPPLEMENTMineral water (Hita, Oita, Japan)
DIETARY_SUPPLEMENTMineral water (Aso-gun, Kumamoto, Japan)
Sponsors
Hita Tenryosui Co., Ltd.
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting total cholesterol, LDL cholesterol, and triglyceride levels | Every 4 weeks (Overall 20 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed