Effects of Mineral Water Consumption on Serum Lipid Parameters

Hiroshima University90 enrolled

Overview

The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Mineral water (Hita, Oita, Japan)DIETARY_SUPPLEMENT

Mineral water (Aso-gun, Kumamoto, Japan)DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hiroshima University

Hiroshima, Japan

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

Time frame: Every 4 weeks (Overall 20 weeks)

Serum uric acid level

Time frame: Every 4 weeks (Overall 20 weeks)

Serum adiponectin and leptin levels

Time frame: Week 0, Week 12

Urinary oxidative stress marker

Time frame: Week 0, Week 12

Data from ClinicalTrials.gov

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