Effects of Mineral Water Consumption on Serum Lipid Parameters

NCT ID: NCT00812617

Last Updated: 2009-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mineral water 1

Group Type EXPERIMENTAL

Mineral water (Hita, Oita, Japan)

Intervention Type DIETARY_SUPPLEMENT

Mineral water 2

Group Type EXPERIMENTAL

Mineral water (Aso-gun, Kumamoto, Japan)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Mineral water (Hita, Oita, Japan)

Intervention Type DIETARY_SUPPLEMENT

Mineral water (Aso-gun, Kumamoto, Japan)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hita Tenryosui Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role lead

Responsible Party

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Hiroshima University

Principal Investigators

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Fumiko Higashikawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hiroshima University

Locations

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Hiroshima University

Hiroshima, , Japan

Site Status

Countries

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Japan

Other Identifiers

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eki-77

Identifier Type: -

Identifier Source: org_study_id

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