Text Size

Effects of Mineral Water Consumption on Serum Lipid Parameters

This study has been completed.
Sponsor:
Collaborator:
Hita Tenryosui Co., Ltd.
Information provided by:
Hiroshima University
ClinicalTrials.gov Identifier:
NCT00812617
First received: December 19, 2008
Last updated: October 5, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: Mineral water (Hita, Oita, Japan)
Dietary Supplement: Mineral water (Aso-gun, Kumamoto, Japan)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Fasting total cholesterol, LDL cholesterol, and triglyceride levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting serum glucose and HbA1c levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Serum uric acid level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Serum adiponectin and leptin levels [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Urinary oxidative stress marker [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2008
Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: Mineral water 1 Dietary Supplement: Mineral water (Hita, Oita, Japan)
Experimental: Mineral water 2 Dietary Supplement: Mineral water (Aso-gun, Kumamoto, Japan)

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812617

Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Hita Tenryosui Co., Ltd.
Investigators
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
  More Information

No publications provided

Responsible Party: Fumiko higashikawa, Hiroshima University
ClinicalTrials.gov Identifier: NCT00812617     History of Changes
Other Study ID Numbers: eki-77
Study First Received: December 19, 2008
Last Updated: October 5, 2009
Health Authority: Japan: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013