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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014