Effects of Mineral Water Consumption on Serum Lipid Parameters

Healthy Clinical Trial

Official title:

Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812617
• Other study ID #: eki-77
• Status: Completed
• Phase: N/A
• First received: December 19, 2008
• Last updated: October 5, 2009
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mineral water (Hita, Oita, Japan)

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

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Hita Tenryosui Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting total cholesterol, LDL cholesterol, and triglyceride levels		Every 4 weeks (Overall 20 weeks)	No
Secondary	Fasting serum glucose and HbA1c levels		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum uric acid level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum adiponectin and leptin levels		Week 0, Week 12	No
Secondary	Urinary oxidative stress marker		Week 0, Week 12	No