- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812617
Effects of Mineral Water Consumption on Serum Lipid Parameters
October 5, 2009 updated by: Hiroshima University
Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial
The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hiroshima, Japan, 734-8551
- Hiroshima University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mineral water 1
|
|
Experimental: Mineral water 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting total cholesterol, LDL cholesterol, and triglyceride levels
Time Frame: Every 4 weeks (Overall 20 weeks)
|
Every 4 weeks (Overall 20 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting serum glucose and HbA1c levels
Time Frame: Every 4 weeks (Overall 20 weeks)
|
Every 4 weeks (Overall 20 weeks)
|
Serum uric acid level
Time Frame: Every 4 weeks (Overall 20 weeks)
|
Every 4 weeks (Overall 20 weeks)
|
Serum adiponectin and leptin levels
Time Frame: Week 0, Week 12
|
Week 0, Week 12
|
Urinary oxidative stress marker
Time Frame: Week 0, Week 12
|
Week 0, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 19, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Estimate)
October 6, 2009
Last Update Submitted That Met QC Criteria
October 5, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- eki-77
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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