- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412476
Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
March 23, 2012 updated by: Chung Shan Medical University
Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease.
However, the relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention of the risk of MS are still inconsistent.
The purposes of this study are going to investigate the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels, the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6 and adiponectin).
The investigators will recruit MS patients (case group, n = 100) and age-gender matched healthy subjects from previous study(n = 105) as a control group .
The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007).Hopefully, the results of this study could provide the information to what has been know in MS subjects.
The investigators expect coenzyme Q10 or antioxidant vitamins could be a preventive supplement to reduce the risk of MS.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
72
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
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Taichung, Taiwan
- Ping-Ting Lin
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The investigators recruited MS patients (case group, n = 100).
The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007).
The health subject were recrited from previous study (n = 105).
Description
Inclusion Criteria:
- Metabolic syndrome
- Healthy individuals with normal blood biochemical values.
Exclusion Criteria:
- Age < 18y
- Antioxidant vitamins supplements use
- Pregnant women
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
Cohorts and Interventions
Group / Cohort |
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case group
Subjects with metabolic syndrome
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control group
Healthy individuals
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ping-Ting Lin, Ph.D., Chung Shan Medical University
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
August 1, 2010
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 8, 2011
First Submitted That Met QC Criteria
August 8, 2011
First Posted (Estimate)
August 9, 2011
Study Record Updates
Last Update Posted (Estimate)
March 26, 2012
Last Update Submitted That Met QC Criteria
March 23, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS09155
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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