Metabolic SyndromeNCT01412476
Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Metabolic syndrome
- Healthy individuals with normal blood biochemical values.
Who cannot join
- Age < 18y
- Antioxidant vitamins supplements use
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | Subjects with metabolic syndrome | |
| control group | Healthy individuals |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Ping-Ting Lin, Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412476
- Sponsor's protocol ID
- CS09155
- Status last verified
- Mar 2012
- First submitted
- 8 Aug 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01412476
- Acronym / sponsor ID
- CS09155
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –Subjects with metabolic syndrome |
| control group | – | –Healthy individuals |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Metabolic syndrome
- Healthy individuals with normal blood biochemical values.
Key exclusion criteria (3 listed)
- Age < 18y
- Antioxidant vitamins supplements use
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Ting Lin, Ph.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.