HealthyNCT01167205
Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults
A study testing astaxanthin in people with Healthy and Overweight, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight, Obesity
- What is being tested?
- astaxanthin
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Mar 2011
- Phase
- Interventional
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with BMI over 25.0 kg/m2
- Non-smoker
Who cannot join
- Excessive alcohol consumption
- Pregnant or lactating women
- Dyslipidemia, hyperglycemia, or other chronic diseases.
- Subjects who were taking vitamin supplements
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Institute Seoul National University Hospital
Seoul, Seoul, 110-744
Wan Gyoon Shin, Ph D, Pharm D, +82 2 740 85556, wgshin@snu.ac.kr
About this study
The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.
- Conditions
- Healthy, Overweight, Obesity
- Being tested
- astaxanthin
- Keywords
- Healthy adults with BMI over 25.0 kg/m2
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
astaxanthinDietary supplement
astaxanthin 20mg for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the plasma MDA (malonaldehyde) level
MDA is a three chain aldehyde produced during the composition of a lipid hydroperoxide and is a well known indicator of lipid peroxidation.
The purpose of this stduy is to determine whether ASX supplementation lowers oxidative stress using MDA,a biomarker.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167205
- Sponsor's protocol ID
- C-1005-072-319
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT01167205
- Acronym / sponsor ID
- C-1005-072-319
- Conditions
- Healthy, Overweight, Obesity
- Keywords
- Healthy adults with BMI over 25.0 kg/m2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Aug 2010
- Primary completion
- Dec 2010
- Study completion
- Mar 2011
- First posted
- 22 Jul 2010 (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.
The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with BMI over 25.0 kg/m2
- Non-smoker
Key exclusion criteria (4 listed)
- Excessive alcohol consumption
- Pregnant or lactating women
- Dyslipidemia, hyperglycemia, or other chronic diseases.
- Subjects who were taking vitamin supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| astaxanthinastaxanthin 20mg for 12 weeks | Dietary supplement | – |
Primary outcome
Evaluation of the plasma MDA (malonaldehyde) level
Time frame: 12 weeks
MDA is a three chain aldehyde produced during the composition of a lipid hydroperoxide and is a well known indicator of lipid peroxidation. The purpose of this stduy is to determine whether ASX supplementation lowers oxidative stress using MDA,a biomarker.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing astaxanthin in people with Healthy and Overweight, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2010. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeo-kyu Youn, Doctor (+82 2 2072 3447, ykyoun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the plasma MDA (malonaldehyde) level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
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 22 Jul 2010.