Carotid AtherosclerosisPhase 2/3NCT01534533
Effects of Lutein Supplementation on Subclinical Atherosclerosis
A Phase 2/3 study testing Lutein group and Combination group in people with Carotid Atherosclerosis and Carotid Intimal Medial Thickness 1, run by Peking University at 1 site in China.
Trial summary
This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing. Read more about this study
- Who is it for?
- Ages 45 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis, Carotid Intimal Medial Thickness 1
- What is being tested?
- Lutein group and Combination group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- early atherosclerosis;
- aged 45 to 68 years;
- Han nationality
Who cannot join
- history of myocardial infarction,
- stroke,
- revascularization,
- coronary by-pass operation,
- local carotid IMT > 1300μm or supplemental vitamin and/or mineral use for ≥ 4 week before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Lutein Supplementation on Subclinical Atherosclerosis
This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
Read the detailed description
Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of which are the top two causes of death in industrialized countries including China. Lutein was found to be protective against atherosclerosis in some case control studies. However, the intervention on atherosclerosis have not been reported. In the present study, 192 subjects were randomly assigned to four groups treated with different amounts of lutein. The investigators observe the changes of serum lutein concentration by hyper-pressure liquid chromatography (HPLC), and compare the differences of common carotid IMT and arterial stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7 and 12 months of treatment by auto-analyzer.
- Being tested
- Placebo, Lutein group, Combination group, Normal lutein control group
- Keywords
- early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect
- Medical subject headings
- Carotid Artery Diseases, Carotid Intimal Medial Thickness 1, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
one gelatine capsule containing starch per day, for 12 months
Lutein groupDietary supplement
one gelatine capsule containing 20mg lutein per day, for 12 months
Combination groupDietary supplement
one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
Normal lutein control groupDietary supplement
subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day Receives: Dietary Supplement: Placebo |
| Lutein group | Experimental | early atherosclerosis cases, received 20mg lutein, once a day Receives: Dietary Supplement: Lutein group |
| Combination group | Experimental | early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day Receives: Dietary Supplement: Combination group |
| Normal lutein control group | Experimental | 20mg lutein for subjects free from atherosclerosis, once a day Receives: Dietary Supplement: Normal lutein control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Table 1 Study Specific Characteristic Part One
The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Measured: at baseline
Table 1 Study Specific Characteristic of Age
the mean and standard deviation of age was calculated in four groups
Measured: at baseline
Table 1 Study Specific Characteristic of Body Mass Index (BMI)
the mean and standard deviation of BMI in four groups was calculated
Measured: at baseline
Table 1 Study Specific Characteristic of Blood Pressure (BP)
systolic BP and diastolic BP in four groups was measure twice between 15minutes
Measured: at baseline
Table 1 Study Specific Characteristic of Serum Carotenoids
serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)
Measured: at baseline
Secondary outcomes (3)
Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months
Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).
Measured: at baseline and after 12 months
Dietary Intake of Energy During the Study Periods
Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
Measured: at baseline and 12 months
Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods
Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
Measured: at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Lin, Peking University
- Investigators
- Xiaoming Lin, M.M., Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534533
- Sponsor's protocol ID
- NNSFC-30972472
- Other IDs
- XLin
- Status last verified
- Jun 2013
- First submitted
- 13 Feb 2012
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zou Z, Xu X, Huang Y, Xiao X, Ma L, Sun T, Dong P, Wang X, Lin X. High serum level of lutein may be protective against early atherosclerosis: the Beijing atherosclerosis study. Atherosclerosis. 2011 Dec;219(2):789-93. doi: 10.1016/j.atherosclerosis.2011.08.006. Epub 2011 Aug 10.
PubMed 21872250
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lutein Supplementation on Subclinical Atherosclerosis
- ClinicalTrials.gov ID
- NCT01534533
- Acronym / sponsor ID
- NNSFC-30972472
- Keywords
- early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Posted 15 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
Detailed description
Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of which are the top two causes of death in industrialized countries including China. Lutein was found to be protective against atherosclerosis in some case control studies. However, the intervention on atherosclerosis have not been reported. In the present study, 192 subjects were randomly assigned to four groups treated with different amounts of lutein. The investigators observe the changes of serum lutein concentration by hyper-pressure liquid chromatography (HPLC), and compare the differences of common carotid IMT and arterial stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7 and 12 months of treatment by auto-analyzer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboearly atherosclerosis cases, received starch in hard shell gelatine capsules, once a day |
| Lutein group | Experimental | Dietary Supplement: Lutein groupearly atherosclerosis cases, received 20mg lutein, once a day |
| Combination group | Experimental | Dietary Supplement: Combination groupearly atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day |
| Normal lutein control group | Experimental | Dietary Supplement: Normal lutein control group20mg lutein for subjects free from atherosclerosis, once a day |
Who may qualify
- Ages
- 45 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- early atherosclerosis;
- aged 45 to 68 years;
- Han nationality
Key exclusion criteria (5 listed)
- history of myocardial infarction,
- stroke,
- revascularization,
- coronary by-pass operation,
- local carotid IMT > 1300μm or supplemental vitamin and/or mineral use for ≥ 4 week before the start of the study
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 |
|---|---|---|
| Placeboone gelatine capsule containing starch per day, for 12 months | Dietary supplement | Placebo |
| Lutein groupone gelatine capsule containing 20mg lutein per day, for 12 months | Dietary supplement | Lutein group |
| Combination groupone gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months | Dietary supplement | Combination group |
| Normal lutein control groupsubjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months | Dietary supplement | Normal lutein control group |
Primary outcome
Table 1 Study Specific Characteristic Part One
Time frame: at baseline
The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Table 1 Study Specific Characteristic of Age
Time frame: at baseline
the mean and standard deviation of age was calculated in four groups
Table 1 Study Specific Characteristic of Body Mass Index (BMI)
Time frame: at baseline
the mean and standard deviation of BMI in four groups was calculated
Table 1 Study Specific Characteristic of Blood Pressure (BP)
Time frame: at baseline
systolic BP and diastolic BP in four groups was measure twice between 15minutes
Table 1 Study Specific Characteristic of Serum Carotenoids
Time frame: at baseline
serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)
3 secondary outcomes
Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months
Time frame: at baseline and after 12 months
Dietary Intake of Energy During the Study Periods
Time frame: at baseline and 12 months
Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods
Time frame: at baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21872250Zou Z, Xu X, Huang Y, Xiao X, Ma L, Sun T, Dong P, Wang X, Lin X. High serum level of lutein may be protective against early atherosclerosis: the Beijing atherosclerosis study. Atherosclerosis. 2011 Dec;219(2):789-93. doi: 10.1016/j.atherosclerosis.2011.08.006. Epub 2011 Aug 10.
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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.
Xiaoming Lin, M.M. principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lutein group and Combination group in people with Carotid Atherosclerosis and Carotid Intimal Medial Thickness 1, run by Peking University at 1 site in China.
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 3 inclusion and 5 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 22 Jul 2013. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Table 1 Study Specific Characteristic Part One (time frame: at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534533, which also lists 1 linked publication.
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 2013.