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| ID | Type | Description | Link |
|---|---|---|---|
| XLin | Registry Identifier | XLin |
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This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day |
|
| Lutein group | Experimental | early atherosclerosis cases, received 20mg lutein, once a day |
|
| Combination group | Experimental | early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day |
|
| Normal lutein control group | Experimental | 20mg lutein for subjects free from atherosclerosis, once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | one gelatine capsule containing starch per day, for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Table 1 Study Specific Characteristic Part One | The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated. | at baseline |
| Table 1 Study Specific Characteristic of Age | the mean and standard deviation of age was calculated in four groups | at baseline |
| Table 1 Study Specific Characteristic of Body Mass Index (BMI) | the mean and standard deviation of BMI in four groups was calculated | at baseline |
| Table 1 Study Specific Characteristic of Blood Pressure (BP) | systolic BP and diastolic BP in four groups was measure twice between 15minutes | 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) | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at baseline and after 12 months |
| Dietary Intake of Energy During the Study Periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Lin, M.M. | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haidian District | Beijing | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21872250 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | starch in hard shell gelatine capsules |
| FG001 | Lutein Group | 20mg lutein per day |
| FG002 | Lutein and Lycopene Group | lutein plus lycopene group |
| FG003 | Normal Lutein Group | subjects without early atherosclerosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | starch in hard shell gelatine capsules |
| BG001 | Lutein Group | 20mg lutein per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Table 1 Study Specific Characteristic Part One | The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated. | We conducted a per protocol analysis of all the subjects who completed the study. | Posted | Number | Percentage of Participants | at baseline |
|
adverse event data were collected in 12months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zhiyong Zou | Peking University | +8610-13581525193 | harveyzou2002@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| C563733 | Carotid Intimal Medial Thickness 1 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Lutein group |
| Dietary Supplement |
one gelatine capsule containing 20mg lutein per day, for 12 months |
|
| Combination group | Dietary Supplement | one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months |
|
| Normal lutein control group | Dietary Supplement | subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months |
|
Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls. |
| 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. | at baseline and 12 months |
| Withdrawal by Subject |
|
| BG002 |
| Lutein and Lycopene Group |
lutein plus lycopene group |
| BG003 | Normal Lutein Group | subjects without early atherosclerosis |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
received 20mg lutein and 20mg lycopene |
| OG003 | Normal Lutein Control Group (NL Group) | subjects free from atherosclerosis received 20mg lutein |
|
|
|
| Primary | Table 1 Study Specific Characteristic of Age | the mean and standard deviation of age was calculated in four groups | We conducted a per protocol analysis of all the subjects who completed the study. | Posted | Mean | Standard Deviation | years | at baseline |
|
|
|
|
| Primary | Table 1 Study Specific Characteristic of Body Mass Index (BMI) | the mean and standard deviation of BMI in four groups was calculated | We conducted a per protocol analysis of all the subjects who completed the study. | Posted | Mean | Standard Deviation | Kg/m^2 | at baseline |
|
|
|
|
| Primary | Table 1 Study Specific Characteristic of Blood Pressure (BP) | systolic BP and diastolic BP in four groups was measure twice between 15minutes | We conducted a per protocol analysis of all the subjects who completed the study. | Posted | Mean | Standard Deviation | mm Hg | at baseline |
|
|
|
|
| Primary | 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) | We conducted a per protocol analysis of all the subjects who completed the study. | Posted | Mean | Standard Deviation | μg/ml | at baseline |
|
|
|
|
| Secondary | 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). | Not Posted | Dec 3333 | at baseline and after 12 months |
| Secondary | Dietary Intake of Energy During the Study Periods | Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls. | Not Posted | Dec 3333 | at baseline and 12 months |
| Secondary | 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. | Not Posted | Dec 3333 | at baseline and 12 months |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lutein Group | early atherosclerosis cases, received 20mg lutein, once a day | 0 | 45 | 0 | 45 |
| EG002 | Combination Group | early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day | 0 | 40 | 0 | 40 |
| EG003 | Normal Lutein Control Group | 20mg lutein for subjects free from atherosclerosis, once a day | 0 | 44 | 0 | 44 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Diastolic BP |
|
| Zeaxanthin |
|
| beta-carotene |
|
| Lycopene |
|