Carotid Atherosclerosis, Carotid Intimal Medial Thickness 1
Conditions
Keywords
early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
one gelatine capsule containing starch per day, for 12 months
DIETARY_SUPPLEMENTLutein group
one gelatine capsule containing 20mg lutein per day, for 12 months
DIETARY_SUPPLEMENTCombination group
one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
DIETARY_SUPPLEMENTNormal lutein control group
subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 68 Years
Healthy volunteers
Yes
Inclusion criteria
* early atherosclerosis; * aged 45 to 68 years; * Han nationality
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Table 1 Study Specific Characteristic of Serum Carotenoids | at baseline | serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC) |
| Table 1 Study Specific Characteristic Part One | at baseline | The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated. |
| Table 1 Study Specific Characteristic of Age | at baseline | the mean and standard deviation of age was calculated in four groups |
| Table 1 Study Specific Characteristic of Body Mass Index (BMI) | at baseline | the mean and standard deviation of BMI in four groups was calculated |
| Table 1 Study Specific Characteristic of Blood Pressure (BP) | at baseline | systolic BP and diastolic BP in four groups was measure twice between 15minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake of Energy During the Study Periods | at baseline and 12 months | Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls. |
| Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods | at baseline and 12 months | 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. |
| Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months | 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). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo starch in hard shell gelatine capsules | 48 |
| Lutein Group 20mg lutein per day | 48 |
| Lutein and Lycopene Group lutein plus lycopene group | 48 |
| Normal Lutein Group subjects without early atherosclerosis | 48 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 4 | 1 |
Baseline characteristics
| Characteristic | Lutein Group | Lutein and Lycopene Group | Placebo | Normal Lutein Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 44 Participants | 45 Participants | 46 Participants | 179 Participants |
| Age Continuous | 57.4 years STANDARD_DEVIATION 4.4 | 57.3 years STANDARD_DEVIATION 4.9 | 57.4 years STANDARD_DEVIATION 5 | 53.8 years STANDARD_DEVIATION 5.8 | 56.5 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment China | 48 participants | 48 participants | 48 participants | 48 participants | 192 participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 30 Participants | 32 Participants | 116 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 18 Participants | 16 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 45 | 0 / 40 | 0 / 44 |
| serious Total, serious adverse events | 0 / 40 | 0 / 45 | 0 / 40 | 0 / 44 |
Outcome results
Primary
Table 1 Study Specific Characteristic of Age
the mean and standard deviation of age was calculated in four groups
Time frame: at baseline
Population: We conducted a per protocol analysis of all the subjects who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (P Group) | Table 1 Study Specific Characteristic of Age | 57.4 years | Standard Deviation 5 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Age | 57.4 years | Standard Deviation 4.4 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Age | 57.3 years | Standard Deviation 4.9 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Age | 53.8 years | Standard Deviation 5.8 |
Comparison: The null hypothesis was no group differencep-value: 0.992ANOVA
Primary
Table 1 Study Specific Characteristic of Blood Pressure (BP)
systolic BP and diastolic BP in four groups was measure twice between 15minutes
Time frame: at baseline
Population: We conducted a per protocol analysis of all the subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (P Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Systolic BP | 129.7 mm Hg | Standard Deviation 14.3 |
| Placebo (P Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Diastolic BP | 82.6 mm Hg | Standard Deviation 10.6 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Diastolic BP | 80.5 mm Hg | Standard Deviation 9.6 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Systolic BP | 125.5 mm Hg | Standard Deviation 16.4 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Systolic BP | 126.0 mm Hg | Standard Deviation 15.5 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Diastolic BP | 80.5 mm Hg | Standard Deviation 9.6 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Systolic BP | 117.7 mm Hg | Standard Deviation 11.9 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Blood Pressure (BP) | Diastolic BP | 77.2 mm Hg | Standard Deviation 8.1 |
Comparison: The null hypothesis was no group differencep-value: 0.402ANOVA
Primary
Table 1 Study Specific Characteristic of Body Mass Index (BMI)
the mean and standard deviation of BMI in four groups was calculated
Time frame: at baseline
Population: We conducted a per protocol analysis of all the subjects who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (P Group) | Table 1 Study Specific Characteristic of Body Mass Index (BMI) | 25.3 Kg/m^2 | Standard Deviation 2.6 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Body Mass Index (BMI) | 25.4 Kg/m^2 | Standard Deviation 3.2 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Body Mass Index (BMI) | 24.8 Kg/m^2 | Standard Deviation 3.2 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Body Mass Index (BMI) | 24.1 Kg/m^2 | Standard Deviation 2.7 |
Comparison: The null hypothesis was no group differencep-value: 0.672ANOVA
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)
Time frame: at baseline
Population: We conducted a per protocol analysis of all the subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (P Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lutein | 0.17 μg/ml | Standard Deviation 0.07 |
| Placebo (P Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Zeaxanthin | 0.034 μg/ml | Standard Deviation 0.022 |
| Placebo (P Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lycopene | 0.106 μg/ml | Standard Deviation 0.037 |
| Placebo (P Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | beta-carotene | 0.087 μg/ml | Standard Deviation 0.026 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lutein | 0.19 μg/ml | Standard Deviation 0.14 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lycopene | 0.092 μg/ml | Standard Deviation 0.043 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Zeaxanthin | 0.034 μg/ml | Standard Deviation 0.018 |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | beta-carotene | 0.069 μg/ml | Standard Deviation 0.026 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lutein | 0.20 μg/ml | Standard Deviation 0.11 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lycopene | 0.104 μg/ml | Standard Deviation 0.074 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | beta-carotene | 0.071 μg/ml | Standard Deviation 0.031 |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Zeaxanthin | 0.035 μg/ml | Standard Deviation 0.022 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lycopene | 0.098 μg/ml | Standard Deviation 0.038 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Lutein | 0.18 μg/ml | Standard Deviation 0.11 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | beta-carotene | 0.058 μg/ml | Standard Deviation 0.005 |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic of Serum Carotenoids | Zeaxanthin | 0.030 μg/ml | Standard Deviation 0.022 |
Comparison: The null hypothesis was no group differencep-value: 0.636ANOVA
Primary
Table 1 Study Specific Characteristic Part One
The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Time frame: at baseline
Population: We conducted a per protocol analysis of all the subjects who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (P Group) | Table 1 Study Specific Characteristic Part One | Diabetes history | 12.2 Percentage of Participants |
| Placebo (P Group) | Table 1 Study Specific Characteristic Part One | Race (Han people) | 100 Percentage of Participants |
| Placebo (P Group) | Table 1 Study Specific Characteristic Part One | Hyperlipemia history | 73.2 Percentage of Participants |
| Placebo (P Group) | Table 1 Study Specific Characteristic Part One | Hypertension history | 63.4 Percentage of Participants |
| Placebo (P Group) | Table 1 Study Specific Characteristic Part One | Female | 69.8 Percentage of Participants |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic Part One | Hypertension history | 57.4 Percentage of Participants |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic Part One | Diabetes history | 14.9 Percentage of Participants |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic Part One | Hyperlipemia history | 72.3 Percentage of Participants |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic Part One | Race (Han people) | 100 Percentage of Participants |
| Lutein Group (L Group) | Table 1 Study Specific Characteristic Part One | Female | 59.8 Percentage of Participants |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic Part One | Hypertension history | 56.8 Percentage of Participants |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic Part One | Female | 59.1 Percentage of Participants |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic Part One | Race (Han people) | 100 Percentage of Participants |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic Part One | Diabetes history | 13.6 Percentage of Participants |
| Lutein and Lycopene Group (LL Group) | Table 1 Study Specific Characteristic Part One | Hyperlipemia history | 75.0 Percentage of Participants |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic Part One | Diabetes history | 25.6 Percentage of Participants |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic Part One | Race (Han people) | 100 Percentage of Participants |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic Part One | Female | 72.7 Percentage of Participants |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic Part One | Hypertension history | 20.9 Percentage of Participants |
| Normal Lutein Control Group (NL Group) | Table 1 Study Specific Characteristic Part One | Hyperlipemia history | 65.1 Percentage of Participants |
Comparison: The null hypothesis was no group differencep-value: >0.05Chi-squared
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).
Time frame: 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.
Time frame: 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.
Time frame: at baseline and 12 months