Effects of Lutein Supplementation on Subclinical Atherosclerosis

• Sponsor: Peking University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01534533
• Collaborator: (none)
• Enrollment: 192
• Location: 1
• Arms: 4
• Duration (Months): 24
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis; Carotid Intimal Medial Thickness 1	Dietary Supplement: Placebo; Dietary Supplement: Lutein group; Dietary Supplement: Combination group; Dietary Supplement: Normal lutein control group	Phase 2/Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effects of Lutein Supplementation on Subclinical Atherosclerosis
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day	Dietary Supplement: Placebo; one gelatine capsule containing starch per day, for 12 months
Experimental: Lutein group early atherosclerosis cases, received 20mg lutein, once a day	Dietary Supplement: Lutein group; one gelatine capsule containing 20mg lutein per day, for 12 months
Experimental: Combination group early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day	Dietary Supplement: Combination group; one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
Experimental: Normal lutein control group 20mg lutein for subjects free from atherosclerosis, once a day	Dietary Supplement: Normal lutein control group; subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months

Outcome Measures

Primary Outcome Measures

1. Table 1 Study Specific Characteristic Part One [at baseline]

   The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.

2. Table 1 Study Specific Characteristic of Age [at baseline]

   the mean and standard deviation of age was calculated in four groups

3. Table 1 Study Specific Characteristic of Body Mass Index (BMI) [at baseline]

   the mean and standard deviation of BMI in four groups was calculated

4. Table 1 Study Specific Characteristic of Blood Pressure (BP) [at baseline]

   systolic BP and diastolic BP in four groups was measure twice between 15minutes

5. 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)

Secondary Outcome Measures

1. 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).

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haidian District	Beijing		China	100191

Sponsors and Collaborators

• Peking University

Investigators

• Principal Investigator: Xiaoming Lin, M.M., Peking University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Xiaoming Lin, Professor, Peking University
• ClinicalTrials.gov Identifier: NCT01534533
• Other Study ID Numbers: NNSFC-30972472; XLin
• First Posted: Feb 16, 2012
• Last Update Posted: Jul 22, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Xiaoming Lin, Professor, Peking University: early atherosclerosis; serum lutein; serum lycopene; intima-media thickness; arterial stiffness; combined effect
• Additional relevant MeSH terms: Carotid Artery Diseases; Atherosclerosis

Study Results

Participant Flow

Arm/Group Title	Placebo	Lutein Group	Lutein and Lycopene Group	Normal Lutein Group
Arm/Group Description	starch in hard shell gelatine capsules	20mg lutein per day	lutein plus lycopene group	subjects without early atherosclerosis
Period Title: Overall Study
STARTED	48	48	48	48
COMPLETED	40	45	40	44
NOT COMPLETED	8	3	8	4

Baseline Characteristics

Arm/Group Title	Placebo	Lutein Group	Lutein and Lycopene Group	Normal Lutein Group	Total
Arm/Group Description	starch in hard shell gelatine capsules	20mg lutein per day	lutein plus lycopene group	subjects without early atherosclerosis	Total of all reporting groups
Overall Participants	48	48	48	48	192
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	45 93.8%	44 91.7%	44 91.7%	46 95.8%	179 93.2%
>=65 years	3 6.3%	4 8.3%	4 8.3%	2 4.2%	13 6.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.4 (5.0)	57.4 (4.4)	57.3 (4.9)	53.8 (5.8)	56.5 (5.2)
Sex: Female, Male (Count of Participants)
Female	30 62.5%	28 58.3%	26 54.2%	32 66.7%	116 60.4%
Male	18 37.5%	20 41.7%	22 45.8%	16 33.3%	76 39.6%
Region of Enrollment (participants) [Number]
China	48 100%	48 100%	48 100%	48 100%	192 100%

Outcome Measures

1. Primary Outcome

Title	Table 1 Study Specific Characteristic Part One
Description	The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

We conducted a per protocol analysis of all the subjects who completed the study.

Arm/Group Title	Placebo (P Group)	Lutein Group (L Group)	Lutein and Lycopene Group (LL Group)	Normal Lutein Control Group (NL Group)
Arm/Group Description	starch in hard shell gelatine capsules	early atherosclerosis case received 20mg lutein	received 20mg lutein and 20mg lycopene	subjects free from atherosclerosis received 20mg lutein
Measure Participants	40	45	40	44
Female	69.8 145.4%	59.8 124.6%	59.1 123.1%	72.7 151.5%
Race (Han people)	100 208.3%	100 208.3%	100 208.3%	100 208.3%
Hypertension history	63.4 132.1%	57.4 119.6%	56.8 118.3%	20.9 43.5%
Diabetes history	12.2 25.4%	14.9 31%	13.6 28.3%	25.6 53.3%
Hyperlipemia history	73.2 152.5%	72.3 150.6%	75.0 156.3%	65.1 135.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (P Group), Lutein Group (L Group), Lutein and Lycopene Group (LL Group)
	Comments	The null hypothesis was "no group difference"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The a priori threshold for statistical significance was 0.05 (two sides)
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Table 1 Study Specific Characteristic of Age
Description	the mean and standard deviation of age was calculated in four groups
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

We conducted a per protocol analysis of all the subjects who completed the study.

Arm/Group Title	Placebo (P Group)	Lutein Group (L Group)	Combination Group (LL Group)	Normal Lutein Control Group (NL Group)
Arm/Group Description	starch in hard shell gelatine capsules	early atherosclerosis case received 20mg lutein	received 20mg lutein and 20mg lycopene	subjects free from atherosclerosis received 20mg lutein
Measure Participants	40	45	40	44
Mean (Standard Deviation) [years]	57.4 (5.0)	57.4 (4.4)	57.3 (4.9)	53.8 (5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (P Group), Lutein Group (L Group), Lutein and Lycopene Group (LL Group)
	Comments	The null hypothesis was "no group difference"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.992
	Comments	The a priori threshold for statistical significance was 0.05 (two sides)
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Table 1 Study Specific Characteristic of Body Mass Index (BMI)
Description	the mean and standard deviation of BMI in four groups was calculated
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

We conducted a per protocol analysis of all the subjects who completed the study.

Arm/Group Title	Placebo (P Group)	Lutein Group (L Group)	Combination Group (LL Group)	Normal Lutein Control Group (NL Group)
Arm/Group Description	starch in hard shell gelatine capsules	early atherosclerosis case received 20mg lutein	received 20mg lutein and 20mg lycopene	subjects free from atherosclerosis received 20mg lutein
Measure Participants	40	45	40	44
Mean (Standard Deviation) [Kg/m^2]	25.3 (2.6)	25.4 (3.2)	24.8 (3.2)	24.1 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (P Group), Lutein Group (L Group), Lutein and Lycopene Group (LL Group)
	Comments	The null hypothesis was "no group difference"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.672
	Comments	The a priori threshold for statistical significance was 0.05 (two sides)
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Table 1 Study Specific Characteristic of Blood Pressure (BP)
Description	systolic BP and diastolic BP in four groups was measure twice between 15minutes
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

We conducted a per protocol analysis of all the subjects who completed the study.

Arm/Group Title	Placebo (P Group)	Lutein Group (L Group)	Lutein and Lycopene Group (LL Group)	Normal Lutein Control Group (NL Group)
Arm/Group Description	starch in hard shell gelatine capsules	early atherosclerosis case received 20mg lutein	received 20mg lutein and 20mg lycopene	subjects free from atherosclerosis received 20mg lutein
Measure Participants	43	47	44	44
Systolic BP	129.7 (14.3)	125.5 (16.4)	126.0 (15.5)	117.7 (11.9)
Diastolic BP	82.6 (10.6)	80.5 (9.6)	80.5 (9.6)	77.2 (8.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (P Group), Lutein Group (L Group), Lutein and Lycopene Group (LL Group)
	Comments	The null hypothesis was "no group difference"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.402
	Comments	The a priori threshold for statistical significance was 0.05 (two sides)
	Method	ANOVA
	Comments

5. Primary Outcome

Title	Table 1 Study Specific Characteristic of Serum Carotenoids
Description	serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)
Time Frame	at baseline

Outcome Measure Data

Analysis Population Description

We conducted a per protocol analysis of all the subjects who completed the study.

Arm/Group Title	Placebo (P Group)	Lutein Group (L Group)	Combination Group (LL Group)	Normal Lutein Control Group (NL Group)
Arm/Group Description	starch in hard shell gelatine capsules	early atherosclerosis case received 20mg lutein	early atherosclerosis cases received 20mg lutein and 20mg lycopene	subjects free from atherosclerosis received 20mg lutein
Measure Participants	40	45	40	44
Lutein	0.17 (0.07)	0.19 (0.14)	0.20 (0.11)	0.18 (0.11)
Zeaxanthin	0.034 (0.022)	0.034 (0.018)	0.035 (0.022)	0.030 (0.022)
beta-carotene	0.087 (0.026)	0.069 (0.026)	0.071 (0.031)	0.058 (0.005)
Lycopene	0.106 (0.037)	0.092 (0.043)	0.104 (0.074)	0.098 (0.038)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (P Group), Lutein Group (L Group), Lutein and Lycopene Group (LL Group)
	Comments	The null hypothesis was "no group difference"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.636
	Comments	The a priori threshold for statistical significance was 0.05 (two sides)
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Dietary Intake of Energy During the Study Periods
Description	Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
Time Frame	at baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	adverse event data were collected in 12months
Arm/Group Title	Placebo		Lutein Group		Combination Group		Normal Lutein Control Group
Arm/Group Description	early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day		early atherosclerosis cases, received 20mg lutein, once a day		early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day		20mg lutein for subjects free from atherosclerosis, once a day
All Cause Mortality
	Placebo		Lutein Group		Combination Group		Normal Lutein Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Lutein Group		Combination Group		Normal Lutein Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/45 (0%)		0/40 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Lutein Group		Combination Group		Normal Lutein Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/45 (0%)		0/40 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.