Trial Outcomes & Findings for Effects of Lutein Supplementation on Subclinical Atherosclerosis (NCT NCT01534533)

NCT ID: NCT01534533

Last Updated: 2013-07-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 192 participants
• Primary outcome timeframe: at baseline
• Results posted on: 2013-07-22

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Placebo starch in hard shell gelatine capsules	Lutein Group 20mg lutein per day	Lutein and Lycopene Group lutein plus lycopene group	Normal Lutein Group subjects without early atherosclerosis
Overall Study Lost to Follow-up	3	0	4	3
Overall Study Withdrawal by Subject	5	3	4	1

Baseline Characteristics

Effects of Lutein Supplementation on Subclinical Atherosclerosis

Baseline characteristics by cohort

Measure	Placebo n=48 Participants starch in hard shell gelatine capsules	Lutein Group n=48 Participants 20mg lutein per day	Lutein and Lycopene Group n=48 Participants lutein plus lycopene group	Normal Lutein Group n=48 Participants subjects without early atherosclerosis	Total n=192 Participants Total of all reporting groups
Region of Enrollment China	48 participants n=93 Participants	48 participants n=4 Participants	48 participants n=27 Participants	48 participants n=483 Participants	192 participants n=36 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	44 Participants n=4 Participants	44 Participants n=27 Participants	46 Participants n=483 Participants	179 Participants n=36 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	13 Participants n=36 Participants
Age Continuous	57.4 years STANDARD_DEVIATION 5.0 • n=93 Participants	57.4 years STANDARD_DEVIATION 4.4 • n=4 Participants	57.3 years STANDARD_DEVIATION 4.9 • n=27 Participants	53.8 years STANDARD_DEVIATION 5.8 • n=483 Participants	56.5 years STANDARD_DEVIATION 5.2 • n=36 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	28 Participants n=4 Participants	26 Participants n=27 Participants	32 Participants n=483 Participants	116 Participants n=36 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	20 Participants n=4 Participants	22 Participants n=27 Participants	16 Participants n=483 Participants	76 Participants n=36 Participants

PRIMARY outcome

Timeframe: at baseline

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

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

Outcome measures

Measure	Placebo (P Group) n=40 Participants starch in hard shell gelatine capsules	Lutein Group (L Group) n=45 Participants early atherosclerosis case received 20mg lutein	Lutein and Lycopene Group (LL Group) n=40 Participants received 20mg lutein and 20mg lycopene	Normal Lutein Control Group (NL Group) n=44 Participants subjects free from atherosclerosis received 20mg lutein
Table 1 Study Specific Characteristic Part One Hypertension history	63.4 Percentage of Participants	57.4 Percentage of Participants	56.8 Percentage of Participants	20.9 Percentage of Participants
Table 1 Study Specific Characteristic Part One Female	69.8 Percentage of Participants	59.8 Percentage of Participants	59.1 Percentage of Participants	72.7 Percentage of Participants
Table 1 Study Specific Characteristic Part One Race (Han people)	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Table 1 Study Specific Characteristic Part One Diabetes history	12.2 Percentage of Participants	14.9 Percentage of Participants	13.6 Percentage of Participants	25.6 Percentage of Participants
Table 1 Study Specific Characteristic Part One Hyperlipemia history	73.2 Percentage of Participants	72.3 Percentage of Participants	75.0 Percentage of Participants	65.1 Percentage of Participants

PRIMARY outcome

Timeframe: at baseline

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

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

Outcome measures

Measure	Placebo (P Group) n=40 Participants starch in hard shell gelatine capsules	Lutein Group (L Group) n=45 Participants early atherosclerosis case received 20mg lutein	Lutein and Lycopene Group (LL Group) n=40 Participants received 20mg lutein and 20mg lycopene	Normal Lutein Control Group (NL Group) n=44 Participants subjects free from atherosclerosis received 20mg lutein
Table 1 Study Specific Characteristic of Age	57.4 years Standard Deviation 5.0	57.4 years Standard Deviation 4.4	57.3 years Standard Deviation 4.9	53.8 years Standard Deviation 5.8

PRIMARY outcome

Timeframe: at baseline

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

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

Outcome measures

Measure	Placebo (P Group) n=40 Participants starch in hard shell gelatine capsules	Lutein Group (L Group) n=45 Participants early atherosclerosis case received 20mg lutein	Lutein and Lycopene Group (LL Group) n=40 Participants received 20mg lutein and 20mg lycopene	Normal Lutein Control Group (NL Group) n=44 Participants subjects free from atherosclerosis received 20mg lutein
Table 1 Study Specific Characteristic of Body Mass Index (BMI)	25.3 Kg/m^2 Standard Deviation 2.6	25.4 Kg/m^2 Standard Deviation 3.2	24.8 Kg/m^2 Standard Deviation 3.2	24.1 Kg/m^2 Standard Deviation 2.7

PRIMARY outcome

Timeframe: at baseline

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

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

Outcome measures

Measure	Placebo (P Group) n=43 Participants starch in hard shell gelatine capsules	Lutein Group (L Group) n=47 Participants early atherosclerosis case received 20mg lutein	Lutein and Lycopene Group (LL Group) n=44 Participants received 20mg lutein and 20mg lycopene	Normal Lutein Control Group (NL Group) n=44 Participants subjects free from atherosclerosis received 20mg lutein
Table 1 Study Specific Characteristic of Blood Pressure (BP) Diastolic BP	82.6 mm Hg Standard Deviation 10.6	80.5 mm Hg Standard Deviation 9.6	80.5 mm Hg Standard Deviation 9.6	77.2 mm Hg Standard Deviation 8.1
Table 1 Study Specific Characteristic of Blood Pressure (BP) Systolic BP	129.7 mm Hg Standard Deviation 14.3	125.5 mm Hg Standard Deviation 16.4	126.0 mm Hg Standard Deviation 15.5	117.7 mm Hg Standard Deviation 11.9

PRIMARY outcome

Timeframe: at baseline

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

serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)

Outcome measures

Measure	Placebo (P Group) n=40 Participants starch in hard shell gelatine capsules	Lutein Group (L Group) n=45 Participants early atherosclerosis case received 20mg lutein	Lutein and Lycopene Group (LL Group) n=40 Participants received 20mg lutein and 20mg lycopene	Normal Lutein Control Group (NL Group) n=44 Participants subjects free from atherosclerosis received 20mg lutein
Table 1 Study Specific Characteristic of Serum Carotenoids Lutein	0.17 μg/ml Standard Deviation 0.07	0.19 μg/ml Standard Deviation 0.14	0.20 μg/ml Standard Deviation 0.11	0.18 μg/ml Standard Deviation 0.11
Table 1 Study Specific Characteristic of Serum Carotenoids Zeaxanthin	0.034 μg/ml Standard Deviation 0.022	0.034 μg/ml Standard Deviation 0.018	0.035 μg/ml Standard Deviation 0.022	0.030 μg/ml Standard Deviation 0.022
Table 1 Study Specific Characteristic of Serum Carotenoids beta-carotene	0.087 μg/ml Standard Deviation 0.026	0.069 μg/ml Standard Deviation 0.026	0.071 μg/ml Standard Deviation 0.031	0.058 μg/ml Standard Deviation 0.005
Table 1 Study Specific Characteristic of Serum Carotenoids Lycopene	0.106 μg/ml Standard Deviation 0.037	0.092 μg/ml Standard Deviation 0.043	0.104 μg/ml Standard Deviation 0.074	0.098 μg/ml Standard Deviation 0.038

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline and 12 months

Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lutein Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Lutein Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zhiyong Zou

Peking University

Phone: +8610-13581525193

Email: harveyzou2002@bjmu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place