Phase 3
Completed N=192
Effects of Lutein Supplementation on Subclinical Atherosclerosis
Carotid atherosclerosis · Carotid Intimal Medial Thickness 1
Source: ClinicalTrials.gov NCT01534533 ↗
Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Table 1 Study Specific Characteristic Part One — 69.8; 59.8; 59.1; 72.7 Percentage of Participants — p=>0.05
Summary
This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Table 1 Study Specific Characteristic Part One |
69.8; 59.8; 59.1; 72.7; 100; 100 | >0.05 |
| PRIMARY Table 1 Study Specific Characteristic of Age |
57.4; 57.4; 57.3; 53.8 | 0.992 |
| PRIMARY Table 1 Study Specific Characteristic of Body Mass Index (BMI) |
25.3; 25.4; 24.8; 24.1 | 0.672 |
| PRIMARY Table 1 Study Specific Characteristic of Blood Pressure (BP) |
129.7; 125.5; 126.0; 117.7; 82.6; 80.5 | 0.402 |
| PRIMARY Table 1 Study Specific Characteristic of Serum Carotenoids |
0.17; 0.19; 0.20; 0.18; 0.034; 0.034 | 0.636 |
| SECONDARY Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months |
— | — |
| SECONDARY Dietary Intake of Energy During the Study Periods |
— | — |
| SECONDARY Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01534533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.