Lutien Side Effects and adverse events

Many elderly individuals are now taking lutien supplements daily for many years, and perhaps decades. Do we really know whether it is safe to take a lutien supplement for prolonged periods? Does lutien have any short term or long term side effects? One study evaluated lutien side effects for a period of six months.

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Six month lutien study shows no side effects
The effect of lutien and zeaxanthin supplementation on metabolites of these carotenoids in the serum of persons aged 60 or older.
Invest Ophthalmol Vis Sci. 2006. Khachik F, de Moura FF, Chew EY, Thompson DJ. Department of Chemistry and Biochemistry, Joint Institute for Food Safety and Applied Nutrition (JIFSAN), University of Maryland, College Park, MD, USA.
To investigate the effect of lutien supplementation at doses of 2.5, 5.0, and 10 mg/d for 6 months on distribution of these carotenoids and their metabolites in the serum of elderly human subjects, with and without age-related macular degeneration. To determine whether supplementation with lutien can interact with the serum levels of other dietary carotenoids, retinol, and alpha-tocopherol. Forty-five subjects received daily supplements of lutien (containing 5% zeaxanthin) for 6 months and were followed up for another 6 months after supplementation. Blood was collected at various intervals and lutien, zeaxanthin, and their metabolites in the sera were quantified by normal-phase high-performance liquid chromatography (HPLC)-UV/visible detection. After 6 months of supplementation with 10 mg of lutien, the increases in the mean serum levels from baseline were: 210 to 1000 nM/L for lutien and 56 to 95 nM/L for zeaxanthin. Similarly, the mean concentrations of carotenoid metabolites increased from 49 to 98 for 3-hydroxy-beta,epsilon-caroten-3'-one (3'-oxolutien); 31 to 80 for 3'-hydroxy-epsilon,epsilon-caroten-3-one; and 19 to 25 for epsilon,epsilon-carotene-3,3'-dione. The serum levels of these carotenoids gradually decline within 6 months after supplementation. The increase in the serum levels of lutien / zeaxanthin correlates with increases in the serum levels of their metabolites that have previously been identified in the ocular tissues. Elderly human subjects with and without AMD can safely take supplements of lutien up to 10 mg/d for 6 months with no apparent toxicity or side effects.

Lutien supplement side effects
At this point, it appears that taking a lutien supplement daily for many months does not lead to side effects. However, it is best to limit use to less than 10 mg a day until we have research from longer studies. One possible lutien side effect is the possibility that taking too high a dose may displace the other carotenoids in the retina and cause an imbalance in the retina. You may wish to skip taking your lutien supplement once or twice a week to see if your vision improves on the days when you are not taking it. This way you will know if your daily lutien dose is too high.

Long-term use of beta-carotene, retinol, lycopene, and lutien supplements and lung cancer risk: results from the VITamins And Lifestyle (VITAL) study.
Am J Epidemiol. 2009; Satia JA, Galanko JA, White E. Departments of Nutrition and Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
High-dose beta-carotene supplementation in high-risk persons has been linked to increased lung cancer risk in clinical trials; whether effects are similar in the general population is unclear. The authors examined associations of supplemental beta-carotene, retinol, vitamin A, lutein, and lycopene with lung cancer risk among participants, aged 50-76 years, in the VITamins And Lifestyle (VITAL) cohort Study in Washington State. In 2000-2002, eligible persons (n = 77,126) completed a 24-page baseline questionnaire, including detailed questions about supplement use (duration, frequency, dose) during the previous 10 years from multivitamins and individual supplements/mixtures. Incident lung cancers (n = 521) through December 2005 were identified by linkage to the Surveillance, Epidemiology, and End Results cancer registry. Longer duration of use of individual beta-carotene, retinol, and lutein supplements (but not total 10-year average dose) was associated with statistically significantly elevated risk of total lung cancer and histologic cell types; for example, hazard ratio = 2.02, 95% confidence interval: 1.28, 3.17 for individual supplemental lutein with total lung cancer and hazard ratio = 3.22, 95% confidence interval: 1.29, 8.07 for individual beta-carotene with small-cell lung cancer for >4 years versus no use. There was little evidence for effect modification by gender or smoking status. Long-term use of individual beta-carotene, retinol, and lutien supplements should not be recommended for lung cancer prevention, particularly among smokers.

I bought a lutien 10 mg supplement and noticed some benefit the first few days and then then the initial lutien benefits seemed to decrease. I eat a lot of fresh fruits and vegetables and lots of corn. Am I getting too much of this carotenoid?
   It's possible. We suggest not using a supplement more than three days a week in those whose diet already has lots of fresh produce.