Results of 5-year NIH study disappoint lutein suppliers

In AREDS2, researchers examined whether adding either lutein plus zeaxanthin, omega-3 fatty acids DHA plus EPA, or both combinations, to the original AREDS formula would help further decrease risk of developing macular degeneration. The results were disappointing, but there are caveats.

Dr. Jeff Anshel

Over at Booth 663 at Supply Side East in early May, OmniActive was taking their "Lutein For Every Age" message to everyone who passed by their booth. In four days, the results of a five-year AREDS2 study were due to come out, and the company's optometrist consultant, Dr. Jeff Anshel, was eagerly waiting the results.

ARED2 is a follow-up study to the original Age-Related Eye Diseases Study (AREDS) sponspored by the National Institutes of Health (NIH). The original AREDS formula reduced AMD advancement by 25 percent, according to the first clinical trial. That formula contained: vitamin C (500 mg), vitamin E (400 IU), beta-carotene (15 mg), zinc (80 mg as zinc oxide) and copper (2 mg as cupric oxide).

Said Taylor Wallace, PhD, senior director of scientific and regulatory affairs for the Council for Responsible Nutrition: "It was so promising, a second stage to the study was added on, to see if the benefits to these supplements could be enhanced any further."

Those studies are now back, published in the Journal of the American Medical Association. The results were, well disappointing. But, keep reading; there are caveats.

In AREDS2, researchers examined whether adding either lutein plus zeaxanthin, omega-3 fatty acids DHA plus EPA, or both combinations, to the original AREDS formula would help further decrease risk of developing macular degeneration (AMD).

“With AREDS2, they were just trying to tweak the formula to see if they could get any additional affects," Wallace said. "So this formulation theoretically still reduces the risk of AMD by 25 percent; that was already factored in at the beginning of this study. Remember, there was no placebo where people weren’t taking anything; even the control group was taking the original AREDS formulation. So we can assume that everybody had a decreased risk by 25 percent. This study was just done to see if there was anything they could do to enhance that effect even more.”

The reason lutein, zeaxanthin and omega-3s were chosen for AREDS2 is because other observational studies have suggested that these nutrients might help stem the progression of late-stage AMD.

AREDS2 was a multicenter, randomized, double-masked, placebo-controlled phase 3 study that enrolled 4,203 participants aged 50 to 85 years, who were deemed to be at high risk of progression to advanced AMD. The study was conducted between 2006 and 2012. All participants were given the original AREDS formula daily, along with one of four additional supplement variations:

  1. Lutein (10 mg) plus zeaxanthin (2 mg);
  2. DHA (350 mg) plus EPA (650 mg);
  3. All four of the nutrients — the lutein plus zeaxanthin, and the DHA plus EPA; or
  4. A control (which was the original AREDS formula).

Subjects’ eye health was evaluated after five years from the start of the study. Neither addition—lutein plus zeaxanthin or DHA plus EPA, nor all four ingredients combined—when added to the original AREDS formula further reduced risk of progression to AMD, researchers said. In total, 1,608 study subjects progressed to advanced AMD, with this breakdown:

  1. 29% for lutein plus zeaxanthin;
  2. 31% for DHA plus EPA, and
  3. 30% for lutein, zeaxanthin, DHA, and EPA combined.
  4. 31% for the control AREDS formula.

Furthermore, neither lutein, zeaxanthin, DHA, nor EPA effected significant changes in visual acuity. DSM Nutritional Products supplied the lutein (Kemin's FloraGLO lutein), zeaxanthin (OptiSharp), and omega-3 DHA and EPA (Ropufa) ingredients for AREDS2.

Lutein and Eye Health

Lutein is an essential nutrient found in breast milk. Since so few young children get adequate amounts of kale and spinach, it is an ideal food to supplement for infants and children, at about 2 mg a day, studies show.

"We really ought to think of lutein as an essential nutrient," Dr. Anshel explained on the expo floor. "Over 80 percent of learning is done through the eyes. Also for sports performance, for the filtering of blue light, as well as for driving ability as people age." In addition to his role as a spokesman for OmniActive, Dr. Anshel is president of the Ocular Nutrition Society.

AMD is the leading cause of blindness in the developed world and accounts for more than 50 percent of all blindness in the United States. Lutein and zeaxanthin are the main components of the macular pigment. DHA is a major structural component of the retina, and EPA may be a precursor to signaling molecules that potentially may influence retinal function.

The Bottom Line

Omega-3 industry association the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT) notes that the study took a treatment-based approach rather than a preventive approach. “Prevention is always more effective than treatment," the association states.

Moreover, it says, “Given the importance of DHA to eye health, the amount supplemented may have been too low to have an effect.”

Wallace, of the Council of Responsible Nutrition, adds, "Age-related eye disease has a long incubation period, and prevention through good nutrition habits should start early and continue throughout a lifespan. Maintaining good nutrition and lifestyle habits most likely have a better chance at preventing chronic disease onset than in halting or correcting a disease progression."

He says that although this study did not report a secondary analysis on the omega-3 arm, that omega-3s are an essential nutrient and one that Americans don't get enough of but should.

As for Dr. Anshel, he is looking forward to an AREDS3. "Limitations of the study include competitive absorption of carotenoids that limited the impact of lutein and zeaxanthin in the presence of beta carotene (which Dr. Chew acknowledged); limited generalizability to less well-educated and well-nourished populations; and that almost all patients elected to take the other-the-counter supplement Centrum Silver, which contains a small amount of lutein and other carotenes and antioxidants. In other words, it seems that the jury is still out on the role of these nutrients in advanced AMD, and this study did not address early AMD or prevention of the disease."

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