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August 2003

Lycopene: New health claim
petition filed with FDA


According to the National Institutes of Health, cancer costs the American public approximately $156.7 billion a year in direct medical costs, indirect morbidity costs and indirect mortality costs. Reducing incidents of cancer will not only save lives but significantly curtail our spiraling health care costs. Increasingly, scientific studies indicate that lycopene, a member of the carotenoid family, may reduce the incidence of prostate, lung and stomach cancers.

In an effort to make this research available to the public, attorneys at Emord & Associates filed a health claim petition with the FDA requesting that the FDA allow the use of various health claims for lycopene. The petition states, "The mechanism of lycopene's anticarcinogenic activity has demonstrated that lycopene reduces oxidative stress. Lycopene has the ability to quench singlet oxygen, trap peroxy radicals, inhibit the oxidation of DNA, inhibit lipid peroxidation and inhibit the oxidation of low-density lipoprotein. Lycopene has been shown to have the highest antioxidant activity of all the cartenoids.

Over seventy clinical trials have evaluated the effects of lycopene supplementation on the incidence of cancer. There is significant and strong scientific evidence that lycopene reduces the risk of certain forms of cancer; the evidence is strongest for reduction in the risk of prostate and lung cancers, but the evidence is suggestive for colon, stomach, cervix, breast, oral cavity, pancreas and esophagus cancers. The most supportive studies are the Harvard Physicians' Study and the Health Professional Follow-Up Study. Those studies measured the effect of a tomato product and lycopene intake on prostate cancer risk reduction and tracked blood levels of lycopene. The results of the Harvard Physicians' Study provide strong evidence that increased consumption of tomato products and other lycopene-containing foods might reduce the occurrence or progression of prostate cancer since in this study blood levels of lycopene confirmed earlier associations of dietary intake of tomato products and lycopene with reduced prostate cancer risk."

If successful, this petition will allow any food product or nutritional supplement containing lycopene or tomatoes to make health benefit claims for these substances.

Omega-3-fatty acids reduce risk of AMD

Age-related macular degeneration (AMD), is a major cause of central vision loss in the elderly. Treatments are limited and hope lies in reducing the risk of the disease and preventing its development. A study reported at the Annual Meeting of the Association for Research in Vision and Ophthalmology, in Florida, May, 2003, provides new data supporting the effects of diet and nutrients, in lowering the risks of having a type of AMD that leads to blurred vision, and in severe cases, blindness. The study was carried out by Dr. JP SanGiovanni and colleagues from the National Eye Institute, in Bethesda MD. It showed a higher intake of omega n-3 polyunsaturated fatty acids and fish was associated with decreased risk of having neovascular AMD.

Approximately 1.7 million people over 64, suffer from the severe form of AMD, that leads to blindness. The macula is an area located in the center of the retina and is responsible for fine and detailed central vision.

The Age-related Eye Disease Study, reported at the meeting, was a case control retrospective study of 4,513 participants, aged 60 to 80 years. Subjects completed a self administered food questionnaire, and provided information on the frequency and portions of fish intake in the last year, as well as other health and lifestyle data. The types of fish considered, included fried fish or fish sandwiches, tuna salad or tuna casserole, oysters, other shell fish and broiled or baked fish. People without AMD served as control groups for each of the four different types of AMD tested.

The result showed that highest total fish consumption (compared to no intake), of more than two servings a week, of broiled or baked fish or of tuna, reduced the risk of having neovascular AMD, but not other types of AMD, by approximately 50%.

When assessing AMD risk in relation to intake of omega-3-fatty acids, that are high in marine products, the results showed that risk for neovascular AMD, but not other types of AMD, was significantly decreased, by approximately 60%, for people with the highest intake of total omega-3-fatty acids (highest quintiles versus lowest quintiles). A similar risk reduction (approximately 53%), was found with intake of docosahexaenoic (DHA), an omega-3-fatty acid, that is selectively taken up and retained in the photoreceptors of the eye.

The studies indicate an independent association between fish intake and omega-3-fatty acids intake and neovascular AMD, showing that high intake of fish, or omega-3-fatty acids, halves the risk of having the disease.

-Carmia Borek, Ph.D.

Neuroprotective effects of garlic

The praised health benefits of garlic include cardiovascular protection, stimulation of immunity and anticancer effects. Now, new experiments show that garlic, in the form of aged garlic extract (Kyolic), prevents the death of neurons, the hallmark of age-related dementias and Alzheimer's disease (AD). The studies, presented at the meeting of the Federation of the Societies for Experimental Biology, in San Diego, April 15, 2003, suggest that garlic has neuroprotective effects that may help prevent neurodegenrative conditions.

Alzheimer's disease is the most common form of progressive dementia. Its pathological markers in the brain, are deposits of amyloid-beta (A-beta) protein, a 39 to 43 amino acid peptide, evidence of oxidative damage and cell death. The death of neurons can occur following ischemia, when a deficiency in blood supply to the brain deprives cells of oxygen and glucose. Neuron death is triggered by oxidative stress, induced by A-beta, and by apoptosis, a genetically programmed cell suicide, where events, including oxidation, activate a series of enzymes called caspases, among them caspase 3. In a final blow to the cell caspase 3 cleaves critical cellular proteins and triggers its suicide.


At the meeting, studies from the Korea Food Research Institute showed that the water soluble organosulfur S-allyl cysteine (SAC), that is present in low amounts in fresh garlic, and enriched in aged garlic extract, prevents cell death following ischemia. Model cultures of human neurons (neuroblastoma) were fed SAC or served as control. Both cultures were then exposed to simulated ischemia, by oxygen and glucose deprivation (hypoxia and hypoglycemia), followed by re-oxygenation, a step that stimulates free radical damage. Results showed that SAC, a potent antioxidant, protected the cells and significantly increased neuronal survival, compared to controls. In a second set of experiments, gerbils were exposed to ischemia and reoxygenation, by tying and then releasing their carotid arteries. The animals were treated with SAC before ischemia and after reoxyenation (reperfusion). Seven days later, researchers found that SAC-treatment increased neuronal survival by 30%, compared to control, in the hippocampus, the area in the brain responsible for memory.

In addition, studies published in the May issue of Neuroscience Research show that S-allyl cysteine, in a concentration dependent manner, protects PC12 cells against A-beta induced oxidative death. Aged garlic extract is rich in antioxidants, as the aging and extraction process increases the levels of water soluble organosulfur antioxidants, such as S-allyl cysteine, and generates new compounds including allixin.

To be effective in protecting the health of brain cells and preventing decline in cognition, a nutrient must act on several fronts. The new studies show that garlic, in the form of the standardized aged garlic extract supplement (Kyolic), and its major water soluble component, S-allyl cysteine, exert a combination of antioxidativeand anti-amyloid beta, providing neuro-protection, that may help prevent the onset of neurodegenerative conditions, including Alzheimer's disease.

-Carmia Borek, Ph.D.

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