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From The January 2001 Issue of Nutrition Science News
Shelf Stockers for 2001
by Ken Babal, C.N.
Researchers investigate. Suppliers and manufacturers produce. Marketers sell. By year's end, a few new supplements ought to make it to the tops of store shelves.
Every year, hundreds of new herbs, phytonutrients and nutraceuticals enter the market—each vying for the attention of storekeepers, health care practitioners, consumers, and, last but not least, the media. Compiling a list of the most important new products requires an examination not only of the products themselves, but also of consumer and industry trends, new research, marketing plans, and media coverage—as well as some crystal-ball gazing.
Numerous products are worthy of attention this year but, for the moment, may lack one or more of the forces necessary to drive them into consumer consciousness. For the record, my forecasts from the last few years have featured such products as colostrum, IP-6, tocotrienols, black cohosh, folic acid, growth hormone enhancers, medicinal mushrooms, beta-glucan and systemic enzyme supplements. On the whole, not a bad track record. Some, such as colostrum and beta-glucan, have seen increased sales; medicinal mushrooms sell steadily; tocotrienols, despite one company's multimillion-dollar launch, have not caught on as well. So, what might the new year show us?
With $7.4 billion in anti-depressant drug sales worldwide,1 it should come as no surprise that natural alternatives St. John's wort (Hypericum perforatum) and S-adenosylmethionine (SAMe) would score big with consumers in 1999 and 2000. Likewise, the successful 1998 introduction of the anti-impotence drug sildenafil (Viagra) spurred sales of herbal aphrodisiacs such as yohimbe (Pausinystalia yohimbe), Siberian ginseng (Eleutherococcus senticosus), and maca (Lepedium meyenii)—although the jury is still out on their efficacy.
Another successful entry into the pharmaceutical market was Pharmacia & Upjohn's tolterodine (Detrol) for incontinence. As of yet, no supplement companies have attempted to capitalize on the publicity of this pharmaceutical, but some members of Germany's Commission E, a panel that evaluates the therapeutic value of herbal medicines, believe butterbur (Petasites vulgaris or P. hybridus) might be a candidate. Butterbur also recently has been shown to have efficacy in human migraine prevention.2 Other clinical studies have examined its utility in treating ashma and bronchitis.3 No clinical or animal studies have been conducted on its possible beneficial effects on urinary incontinence, although butterbar has folklore-based use for this condition.
COX-2 Inhibition
Analysts agree that top-selling drugs share two traits: They have to be prescribed by more than one type of doctor—ideally a general practitioner and a specialist—and they should treat a condition lacking in new remedies. In 1999, the two most anticipated introductions into the pharmaceutical market were COX-2 inhibitor drugs celecoxib (Celebrex) and rofecoxib (Vioxx), prescribed to treat the pain and inflammation of osteo- and rheumatoid arthritis. As with other blockbuster drugs, their financial successes have already given rise to natural alternatives.
COX-2 is short for cyclooxygenase-2, one of the key enzymes that helps the body produce the inflammatory hormonelike compounds prostaglandins and cytokines. COX-2 is activated by injury and inflammation and is essential for fighting infections and healing injuries, but when the body produces too much, the result is chronic inflammation and pain, such as often manifests as arthritis.
The usual approach to alleviating pain from osteo- and rheumatoid arthritis is to take nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin. NSAIDs ease inflammation by inhibiting the activity of COX-2. However, these drugs also inhibit COX-1, another form of the enzyme that produces prostaglandins that specifically protect cells in the kidneys and stomach. Thus, NSAIDS such as aspirin end up eroding the lining of the stomach and causing gastrointestinal bleeding. One study suggested that as many as 16,500 people die each year because of NSAID-induced GI bleeding.4 Thus, the motivation behind designing selective COX-2 inhibitors is to produce a drug that reduces inflammation without side effects. This has paid off big for drug companies. Since their introduction, doctors have written more than 7 million prescriptions for these "super aspirins" that have earned hundreds of millions of dollars for the manufacturers.
Although COX-2 inhibitors do not require the same ulcer warning that other painkillers must carry, FDA advisors say that too few people have taken them long enough to know their long-term safety. Also, it should be noted that COX-2 inhibitors do not inhibit platelet stickiness or aggregation, so they don't provide aspirin's stroke or heart attack protection.
The Wall Street Journal (Oct. 18, 1999) hailed COX-2 inhibition as the next major milestone in preventive medicine, while The New York Times (Jan. 18, 2000) acknowledged it as a method of preventing cancers of the bladder, colon, esophagus and skin.
Certain herbs contain phytonutrients that appear to safely and significantly inhibit COX-2. Examples are turmeric (Curcuma longa),5 holy basil (Ocimum sanctum),6 and green tea (Camellia sinensis).7 Dietary supplement manufacturers offer anti-inflammatory herbs singularly and in formulations, usually in extract form.
Omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are found in cold-water fish, also modulate the inflammatory COX-2 process. Inflammatory prostaglandins such as PGE-2 are created out of the interaction of arachidonic acid (found in the body as well as in meat, milk, and eggs) with COX-2 and COX-1. Omega-3 fatty acids compete with pro-inflammatory arachidonic acid and have been shown to alter prostaglandin production, thereby quelling the inflammatory response.
Many practitioners recognize that it may be impractical to consume the high therapeutic dose of omega-3 fatty acids through diet alone. Indeed, most studies have used omega-3 fish oil supplements to influence inflammation. However, supplements often come with a fishy taste and fishy burps.
A recent innovation is a good-tasting, fruit-flavored, puddinglike fish oil emulsion that comes in handy, individual-dose, oxidation-resistant squeeze packets. This formulation significantly reduces the unpleasant fishy aftertaste and assures stability and potency of the product as well as better patient compliance. People who experience discomfort from fish oils may also try algae-derived DHA, though it is much less efficacious as an anti-inflammatory agent than EPA.
Blockbuster Botanicals
While some supplement categories have taken a downturn in sales, the botanical category has held steady in the wake of market growth surges in 1997 and 1998. This is partly due to national television advertising and because many consumers perceive herbs as safer alternatives to drugs. In some cases, positive media coverage has helped boost awareness of particular herbs.
Ginger(Zingiber officinale) received a reserved thumbs-up last year from The Washington Post, a newspaper considered unfriendly to what it calls the "unregulated dietary supplement industry." The paper acknowledged that ginger is effective for combating motion sickness and enumerated its uses in traditional herbal systems for headaches, stomach problems, colds, urinary-tract infections, malaria and yellow fever, in addition to detoxifying infections. However, the story said there is no proof ginger can work as an anti-inflammatory.
New FDA structure/function regulations allow claims for ginger as a remedy only for motion sickness and temporary nausea. Pharmacists should note that researchers at Texas Tech University Health Sciences Center in Amarillo report that ginger should not be used concomitantly with warfarin sodium, an anticoagulant, because ginger can prolong bleeding time since it slows the process of blood clotting.8
MoringA (Moringa oleifera) received a boost when the Los Angeles Times wrote about this versatile tree that has multiuse properties equivalent to corn and soy as well as medicinal benefits. Corn yields oil, sugar, flour, cereal, livestock fodder, distilled spirits and vitamin C supplements, to name just a few. Soy also provides a diverse array of products from tofu to soy ink. Moringa, practically unknown except to botanists and people of developing countries, runs a similar gamut of resulting products. It is a common tree that thrives in both the desert and the living room and produces leaves, seeds, and flowers—each with different actions.
Even the wood of the moringa tree yields a common blue dye. Because moringa oil won't spoil, it is used as a natural preservative and even as a machinery lubricant. Moringa also turns up as animal feed, plant fertilizer, stationery and oil paint. The crushed seeds have coagulating properties, making moringa useful for domestic rural water purification in tropical areas.9 The seeds appear to work better than the common water purifier aluminum sulfate, which can be toxic.
The beneficial properties of moringa have been known for years, but only lately has it picked up a devoted following. Scientists have been putting moringa to the test, and relief organizations are cultivating it and promoting it as a national food in poor countries such as Senegal and India.
The moringa tree has an outstanding array of dietary benefits including a good nutritional profile. The dried leaf powder contains as much as twice the beta-carotene found in carrots. For this reason, the International Eye Foundation, based in Bethesda, Md., is using it in Malawi to prevent childhood blindness. Ounce for ounce, the leaves have more than three times the calcium of milk, slightly more potassium than bananas, more than twice the iron of spinach, and more than twice the vitamin C of oranges. In addition, the dry leaves contain 17 percent protein and compare favorably to the World Health Organization's standard for essential amino acids.10 The leaves are also a good source of B vitamins and are low in fat and carbohydrates.11
Moringa is also valued for its medicinal properties. Doctors use it to treat diabetes in West Africa.12 Pakistani researchers have isolated compounds including beta-sitosterol that show hypotensive activity; indeed, it is used in India to treat high blood pressure.13 The seeds and roots contain an antibiotic that shows effectiveness against skin infections.14 Ingesting the root and root bark, however, is toxic because they contain a nerve paralyzer.
At present, moringa supplements may be difficult to find, appearing occasionally in Ayurvedic formulas for immune support. Expect to see powders that can be added to baby food, soups, and vegetables, which can adds nutrition without changing the taste. Its popularity is expected to grow more from government efforts to cultivate it, coupled with favorable press in such publications as the Los Angeles Times and National Geographic, than from any new study in particular.
Black Cumin (Nigella sativa) seed has a history that dates back 3,000 years, yet few people in the United States have heard of it. References to black cumin seed can be found in some of the oldest religious and medical texts. It is believed to be indigenous to the Mediterranean but is cultivated in other parts of the world including Saudi Arabia, northern Africa, and parts of Asia.
Avicenna (980-1037), the renowned Persian philosopher and physician who wrote the classic text, The Canon of Medicine, refers to black cumin seed as the seed "that stimulates the body's energy and helps recovery from fatigue or dispiritedness." Traditionally, black cumin seed has been used for a variety of ailments including asthma, bronchitis, headache, stomachache, rheumatism and related inflammatory conditions. Generally, the seeds are added to food or ground and mixed with honey. Its oil is used to treat skin conditions such as eczema and boils. For head colds, it is rubbed on the forehead and sides of the face close to the ears. The Arabic text Medicines of the Prophets lists as many as 50 illnesses for which black cumin seed has demonstrated effective healing qualities. Its many uses have earned it the Arabic approbation "seed of blessing."
Ongoing research has fueled public interest in black cumin seed, particularly in Austria and Germany where it is sold in most natural products stores. One recent study showed that black cumin seed oil has a protective effect against ethanol-induced ulcers in rats. Ulcer-induction reduced acidity and glutathioine levels, while significantly increasing mucosal histamine content. Animals pretreated with black cumin seed oil before ulcer induction experienced significantly increased acidity and glutathione levels, and significantly decreased gastric mucosal histamine content, resulting in a protection ratio of 54 percent compared with the ethanol group.15
The primary active components of black cumin seeds are the volatile oils thymoquinoline and dithymoquinone.16 These phytochemicals strongly inhibit lipoxygenase17 and prevent the release of histamine from mast cells.18 Histamine often causes allergic reactions and is associated with respiratory conditions such as bronchial asthma. In laboratory experiments, the compounds in black cumin seed oil also have inhibited tumor cells—even those resistant to anti-cancer drugs.16
L-Theanine is the amino acid in green tea (Camellia sinensis) that balances caffeine's effects and accounts for the sense of relaxation delivered by green tea.19 Although theanine research is promising, it is still preliminary, and no systematic, definitive studies have been conducted. Green tea is a source of several important compounds including polyphenols and caffeine. Theanine is found only in the mushroom Xerocomus badius and the tea plant, in which it exists in the free (non-protein) amino acid form.
Alpha-wave generation in the brain is considered an index of relaxation. In one study, 50 females between 18 and 22 years old were divided into high-anxiety and low-anxiety groups. Each group was given water, 50 mg theanine solution or 200 mg theanine solution once a week for two months. Brain waves were measured for 60 minutes after each administration. Within 40 minutes, a significantly greater amount of alpha waves were generated on the brain surface of the theanine groups, signifying relaxation without causing drowsiness.20 The mechanism involved appears to be the way theanine affects the metabolism or the release of the neurotransmitters dopamine and serotonin.
Japanese researchers at the University of Shizuoka administered theanine to hypertensive rats and observed a dose-dependent decrease in blood pressure. A significant decrease was observed using doses at and greater than 1,500 mg/kg body weight.21 (For the record, this would be considered a gigantic dose.) Although blood pressure can be affected in several ways, researchers speculate that theanine might affect pathways such as the peripheral nervous system and peripheral blood vessels. Thus, theanine might have a calming effect on the mental state by lowering blood pressure.
Until recently, theanine was not available commercially because of production difficulties. A few companies, however, have succeeded in developing an enzymatic process to manufacture theanine on an industrial scale. In Japan, it appears as an ingredient in candies, gum and beverages designed to induce relaxation, improve learning, and to offset a bitter taste in some food materials. In the United States, expect to see theanine in products marketed for anxiety, stress, and exercise recovery in both dietary supplement and beverage form.
Many new products demonstrating important physiological actions are presently in the pipeline or newly emerging in the marketplace. Botanicals, and in particular phytochemicals teased from plants, are an area of growing research, and as relevant clinical trials proceed, the information they produce will doubtlessly translate to new and novel products becoming available to consumers. We can only educate ourselves and our clients and in the process to ascertain the best applications.
Ken Babal, C.N., has a clinical nutritionist practice in Los Angeles and is staff nutritionist for Erewhon Natural Foods Market in Los Angeles. His latest book is Good Digestion: Your Key to Vibrant Health (Alive, 2000).
References
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2. Grossmann M, Schmidramsl H. An extract of Petasites hybridus is effective in the prophylaxis of migraine. Int J Clin Pharmacol Ther 2000 Sep;38(9):430-5.
3. Ziolo G, Samochowiec L. Study on clinical properties and mechanisms of action of Petasites in bronchial asthma and chronic obstructive bronchitis. Pharm Acta Helv 1998 Feb;72(6):379-80.
4. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105(1B):31S-8S.
5. Plummer S, et al. Inhibition of cyclo-oxygenase 2 expression in colon cells by the chemopreventive agent curcumin involve inhibition of NF-kappaB activation via the NIK/IKK signalling complex. Oncogene 1999;18(44):6013-20.
6. Suh N, et al. Novel triterpenoids suppress inducible nitric oxide synthase (iNOS) and inducible cyclooxygenase (COX-2) in mouse macrophages. Cancer Res 1998;58(4):717-23.
7. Haqqi T, et al. Prevention of collagen-induced arthritis in mice by a polyphenolic fraction from green tea. Proc Natl Acad Sci 1999;96(8):4524-9.
8. Miller LG. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Arch Intern Med 1998 Nov 9;158(20):2200-11.
9. Jahn SA. Proper use of African natural coagulants for rural water supplies. Manual No. 191, Publ: GTZ, Eschborn, Germany. 1986.
10. Freiberger CE, et al. Nutrient content of the edible leaves of seven wild plants from Niger. Plant Foods Hum Nutr 1998;53(1):57-69.
11. Price ML. The moringa tree. Educational concerns for hunger organization technical bulletin 1985;2,6.
12. Fritz M. A common tree with rare power. Los Angeles Times 2000 Mar 27;partA:1.
13. Faizi S, et al. Hypotensive constituents from the pods of Moringa oleifera. Planta Med 1998 Apr;64(3):225-8.
14. Eilert U, et al. The antibiotic principle of seeds of Moringa oleifera and Moringa stenopetala. Planta Res 1981;42:55-61.
15. El-dakhakhny M, et al. Effects of Nigella sativa oil on gastric secretion and ethanol induced ulcer in rats. J Ethno-pharmacol 2000 Sep 1;72(1-2):299-304.
16. Worthen DR, et al. The in vitro anti-tumor activity of some crude and purified components of blackseed, Nigella sativa L. Anticancer Res 1998;18:1527-32.
17. Houghton P, et al. Fixed oil of Nigella sativa and derived thymoquinone inhibit eicosanoid generation in leukocytes and membrane lipid peroxidation. Planta Med 1995;61:33-6.
18. Chakravarty N. Inhibition of histamine release from mast cells by nigellone. Ann Allergy 1993;70:237-42.
19. Kimura R, et al. Influence of alkylamides of glutamic acid and related compounds on the central nervous system. I. Central depressant effect of theanine. Chem Pharm Bull 1971;19:1261-7.
20. Ito K, et al. Effects of L-theanine on the release of alpha brain waves in human volunteers. Nippon Nogeikagaku Kaishi 1998;72:153-7.
21. Yokogoshi H, et al. Reduction effect of theanine on blood pressure and brain 5-hydroxyindoles in spontaneously hypertensive rats. Biosci Biotechnol Biochem 1995;59:615-8.
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