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Re: Its in the Blood

Darrell Miller

5/9/05

Date: May 09, 2005 06:10 PM
Author: Darrell Miller (dm@vitanetonline.com)

It's in the Blood

The National Cholesterol Education Program (NCEP) last July lowered the threshold for considering the use of statin drugs—a move which some say was motivated more by profits than scientific evidence. For example, the Center for Science in the Public Interest pointed out that eight of the nine authors behind the new recommendations had financial ties to statin manufacturers, which stand to reap billions of dollars more from a category that grossed $14 billion in the U.S. last year. And though the Food and Drug Administration (FDA) in January decided against authorizing over-the-counter (OTC) sales of statin drugs, drug companies would still like to see this happen.

“The medical establishment’s pushing of these drugs to becoming the number one category of prescribed drugs in the world has led them to keep lowering the total cholesterol number that triggers the drug recommendation,” said Neil E. Levin, C.C.N., D.A.N.L.A., nutrition educator, product formulator, and “Truth Advocate” for NOW Foods (Bloomingdale, IL), which produces a number of supplements for addressing cholesterol. “This is despite the lack of evidence that total cholesterol means much as regards cardiovascular risks.

“Other tests are much more important in terms of predicting risks, including CRP (C-reactive protein), the balance of different cholesterol fractions, and homocysteine,” he continued. “Add adult-onset diabetes to the risk factors for cardiovascular disease (CVD).”

At the same time, the allegation that enormous sales potential lay behind the lower threshold for prescribing statin drugs illustrates how widespread the problem of hypercholesterolemia (elevated total cholesterol) is. More than 100 million Americans have elevated cholesterol (total cholesterol values of 200 mg/dl and higher), and of these, more than a third have high cholesterol (levels of 240 mg/dl and higher), according to the American Heart Association. Those numbers have unfavorable implications for the incidence of CVD, as high cholesterol is considered a risk factor for coronary heart disease and stroke.

While statin drugs haven’t garnered the same degree of negative publicity that COX-2 inhibitors have suffered lately, safety concerns have arisen nonetheless. For one thing, these drugs lower the liver’s production of coenzyme Q10 (coQ10) along with its production of cholesterol. “CoQ10 is related to energy production and immune functions, is an antioxidant, and [is] an important cardiovascular nutrient,” Levin said. “It is not good to lower one’s coQ10 levels by half!”

Moreover, said Levin, statins increase the tendency of muscle tissues to break down. “Combined with inactivity or certain drugs, this can stimulate muscle wasting,” he said. “Muscle is where a good deal of calories are burned, so a loss of muscle could affect mobility and energy production, potentially adding to obesity problems. These muscle changes occurred in patients and persisted for years after treatment was discontinued, as shown by muscle biopsies, even if no obvious muscle problems were observed by the patients.”

And the last word on the subject may not have been spoken. Predicted Dr. Frank King, Jr. president of King Bio Natural Medicine (Asheville, NC), “Once the appropriate studies are finished, these drugs, along with hypertensives, will hit the fan bigger than the COX-2 inhibitors.”

Also looking toward the future, Levin said that of the 20 million Americans who will be “targeted” for statin drug prescriptions under the new NCEP guidelines, “Some of these will want to try natural methods first. Others will rebel at the side effects of the drugs and experiment with alternative products.”

King and Levin both saw opportunity for natural products in the fallout from drug safety concerns, with King projecting that sales of his company’s cholesterol-related homeopathic remedies will double in 2005. “The reports of deaths from drugs will always overshadow the trumped-up studies and news reports blasting dietary supplements,” said Levin. “Vioxx knocked vitamin E off the media’s radar screens pretty rapidly, though we still see ignorant reporters citing that [Johns Hopkins] vitamin E analysis as if it were true. But the comparable safety of supplements means that open-minded people will want to at least try natural therapies before signing in to a lifetime of drug therapies. Meanwhile, the studies on natural products will continue to build our credibility.”

Those studies keep coming in, with at least four major findings published in the past few months, plus a heart-health claim on walnuts authorized by FDA. They join a raft of earlier findings that link natural products—branded and otherwise—to healthy cholesterol levels.

"Blur of Products"

With so many natural alternatives to cholesterol drugs available, it can be hard to keep track. “As with any other category, the blur of products as they cascade over several shelves means that the retailer needs to have a good sense of what works and what they want to recommend to their customers,” Levin said. “Really, each person needs a protocol that would include antioxidants, fiber, vitamins, herbs, and oils. The pre-mixed cholesterol support formulas are a good starting place.”

To help retailers get a sense of “what works,” here is an alphabetical discussion of several nutrients that have demonstrated benefits in serum cholesterol levels. They include the following:

Barley may help lower cholesterol, according to a report in the American Journal of Clinical Nutrition (2004, vol.80, no.5: 1185-1193). Twenty-five adults with mild hypercholesterolemia consumed a controlled diet low in total fat, saturated fat, and cholesterol for 19 weeks. They then added whole-grain products containing barley to their diets that contained low (0 g), medium (3 g), or high (6 g) amount of beta-glucan per day for five weeks. Total cholesterol was reduced by 4 percent 9 percent, and 10 percent, respectively. The diet with the highest amount of beta-glucan led to a decrease in LDL cholesterol of 17 percent.

Chromium. There’s evidence, Levin said, that chromium in doses of 500 mg a day may decrease levels of low-density lipoprotein (LDL, the so-called “bad” cholesterol) and total cholesterol while raising levels of high-density lipoprotein (HDL, or “good” cholesterol). At the annual meeting of the American College of Nutrition last October, a poster presentation on the safety of Benicia, CA-based InterHealth Nutraceuticals’ ChromeMate niacin-bound chromium won first prize; among other things, the presentation cited chromium’s role in maintaining healthy blood lipid levels.

Fatty Acids. The latest in a long line of studies demonstrating the benefits of fatty acids in heart health is a study published in The International Journal of Clinical Pharmacology and Therapeutics in December 2004. It showed that docosahexaenoic acid (DHA), an omega-3 fatty acid, can restore normal blood vessel function in children with inherited high cholesterol. The study, which used Martek DHA produced from microalgae, concluded that restoration of normal blood vessel function has the “potential for preventing the progression of early coronary heart disease in high-risk children.”

“The evidence continues to accumulate on the cardiovascular benefits of DHA for people of all ages,” said Henry “Pete” Linsert, Jr., chairman and CEO of Martek Biosciences, an ingredient supplier based in Columbia, MD. “This study clearly indicates that DHA played an important role in healthy blood vessel function in the children in this study.”

On the Omega-Research.com Website maintained by fish oil manufacturer Nordic Naturals (Watsonville, CA) can be found summaries of several earlier studies linking omega-3 fatty acids to maintaining healthy blood lipid levels, as well as related benefits such as elasticity of the arteries. In a 2003 study published in the American Journal of Clinical Nutrition, it was found that women receiving a mixture of 4 g eicosapentaenoic acid (EPA) and DHA along with 2 g of gamma-linolenic acid (GLA) had lower levels of LDL cholesterol after 28 days compared to those who received either the EPA/DHA supplements without DHA, EPA/DHA with a smaller dose of GLA, or GLA alone.

Flax is another source of omega-3s, and Arkopharma/Health From The Sun (Bedford, MA) offers FiProFlax in a variety of forms. Marketing director Hugues P. Mas said the flax is “QAI [Quality Assurance International] certified organic and guaranteed GMO [genetically modified organism]-free.” On its Website, the company offers a cholesterol quiz geared to consumers, discussing the importance of omega-3s as well as other nutrients.

Garlic. Adding to an already considerable body of research demonstrating that garlic can lower total cholesterol, LDL cholesterol, and triglycerides while increasing HDL cholesterol, researchers at UCLA in 2003 reported that Kyolic aged garlic extract reduced or inhibited plaque formation in the arteries of 19 cardiac patients taking statin drugs.

Lead researcher Matthew Budoff, Ph.D. commented at the time that the study “suggests that aged garlic extract may be a useful and beneficial dietary addition for the people who have high cardiovascular risk or who have undergone heart surgery.” Budoff has since presented several trade show seminars sponsored by Los Angeles-based Wakunaga of America, the makers of Kyolic.

Guggul. In use for centuries as a component of Ayurvedic medicine, guggul—a gummy resin tapped from the Commiphora mukul tree, which is native to India—has been studied since the early 1960s for its hypolidemic (blood-lipid lowering) properties. Sabinsa Corp. (Piscataway, NJ), an ingredient supplier which produces a standardized extract under the brand name Gugulipid, says the studies on guggul indicate that its hypolipidemic activity can be attributed to more than one mechanism of action.

Among the possible mechanisms are: inhibition of cholesterol biosynthesis, enhancing the rate of excretion of cholesterol, promoting rapid degradation of cholesterol, thyroid stimulation, alteration of biogenic amines, and “high affinity binding and anion exchange.”

Homeopathy. “Homeopathy activates the body’s own control system to work properly,” said King. “This is the safest and most curative approach to take.

“Forcing the body into biochemical change even naturally doesn’t actually have the curative action of homeopathy,” King continued. “Homeopathy can even correct the genetic predispositions to disease we may have inherited from as deep as a thousand years into our family chain.” King Bio makes Artery/Cholesterol/BP, a homeopathic formula intended to help tone heart muscles and blood vessels.

Low glycemic index foods. In a study published in the February issue of the American Journal of Clinical Nutrition, researchers found that high glycemic load is negatively correlated to serum levels of HDL cholesterol. Assessing the relationship between blood levels of lipids and diet in a test population of 32 healthy males and females ages 11 to 25, the researchers found that glycemic load accounted for 21.1 percent of the variation in HDL cholesterol. They concluded that glycemic load appears to be an important independent predictor of HDL cholesterol in youth and noted that dietary restrictions without attention to glycemic load could unfavorably influence blood lipids.

Medicinal Mushrooms. Although its product SX-Fraction is intended primarily to address high blood sugar, Maitake Products, Inc. (MPI, Ridgefield Park, NJ) found in a clinical study that LDL cholesterol in diabetic patients declined modestly (from 142 mg/dl to 133 mg/dl) over a two-month period. Those taking SX-Fraction also lost about 7 lbs. in the same time period.

“The more impressive lowering of cholesterol, however, comes from the dietary fiber that is found in all medicinal mushrooms,” said Ellen Shnidman, manager of scientific affairs at MPI. She cited animal studies which documented the cholesterol-lowering properties of four different mushrooms: maitake, shiitake, agaricus, and enokitake.

For example, a study reported in the September 1996 issue of Alternative Therapies showed “a 44 percent reduction in total cholesterol in rats consuming maitake mushroom in their diet,” said Shnidman. “This cholesterol reduction is accompanied by weight loss, relative to rats eating a similar high-choelsterol diet without mushrooms. Apparently, cholesterol is excreted by the rats in sufficient quantity to aid in weight loss.”

Oat bran. A 2004 consumer study conducted by the Natural Marketing Institute (NMI, Harleysville, PA) for Nurture, Inc. (Devon, PA), which produces the ingredient OatVantage, found that 63 percent of consumers managing their cholesterol levels prefer oat-based ingredients.

Oat bran is the subject of a health claim authorized by FDA in 1999, and NMI research found that 69 percent of respondents preferred the FDA-permitted health claim, “Helps Lower Cholesterol,” over the model structure-function claim, “Helps Maintain Healthy Cholesterol Levels.” “This is significant for food, beverage, and dietary supplement manufacturers who want to increase sales by using a more consumer-desired claim on the product label,” said Griff Parker, Nurture CEO.

Plant sterols. Also the subject of an FDA-approved claim for heart health, plant sterols (structurally similar to cholesterol in humans) can block the absorption of cholesterol, according to a number of studies. In an “Ask the Doctor” publication (available online at www.atdonline.org), Decker Weiss, N.M.D. noted that sterols enter the same receptor sites that cholesterol enters on its way to the bloodstream. “The cholesterol, being blocked from absorption, remains in our intestines where it is eventually excreted,” Weiss wrote. General Mills has just introduced Yoplait Healthy Heart, a yogurt high in plant sterols.

Policosanol. A mixture of fatty alcohols derived from sugar cane or beeswax, policosanol has been favorably compared in clinical studies to several types of prescription drugs for managing cholesterol. On its own, policosanol was found in a 1999 study to reduce LDL cholesterol while raising levels of HDL cholesterol.

Probiotics. “Several studies have indicated that consumption of certain cultured dairy products resulted in reduction of serum cholesterol, as well as triglycerides,” wrote Dr. S.K. Dash, president of probiotic manufacturer UAS Laboratories (Eden Prairie, MN), in his Consumer Guide to Probiotics. Among other studies, Dash cited two controlled clinical studies from the VA Medical Center at the University of Kentucky.

“In the first study, fermented milk containing [Lactobacillus] acidophilus was accompanied by a 2.4 percent reduction of serum cholesterol concentration,” he wrote. “In the second study, a different L. acidophilus strain reduced serum cholesterol concentration by 3.2 percent. Since every 1 percent reduction in serum cholesterol concentration is associated with an estimated 2 to 3 percent reduction in risk for coronary heart disease [CHD], regular intake of fermented milk containing an appropriate strain of L. acidophilus has the potential of reducing risk for [CHD] by 6 to 10 percent.”

Dash said his company’s DDS Probiotics contain DDS-1 L. acidophilus, “which has been researched and demonstrated to show cholesterol-lowering effect.”

Psyllium. “Internal cleansing is very important” in maintaining healthy cholesterol levels, “especially if you do it with a lot of fiber,” said Sunil Kohli, vice president of Chino, CA-based Health Plus, Inc. The cholesterol-managing ability of fiber in general and psyllium in particular is “very well-established,” he said.

However, Kohli said, “It will probably do you no good if it’s random. It should be done on a regular basis, and it should be supervised. Consulting the doctor or pharmacist is important.”

Soy. The protein in soy “has evidence of lowering total cholesterol and LDL cholesterol, based on reviews of studies using over 20 g of soy protein per day,” said Levin. “Soy isoflavones are considered only partly responsible for this effect.”

Sytrinol. A patented proprietary formula derived from natural citrus and palm fruit extracts and containing citrus polymethoxylated flavones and palm tocotrienols, Sytrinol has been shown in clinical trials to improve total cholesterol, LDL cholesterol, and triglycerides by up to 30 percent, 27 percent, and 33 percent, respectively. Having just wrapped up Phase III of a long-term trial of Sytrinol, Chicago-based SourceOne Global Partners, which owns the exclusive worldwide license for intellectual property associated with the ingredient, is commencing a study that combines Sytrinol with plant sterols.

Tocotrienols. On its Website discussing the science and benefits of tocotrienols (www.tocotrienol.org), ingredient supplier Carotech Inc. (Edison, NJ) identifies several benefits for blood lipid levels. Tocotrienols, according to the Website, have been shown to “inhibit cholesterol production in the liver, thereby lowering total blood cholesterol;” “[suppress] hepatic HMG-CoA reductase activity [and result in] the lowering of LDL cholesterol levels;” and “inhibit cholesterogenesis by suppressing HMG-CoA reductase.”

New Weapons

There are also nutrients that are emerging as potential weapons in the fight against cholesterol. Levin cited rice bran oil, resveratrol, pantethine, l-carnitine, and niacin as showing promise.

With all of this, Levin said, it’s important for retailers to remember that “they are not allowed to discuss diseases and remedies unless there is an approved FDA health claim allowed on the label, as with soy protein and plant sterols. What is allowed are structure-function claims such as ‘cholesterol support,’ ‘promoting normal, healthy circulation,’ ‘homocysteine regulators,’ etc.”

Supplementation is only one tool for managing cholesterol levels, manufacturers pointed out. “Besides nutrition, lifestyle is a key to controlling cholesterol,” Levin said. “Eating a variety of antioxidant-rich foods will prevent the liver from churning out cholesterol as a ‘cheap’ antioxidant. The body uses oxidized cholesterol to patch leaky and damaged blood vessels, so the ability to build healthy collagen is a must, using nutrients like vitamin C, Pycnogenol, rutin, hyaluronic acid, and MSM.

“Don’t forget exercise and stress reduction,” he added. “Stress results in high cortisol levels—usually accompanied by poor blood lipid levels—and a lack of good sleep to produce unhealthy people.” VR

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