Maximizing Sterol Effectiveness: Study

A recent study, published in Food & Nutrition Research (January 2009), found that while sterols uniformly worked to lower LDL cholesterol, their power is affected by a number of factors. The study assessed 59 randomized clinical trials published from 1992 to 2006. Maximum results were found where patients:

• Consumed 2.5 grams of sterols or stanol per day. The FDA allows a health claim for products containing as little as .4 grams of plant sterols or .65 grams of plant sterol esters. As such, individuals will often need to take multiple servings of plant sterol products to attain the optimum daily intake. Consumption beyond 2.5 grams did not lead to further reductions ( Foods with Plant Sterols).
• Took plant sterols over the course of the day. Multiple servings were generally found to be more effective than a single serving.

Not surprising, sterols lowered LDL cholesterol by more among individuals with high or very high cholesterol levels, but sterols also proved effective among individuals with optimal to borderline-high LDL cholesterol. The authors also sought to assess the power of sterols across different types of foods. While they generally found that foods with some fat content (greater than 3 grams per serving) and low-fat milks and yogurts may be somewhat better, the evaluation does not appear to control for other elements of diet, lifestyle and medications. More research in the role of plant sterols coupled with a broader approach to therapeutic nutrition for cholesterol management is merited.

Kardea Nutrition's Natural Bars for Cholesterol Management

O.K. I have gone off on a policy & political tangent over the past view days. I do think that the events and debates of last week regarding cholesterol medications required that I chime in.

Focusing back to the core goal of Kardea: to develop nutritional tools that enable natural cholesterol management. As a formulation standard we look to multiple product attributes: delicious, convenient, natural, calorie-mindful and therapeutic.

To optimize these attributes, I started looking at those foods that I am likely to eat everyday. If I was already eating, I was likely to keep eating it. If I wasn't already eating, I did not want to add a new source of calories. The trick was how to keep it something I crave while being effective, being therapeutic.

The nutritional bars were a really convenient place to start. Before founding Kardea, I had spent the last 12 years of my life running a specialty chocolate company. I had developed a habit--a craving--for a daily piece piece of dark chocolate (with a late morning cup of coffee--this has to be one of nature's great taste combinations!).

Certainly, dark chocolate is getting good reviews for its cardiovascular benefits. I certainly have tracked this, and discussed it with some people over at the Yale Medical School. This science seems promising, but I am not sure I would yet incorporate chocolate into my program for natural cholesterol management. Instead, I looked to develop a substitute for my morning craving. The Kardea bars achieved this goal, and then some.

First off, I think these bars really are tasty. All natural ingredients such as almond butter, authentic spices like nutmeg, clove or cardamom, real fruit and full flavors.

These bars also provide meaningful levels of plant sterols (1 full gram), fiber (7 grams; 3 grams of heart hearthy soluble fiber) and protein (7 grams total and close to 4 grams of soy protein). The FDA has endorsed these nutrients for their ability to help improve blood lipid profiles including a lowering of LDL (bad) cholesterol.

While only 150 calories each, these bars are more satisfying that the morning chocolate fix. I suspect this is a tribute to the protein and fiber levels.

Further, the bars are sweentened with lower glycemic agave syrup and brown rice syrup. Couple these with the fibers which slow glucose uptake, and I feel that I evened out the sugar spike. So by lunch, I no longer have the urge to eat too fast and too much.

The whole family has been eating the samples through the development process. We all ---friends and family--really enjoy them. Our first production run is now scheduled for mid-February, and they will be available to ship at the end of this month.

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"Cholesterol Drug Bombs"-New York Times Editorial Misses Opportunity

Yesterday, the New York Times editorial board wrote "there have long been suspicions, but it was still very disturbing to learn this week that a heavily promoted cholesterol-lowering drug had flunked a clinical trial of its effectiveness in reducing fatty deposits in arteries....The drug, Zetia, and a combination pill that contains it, Vytorin...generated more than $5 billion in sales last year."

You probably know the ads for Vytorin. They have run on T.V., in magazines and on-line. They certainly are clever, creative and very expensive. According to Nielsen Monitor-Plus, in 2006 the companies spent $136.3 million to advertise Vytorin and $115 million from January to October of 2007.

Vytorin combines Zocor, a statin produced by Merck (and also marketed by generic drug manufactures and sold at lower prices) with the Schering-Plough's Zetia. Statins work by reducing the production of cholesterol in the liver. Zetia works to reduce the absorption of dietary and liver-produced cholesterol from the intestines into the blood stream.

The study compared the effects of treating patients with Vytorin, the combination drug, with a statin alone. The patients all had abnormally high LDL cholesterol. In the study, LDL cholesterol was reduced more significantly by Vytorin than with the statin alone. These results are consistent with the results of a number of other studies.


It also was hypothesized that the added cholesterol-lowering effect of Vytorin would lead to a more significant reduction of arterial plaque growth. This relationship did not hold. The lower cholesterol achieved by the Vytorin did not yield a reduction in plaque build-up as compared to the statin only. In fact, the Vytorin group was found to have a more rapid development of plaque than the statin-only group.

The Times reports that these companies had been “cynically sitting on the results for more than a year” while spending hundreds of millions of dollars to convince consumers that the Vytorin is a preferred cholesterol drug. This certainly is a very legitimate criticism.

The Times continued that "the findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque."


And here is perhaps were the Times should have been somewhat more careful. This study now represents a single set of data among a sea of data that concludes lower LDL cholesterol lowers the risks of heart attacks and strokes. Numerous studies also indicate that LDL cholesterol above 100mg/dl will lead to the development of arterial plaque.

Instead of casting doubt on the general wisdom of cholesterol management, the Times would have served the public well by offseting the barrage of pharmaceutical advertising and reinforce the well-documented science regarding natural alternatives to cholesterol management. An extensive NIH report (http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.htm), for instance, concludes that the "amount of LDL reduction from Therapeutic Lifestyle Changes compares well with many of the cholesterol-lowering drugs." Among the recommendations are the consumption of certain positive nutrients such as plant sterols, soluble fibers, monounsaturated fats in place of saturated and trans fats, and Omega-3s. Needless to say, weight management and exercise is part of the NIH recommendations.

For more information on natural cholesterol management nutritients: http://www.kardeanutrition.com/cholesterol/program.aspx