Cardiovascular Health: Formulating to Lower Cholesterol

Just as we have many products on grocers’ shelves that promote a myriad of benefits for a multitude of health conditions, we are seeing increased demand for nutrition that strategically promotes heart health. There are a host of considerations for food and beverage developers looking to incorporate specific nutrients into products that help lower cholesterol. These include responsible examination of interactions as well as synergies between various ingredients. Certain ingredients, when used together, may enhance their cholesterol-lowering effects more than would be expected when used individually.

When more than one nutrient is being added to fortify food and/or beverage products, a formulation scientist must consider interactions, both positive and negative, which could take place. (Also, achieving the desired level of fortification for labeling purposes becomes more complex when more ingredients are part of a food/beverage system.)

An example of this is seen with vitamin C and iron. Vitamin C has been shown to improve iron bioavailability. Other studies have indicated that iron and other trace minerals increase the rate of ascorbic acid (vitamin C) destruction. The reaction was dependent on there being sufficient moisture to facilitate the mobility of the trace mineral ions.

The presence of vitamin E has been shown to increase the bioavailability of vitamin A. One explanation of this is that tocopherol, as an antioxidant, stabilizes vitamin A in the gastrointestinal tract. Calcium has also demonstrated an inhibitory effect on iron absorption. In a solution-e.g., in a beverage application-ascorbic acid has been shown to destabilize folic acid and vitamin B12. Degradation products of vitamin B1 (thiamin) have also been shown to accelerate the rate of degradation of folic acid and vitamin B12. These observations are of practical significance in cases where solutions of water-soluble vitamins can be sprayed on foods during the fortification process (for powdered products).

Added nutrient fortification may also translate to increased manufacturing challenges due to stability of the added nutrients and interactions due to processing temperatures. Also, the addition of combinations of functional food ingredients into different delivery systems is always critical to protect the nutrient density of the finished product with respect to taste, texture, and shelf life throughout the life cycle of the finished product. However, one can easily cover up off-tasting notes by adding flavor and/or a diversity of flavors to mask undesirable flavor notes.

Because each product has a unique manufacturing process, it is impossible to plan for every possible reaction from the fortification components. Undesirable reactions can include discoloration, metallic or off-taste (i.e., bitter, sulfur notes, etc.), de-stabilization, flocculation, and sedimentation.

Another important consideration is the delivery channel, as different demographics vary in food and beverage preferences. Nutrients perform and interact differently depending on how they are integrated and in what application. Various market forms may need to be explored, depending on the end-use. Also, sensory changes caused by functional ingredients or any nutrient should be minimized at the beginning of the premix and finished-product development phase, rather than later.

Even though most products are complex, one should keeping the following simple steps in mind:

1) Try to keep it simple. Understand the physical and chemical properties of the functional ingredient, and use the correct type and amount in the formulation.

2) Be aware of the impact that processing conditions will have on your ingredients’ efficacy and bioavailability. Heat, hold time, sheer extrusion, and other unit operations can all reduce the stability of nutrients.

3) Meeting the label declarations at the end of shelf life is a must, so adjust your formulation accordingly.

4) Many nutrient ingredients are sensitive to storage conditions. Heat, light, and humidity can adversely affect them, so they need to be stored properly.

5) Care should be taken with certain ingredients with increased solubility or microencapsulation if you wish to minimize interactions or unwanted flavors, or need to protect ingredients from adverse processing effects.

The complexities of multiple ingredient fortification are no small challenge. It is important to approach fortification with a willingness to work through trial and error, a great deal of R&D to back up formulation ideas, and a solid understanding of how ingredient fortification systems work in applications.

Ingredients Targeting Cholesterol

Cardiovascular disease (CVD) encompasses a number of different disease processes that can affect the proper function of the heart and blood vessels supplying the heart and the brain. Two common potentially deadly consequences of CVD are heart attack and stroke, with almost 17 million people around the world dying each year from this malady, according to the World Health Organization. About half of heart attacks result from arrhythmias that interfere with the normal pumping action of the heart.

The other half of heart attacks can occur as a consequence of buildup of fatty deposits, called cholesterol, in the relatively small coronary arteries that supply blood to the heart muscle itself. Cholesterol is a waxy, fat-like substance made in the liver and other cells and found in certain foods, such as meat, dairy products, and eggs. The body needs some cholesterol in order to function properly. However, an acute blockage of blood flow through these narrowed vessels often occurs due to the rupture of one of these fatty deposits (called plaque) that cuts off the vital coronary artery blood flow to the heart muscle and causes a temporary lack of oxygen to the heart muscle (called ischemia), which causes acute pain and subsequently damages the heart muscle itself.

Qualified health claims permitted for dietary supplements and functional foods to support cardiovascular health that can be used on labels, with appropriate disclaimers mandated by FDA for functional foods/supplements, include:

• B vitamins and vascular disease

• Walnuts and heart disease

• Nuts and heart disease

• Omega-3 fatty acids and heart disease

There are three main types of cholesterol that are in our blood: low-density lipoprotein (LDL), high-density lipoprotein (HDL), and very-low-density lipoprotein (VLDL).

LDL Cholesterol
LDL, which is the “bad” cholesterol normally talked about, is produced by the liver and is what increases the risk of heart disease. It carries fats to all areas of the body, including the heart. According to the National Cholesterol Education Program, LDL levels between 130 and 159 mg/dL are considered borderline high.

HDL Cholesterol
HDL is considered the “good” cholesterol. It carries fats from the heart and other areas of the body back to the liver for removal. High HDL levels are an indication of a healthy heart because it means that less LDL cholesterol is in the blood and hence, less plaque formation.

VLDL Cholesterol
VLDL is formed by a combination of cholesterol and triglycerides. VLDLs are heavier than low-density lipoproteins and are also associated with atherosclerosis and heart disease.

Dietary Approaches to Lower CVD Risk
Dietary approaches to lower the risk of CVD include consuming diets lower in saturated and trans fatty acids and higher in potentially helpful heart-protecting bioactive food components, such as monounsaturated fatty acids, plant sterols, omega-3 fatty acids, dietary fiber, dietary antioxidants, folic acid, and vitamin B₁₂.

Plant Sterols
The reduction of high blood cholesterol is an important line of attack in fighting CVD and has led to the development of important drugs, such as the cholesterol-lowering statins. In addition, dietary efforts to reduce high blood cholesterol levels include lowering dietary intake of total fat and especially saturated fat and trans-fats. In addition, increased intake of various cholesterol-fighting dietary components, such as plant sterols (phytosterols), can be of help in combating hypercholesterolemia and CVD.

Sterols are an essential constituent of cell membranes in animals and plants. Cholesterol is the sterol found in human cells, while phytosterols are produced by plants. Phytosterols may help lower LDL cholesterol levels by as much as 15%, according to some studies, by competing with cholesterol in the digestive tract and blocking absorption so less cholesterol is then absorbed by the body and sent to the liver.

A health claim for plant sterols has been recognized by FDA because phytosterols have been shown to block the intestinal absorption of cholesterol, which helps lower blood cholesterol. Phytosterols were first marketed in fortified margarine and have proven to be effective in lowering blood cholesterol at doses of about 2 g per day. The development of new food formats containing plant sterols, such as bread, cereals, beverages, yogurt, and yogurt drinks, and low-fat cheese, are important to spur continued market growth in the plant sterol area.

The body manufactures about 80% of the cholesterol in serum and body tissues, with only about 20% coming from food. Everyone inherits a different body factory. Although you may eat identical diets, your neighbor can have a perfect cholesterol pattern while you have much too much bad cholesterol. LDL cholesterol and total cholesterol vary together. When LDL is high, total cholesterol is also high.

Omega-3 Fatty Acids
FDA has also approved a qualified health claim for products containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). In a study published in the American Journal of Health System Pharmacy (March 2007), patients with high triglycerides and poor coronary artery health were given 4 g/day of a combination of EPA and DHA, along with some monounsaturated fatty acids. Those patients with very unhealthy triglyceride levels (above 500 mg/dl) reduced their triglycerides on average 45% and their VLDL cholesterol by more than 50%.

In addition, there is some suggestion that DHA may also reduce blood levels of C-reactive protein, a biomarker of inflammation. The American Heart Association recommends eating 0.5 to 1.8g of EPA and DHA per day to protect against heart disease. According to Packaged Facts, sales for omega-3 containing foods were $2 billion in 2006. In 2011, retail sales of foods and beverages enriched with omega-3 fatty acids are expected to exceed $7 billion.

Dietary Fiber
Fiber can protect against coronary heart disease by lowering blood cholesterol, attenuating blood triglyceride levels, decreasing hypertension, and normalizing postprandial blood glucose levels. The consumption of dietary fiber, especially water-soluble fiber, is inversely associated with coronary heart disease risk. The National Academy of Sciences recommends a fiber intake of 38 g/day for young men and 25 g/day for young women, based on intake of 14 g of fiber per 1000 calories. Intakes of soluble viscous fiber of 5 to 10 g/day can reduce blood cholesterol. In the United States, FDA has approved two health claims for soluble fiber: one for beta-glucan soluble fiber found in oats and the second for psyllium seed husk. Consumption of nuts may also have important health benefits for the heart. The FDA has also approved a qualified health claim for walnuts. Many nuts are exceptionally rich in fiber and nutrients that may have a positive effect on heart health.

Flavonoids
Diets high in fruits and vegetables can protect against heart disease. Various phytoestrogenic compounds may be important for heart health and are found abundantly in soy, flax seed oil, whole grains, fruits, and vegetables. In addition, other bioactive flavonoids, found in fruits, vegetables, and teas, are believed to be beneficial for cardiovascular health.

In a 2007 study, Finnish researchers found that among 1400 middle-aged men, after taking into account known risk factors for heart disease, those with the lowest intake of flavonoids were at the greatest risk of heart disease. Flavonoids also contain antioxidant activity and may protect LDL cholesterol from oxidation. Popular sources of antioxidants are the “superfruits,” such as açai, mangosteen, goji, and pomegranate, as well as more readily available fruits such as blueberries and strawberries.

Policosanol
The components of policosanol include 1-octaavnuk, 1-ditriacontanul, etc. This mixture of alcohols is clinically proven to be effective in mitigating normal cholesterol levels. In vitro studies show that it is effective in lowering both total cholesterol and LDL cholesterol, and increases the levels of HDL cholesterol, along with beneficial effect of inhibiting of platelet aggregation and thereby inhibiting of platelet aggregation and thus maintaining cardiovascular health.

At a dose of 15 to 20 mg daily, policosanol has been found to lower total cholesterol by 15 to 20% and LDL cholesterol by 20 to 30%, while raising HDL cholesterol by 1 to 15%.

Vitamins
Increased consumption of antioxidant vitamins can have a beneficial effect on CVD risk by their effect on the major contributors to CVD risk, such as hypertension and diabetes mellitus, or direct effects on the molecular mediators of CVD. For example, several epidemiologic studies have found an inverse association between plasma vitamin C levels and blood pressure. This association was particularly strong among women. In addition to vitamin C, an important antioxidant vitamin is vitamin E, which in concert with vitamin C can help to reduce the risk of CVD by preventing free radical damage of LDL cholesterol

Pycnogenol
French Maritime pine bark is another form of oligomeric procyanidins (polyphenol substances in the plant kingdom) that has been shown to help relax the vasculature, enhance microcirculation by increasing capillary permeability, and cut cholesterol levels.

Curcumin
Curcumin is a polyphenol and is responsible for giving turmeric its yellow color. According to research noted in the International Journal of Vitamin Nutritional Research, curcumin reduces cholesterol by interfering with intestinal cholesterol uptake, increasing the conversion of cholesterol into bile acids, and increasing the excretion of bile acids. Several studies have reported that curcumin is beneficial in lowering LDL and raising HDL cholesterol while reducing the lipid peroxidation. Ten human volunteers were given 500 mg of curcumin for seven days during a controlled trial at Amala Cancer Research Centre in India. After seven days, researchers noted a 29% increase in good cholesterol and a reduction of 11.6% total cholesterol. Lipid peroxidation was also reduced by 33%.

In order for cholesterol-lowering ingredients to be accepted by consumers in their quest for a fortified food or beverage product that addresses this condition, manufacturers will need to clearly communicate:

• How well the ingredient works in lowering cholesterol (percentages, time span, etc.)

• The effective daily dosage

• Scientific backing on claims

FDA has approved several health claims for ingredients that support heart health:

• Soy protein: 25 g of soy protein per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease

• Food products and supplements that contain esterified or free forms of phytosterols: diets low in saturated fat and cholesterol that include at least 1.3 g of plant sterol esters or 3.4 g of plant stanol esters, consumed in two meals with other foods, may reduce the risk of heart disease.

• In 1997, oats boosted the star power of fiber with the FDA health claim, “three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease.”

• FDA also approved a qualified health claim for nuts “scientific evidence suggests, but does not prove, that eating 1.5 oz per day of most nuts such as walnuts and almonds, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.” Nuts able to make this claim, in addition to walnuts and almonds, include hazelnuts, peanuts, pecans, some pine nuts, and pistachios.