Building a better cardio product

A comprehensive cardio-health functional food, beverage or supplement should contain nutritional ingredients that target a combination of symptoms—cholesterol, blood pressure, arterial health and more. Functional Ingredient’s Todd Runestad gets a beat on what's available to ensure your next product contains all it should.

The cardiovascular system is the body's red river, a veritable waterway of blood that is ferried by arteries and veins from its pumping station, the heart, throughout the body, delivering oxygen and nutrients to cells and transporting waste away. We are interested in maintaining a healthy cardiovascular system not least because it is the top reason we die — more than one of every three of us die from heart disease.

As they say, crisis equals opportunity, and the cardio-health market is ripe for the nutrition market providing solutions to help maintain and regulate a healthy system — keeping triglycerides, blood pressure and cholesterol levels in check as well as improving arterial health.

Nutrients can help address all of these symptoms. Whether you are thinking of launching a new product in this area — or refurbishing an old one by adding that 'new and improved' ingredient — there is much science to validate the nutritional approach. This fact has not been lost on marketers — 134 new food and beverage products targeting cardiovascular health were launched in the United States between January 1 and September 23 of 2008, according to Mintel's Global New Products Database.

The easy target is cholesterol levels, in particular keeping LDL cholesterol levels low (keeping HDL levels high is another good target, though more elusive to remedy). Doctors routinely counsel patients to keep cholesterol levels below 200mg/dL.

The inconvenient truth is that about an equal number of people die from cardio events with cholesterol below 200 as above. A Harvard physician, in a 2007 Lancet paper titled 'Are Lipid-Lowering Guidelines Evidence-Based?' described how no studies have shown statin cholesterol-lowering drugs to be effective for women at any age, nor for men 69 years of age or older, who do not already have heart disease or diabetes.1 Indeed, studies show between 45 and 60 per cent of patients hospitalised for a heart attack have a 'normal level' of cholesterol.2,3

So, if cholesterol won't necessarily give you a heart attack, what will? A 2007 study at the Cooper Clinic in Texas suggests the answer may be calcium. After controlling for age, gender, blood lipids, diabetes, tobacco use, hypertension and family history of premature heart disease among 303 patients, those with a coronary artery calcium score of less than 10 had only 1.7 per cent likelihood of having ischemia, or decreased arterial blood flow. For those with higher levels of calcium, the likelihood was 20 per cent — a greater than ten-fold difference.4

Some studies show that coronary calcium content is a good predictor of future coronary events in both symptomatic and asymptomatic populations.5,6,7 These studies indicate that abundant mature coronary plaque is at least a risk factor for clinical events and, possibly, is a cause of those events. But other studies show that some patients with acute coronary syndromes have little or no coronary calcium.8,9,10

So, controversy remains about whether calcium in plaque is a marker of stability or instability. When plaque is unstable, it is thought to lead to heart attack and stroke, respectively.

K2 summiting

If calcium-rich plaque deposits are indeed the harbinger of doom, one answer is surely vitamin K2, in particular the long-chain menaquinones. Only relatively recently has vitamin K2's role been delineated as being able to activate proteins responsible for calcium utilisation in bones. And just in the last few years has it been discovered that K2 activates matrix GLA protein, a prime inhibitor of vascular calcification. The upshot is a blockbuster nutrient that removes calcium from arteries, where it is not needed, and places calcium in bones, where it is.

Groups with the highest amounts of vitamin K from dietary sources such as spinach and broccoli exhibit more than a 50 per cent reduction in coronary heart disease mortality and aortic calcium scores.11

In a recent animal study, K2 supplementation reduced accumulated arterial calcium deposits, which was accompanied by enhanced arterial elasticity.12 (For its part and not to be overlooked as another wonder nutrient, vitamin D has also been shown to be correlated with the absence of extensive arterial calcification.13)

In human models, 45mcg/day vitamin K2 is seen as an efficacious dose. Once available only as a supplemental ingredient, K2 became available for the food market earlier this year.

Omega-3s fish oils

If you just can't live without a little calcium in your arteries, fish oils have the benefit of easing the stickiness of blood platelets.14 This makes the blood slide more smoothly past plaque deposits so that a chunk of plaque is less likely to break off and cause a sudden-death heart attack. A recent meta-analysis of omega-3 trials shows fish oils reduce coronary heart disease mortality by 36 per cent and total deaths by 17 per cent.15

When it comes to heart health, fish oils target a vast array of aspects. Epidemiologic and clinical trials have shown that omega-3 fatty acids reduce cardiovascular disease incidence.16,17 Large-scale epidemiologic studies suggest that people at risk for coronary heart disease benefit from consuming omega-3 fatty acids from plants and marine sources.18 They can also prevent arteriosclerosis by inhibiting the development of plaque and blood clots that can clog arteries.19 They can decrease risk of arrhythmias, which can lead to sudden cardiac death; decrease triglyceride levels; decrease growth rate of atherosclerotic plaque;20,21,22 and reduce blood pressure in individuals with hypertension.23 They're one of the few nutrients that can raise HDL cholesterol. Some studies show they can also raise LDL cholesterol, but the relative trade-off with HDL-raising means an overall net cholesterol benefit.24

The ideal amount to take isn't clear. There is as yet no official recommended daily intake amount, though industry groups are pushing for that. The success of any effort could displease non-EPA/DHA forms of omega-3s, which would presumably be left out in the cold because the FDA's qualified health claim is exclusively for EPA/DHA — other omega-3 forms skate into the market using nutrient content claims for 'omega-3s' in general. Evidence from prospective secondary prevention studies suggests that taking EPA plus DHA ranging from 0.5 to 1.8g/day significantly reduces deaths from heart disease and all causes.25 For alpha-linolenic acid (from flax and other sources), a total intake of 1.5 to 3g/day seems beneficial.26 Even the staid American Heart Association (AHA) recommends healthy people consume about 1g/day EPA plus DHA. For those who need to lower triglycerides, the AHA recommends 2 to 4g/day EPA plus DHA.

The beauty of omega-3s (in particular EPA and DHA) from a marketer's perspective is that, while according to the FDA their benefit as of now is only related to heart health, the research is amassing demonstrating benefit for just about everything from ADHD to diabetes.27,28 Truly, fish oils are the Swiss Army Knife ingredient.

Addressing cholesterol

The power of allopathic medical doctors in Western societies telling patients that heart disease is all about keeping cholesterol levels lower than 200mg/dL is difficult to trump, so despite the evidence presented earlier we'll go with the flow and pretend to want to keep cholesterol levels in check.

Niacin is the king of lowering cholesterol. Like many natural bioactives, it lowers LDL cholesterol. What sets niacin apart from the competition is that it also increases HDL cholesterol.29 Indeed, compared even to statin drugs, niacin comes out on top as statins are effective in only lowering LDL cholesterol. Niacin, on the other hand, is the most potent compound available for lowering plasma levels of triglycerides and raising HDL levels.30 Even the pharmaceutical industry advocates taking niacin concurrently with statins.31 To be sure, therapeutic doses of niacin range between 1,000 and 1,500mg/day whereas the recommended daily allowance is 14 to 16mg/day and food-product developers are hard-pressed to put into products any more than that.

Sterols are derived from natural vegetable oils such as corn and soy. Sterols and stanols have an FDA health claim to lower cholesterol levels by reducing cholesterol absorption at dosage levels of 0.8g/day. Although they have been seen to be particularly effective when incorporated into fat matrices, phytosterols have been combined with other beneficial dietary components including fish and olive oils, psyllium, and beta-glucan to enhance their effect on risk factors of cardiovascular disease.32

Studies show that 1.3g/day of plant sterol esters or 3.4g/day of plant stanol esters in the diet are needed to show a significant, 10 per cent, cholesterol-lowering effect. In order to qualify for this health claim, a food must contain at least 0.65g of plant sterol esters per serving or at least 1.7g of plant stanol esters per serving.

Sterols' effects are enhanced with diet or drug interventions: eating foods low in saturated fat and cholesterol and high in stanols or sterols can reduce LDL by 20 per cent, and adding sterols to statin drugs is more effective than doubling the statin drugs.33 The claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods.

Red-yeast rice molecules are biodentical to statin drugs, making them effective, scientifically, in lowering LDL cholesterol levels.34 But they don't work at all effectively at lowering LDL cholesterol levels from a regulatory standpoint. This is because the drug arrived on the market first and any subsequent supplement is out in the cold.

The upshot is that products containing red-yeast rice cannot suggest in any way that the product is useful for heart health. Now, for supplements at least, the answer seems to be that savvy retailers know the score and shelve red-yeast rice products in their cardio-health section (wink, wink). Some products contain only red-yeast rice, while others make it easier for consumers by combining it with other ingredients perceived to be heart healthy, such as fish oils. Again, you might consider formulating a quality combination product with ingredients that target various markers of cardio health. Indeed, a recent Mayo Clinic randomized 12-week trial found a combination of red-yeast rice and fish oils were just as effective as statin drugs for lowering LDL cholesterol.35

Soy is the poster child for the market benefits an ingredient can have once it receives an FDA-minted health claim. Lately, however, soy's fortunes have fallen as its efficacy in lowering cholesterol levels has come into question. This arose from an October 2008 meta-analysis that found an average of 70mg/day of soy isoflavones had no effect on cholesterol levels in postmenopausal women.36 If nothing else, soy consumption improves blood lipids because soy replaces the harmful fats that would otherwise be consumed in red meat — sort of subtraction by replacing.

Speaking of replacing, an interesting randomised, crossover clinical trial was undertaken with 42 postmenopausal women with metabolic syndrome. Participants consumed either a control diet (the Dietary Approaches to Stop Hypertension, DASH), a soy-protein diet, or a soy-nut diet, each for eight weeks. Red meat in the DASH period was replaced by either soy protein or soy nuts. The soy-nut regimen decreased LDL cholesterol more than did the soy-protein period (-5 per cent compared to -0.6 per cent).37 This study showcases interesting formulation possibilities by combining soy with other heart-healthy foods — nuts in this case, and walnuts and pecans both have health claims. [See sidebar for more on health claims.]

Blood pressure and beyond

Coenzyme Q-10 is one of those ingredients that ought to be prescribed every time a physician writes a scrip for statin drugs, which deplete the heart of the nutrient. (Probiotics with antibiotic prescriptions is another obvious example.) Co-Q10 powers mitochondria, the cell's power plant, and it accumulates in particular in the heart muscle. What's more, it can lower blood pressure. In a six-month, placebo-controlled trial with 74 diabetic patients, 200mg/day of co-Q10 lowered 24-hour blood pressure.38 A similar human trial, this one for 12 weeks, with 74 diabetics found 200mg/day of co-Q10 improved blood pressure and long-term glycaemic control.39

Dairy makes a prime functional-ingredient delivery system for all manner of health benefits. Milk proteins, peptides, probiotic lactic-acid bacteria, calcium and other minerals can significantly reduce blood pressure. Fermented dairy products and probiotic bacteria decrease the absorption of cholesterol.40 A year-long 2008 human study investigating whether a glycomacropeptide (GMP)-enriched whey supplement could promote satiety and weight loss more than skim milk found no significant difference on weight loss. However, researchers did discover the whey led to decreases in total and LDL cholesterol, triacylglycerols, glucose, insulin, and systolic and diastolic blood pressure after both six and 12 months, as well as increases in HDL cholesterol at 12 months.41

Whole grains are marketed to great benefit in cereals and breads. In the Nurse's Health Study, those who had a median intake of 2.7 servings of whole grains a day experienced half the risk of ischemic stroke and a 30 per cent risk reduction of coronary artery disease.42 Another study found those with the highest fibre intake had the lowest diastolic blood pressure.43 Cereal manufacturers have clearly capitalised on this data — sometimes to a questionable degree. After all, can chocolate-frosted sugar bombs with whole grains really be good for heart health?

OPCs (oligomeric procyandins) are some of the most abundant polyphenolic substances in the plant kingdom. OPCs such as grape-seed extract and crataegus also house vasodilatory and blood pressure-modulating effects.

Pycnogenol, the French maritime pine bark (Pinus maritime), is another form of OPC that has been shown to help relax the vasculature, enhance microcirculation by increasing capillary permeability, and cut cholesterol levels.44,45

Sodium is finally being fingered by regulators as the insidious agent causing high blood pressure. Formulators are quick on the draw, developing low-sodium soups (probably the worst food culprit) and other products. A February 2009 study confirmed sodium raises blood pressure. In the two-week study of 29 overweight, normotensive subjects, the dieters consuming one third the sodium had significantly lower systolic blood pressures of 112mm Hg, compared with 117mm Hg. They also scored 4.89 per cent compared to 3.37 per cent in flow-mediated dilation scores, a marker of vascular relaxation.46

Product Content


Natural channel

Fish oil concentrate

$53 million

Coenzyme Q10

$22.6 million

Coenzyme Q10

$22.6 million

Vitamin E (not Ester-E)

$9.6 million


$8.4 million


$6.4 million

Mass grocers

Fish oil concentrate

$199.8 million


$114.7 million

Plant sterols—other

$97.9 million

Coenzyme Q10

$91.2 million

Vitamin E (not Ester-E)

$68 million

Claiming health on the label

Selling healthiness is a more valuable sell than the ol' cheap-calories-in-a-packaged-food-box play. FDA-minted health claims can give your product a leg up on general wellness claims — or do they? While classic claims for potassium or sterols are straightforward sells, the brave new world of qualified health claims in some cases can be more trouble than they're worth.

For example, say you've a product with corn oil in it and would like to beef up its consumer appeal with a qualified health claim, which gives consumers additional information but with appropriate disclaimers. These disclaimers were clearly written by regulators and not marketers! Here's what you would have to print on the label to sell its healthiness:

"Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil."

Marketers: Do you think this would be effective? Something about "very limited" and "little scientific evidence supporting this claim" takes all the air out of that balloon.

Below is one example of FDA's health claims and qualified health claims available for label copy touting cardiovascular health benefits. Notice how much cleaner the straight-up health claims are than the bulkier qualified ones.

Heart health claims

  • Potassium: "Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke."
  • Sodium and hypertension: "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."
  • Sat fats: "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease."
  • Sterols: "Foods containing at least 0.65 grams per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies [x] grams of plant sterol esters."
  • Soluble fibre: "Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors." (For fruits, vegetables and grain products containing fibre, at least 0.6g soluble fibre is required per serving size without fortification. Whole oats need to contain at least 0.75g whole oat soluble fibre per serving; psyllium seed husk needs at least 1.7g psyllium husk soluble fibre per serving. Eligible sources of soluble fibre: Beta-glucan soluble fibre from oat bran, oatmeal and whole oat flour. Oat bran must provide at least 5.5% beta-glucan soluble fibre, oatmeal must provide at least 4% beta-glucan soluble fibre, and whole oat flour must provide at least 4% beta-glucan soluble fibre or psyllium husk with purity of no less than 95%.)
  • "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides [x] grams of soy protein." (To qualify for the claim foods must contain, per serving, 6.25 grams of soy protein; less than 3g fat; less than 1g saturated fat; less than 20mg cholesterol; and sodium value of less than 480mg for individual foods, less than 720mg if considered a main dish, and less than 960mg if considered a meal. Foods made with the whole soybean, such as tofu, may qualify for the claim if they have no fat other than that naturally present in the whole bean.)

Qualified heart-health claims:

  • "Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content."
  • "Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts, such as pecans, as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. (See nutrition information for fat content.)"
  • "Limited and not conclusive scientific evidence suggests that eating about 1 1/2 tablespoons (19 grams) of canola oil daily may reduce the risk of coronary heart disease due to the unsaturated fat content in canola oil. To achieve this possible benefit, canola oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of canola oil."
  • "Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product [Name of food] contains [x] grams of olive oil."
  • "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]"
  • As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6 and vitamin B12 may reduce the risk of vascular disease.*

*FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.


Health claims:

Qualified health claims:

Select suppliers: Broad array of ingredients targets cardiovascular health

Aker Biomarine
Superba krill oil is loaded with bonus phospholipids and astaxanthin.

Oil-division line includes speciality marine oils and natural vegetable oils.

Supplies a full range of EFAs from plant and marine sources from salmon to borage.

Supplies Corowise brand plant sterols.

For a web exclusive on the latest in vitamin-E research, click here.

Vegapure natural plant sterols and sterol esters. Covitol is natural vitamin E d-alpha- tocopherol concentrate.

Incromega marine lipid concentrates, high-potency EPA and Crossentials plant lipid concentrates include Incromega V3 vegetarian-source omega-3 from echium oil.

MenaQ7 vitamin K2 for food and beverage applications.

GAT 100 is a liquid fish oil for a broad range of food and beverage applications.

CardiaBeat is a conjugated matrix of sterol-omega-3 that offers multiple actions for cardio conditions. It won the NutrAward in 2007.

EPAX 6000 TG omega-3 concentrate has 300mg/g EPA and 200mg/g DHA.

Vitamk7 is vitamin K2 as menaquinone-7, and Biokyn is a natural nattokinase.

KanekaQ10 fermented, all-natural co-Q10.

Lipid Nutrition
Marinol is a shelf-stable fish-oil and powder concentrate for functional foods.

The Carnipure brand carnitine comes in four forms; the company also offers niacin.

Marcosanol brand policosanol is for lowering cholesterol.

life'sDHA is fish-free DHA for infant nutrition, foods, beverages and supplements.

Natraceutical Group
Viscofiber is a high-viscosity oat and barley concentrate.

Sensoril from ashwagandha is available in a water-soluble version for foods and drinks.

Natural Health Science
Pycnogenol is for supplements and cosmetic applications.

Neptune Technologies
NKO is Neptune krill oil, phospholipids-rich omega-3 EPA/DHA oil.

Stabilised rice bran contributes fibre with protein and other phytonutrients.

Ocean Nutrition Canada
meg-3 brand omega-3 EPA/DHA has patented Powder-loc micro-encapsulation.

Omega Pure
OmegaPure refined fish oil from menhaden is GRAS and kosher.

PL Thomas
MenaQ7 natural vitamin K2 for supplements is safe and effective at 45mcg daily dose.

MegaNatural Gold grape polyphenols

Proprietary Nutritionals
Sytrinol is derived from citrus bioflavonoids and palm tocotrienols that cut cholesterol.

T-Phenol is green-tea extract; co-Q10; and Gravinol is a grape-seed extract.

Company holds more than 100 US patents for soy technology.

Company provides soy-protein concentrates, isolates and isoflavones.

Source One Global Partners
Cholesstrinol proprietary heart-health formulas include CoQsource Bio-Enhanced Q10, OmegaChoice Concentrated Marine Omega-3s, PMF-source and Citrus Flavonoids, TocoSource Palm Tocotrienols, Cardio E Naturally Balanced E-isomers, SterolSource Phytosterols, and OPC-source French Maritime Pine Bark Extract. The formulas have benefits for triglycerides, anti-inflammatory, blood pressure, LDL and have anti-inflammatory and antioxidant properties.

Q-Gel bioavailable brand co-Q10. Derma Q-Gel is for cosmetic applications.

This 2008 Frost & Sullivan Emerging Company of the Year markets co-Q10, vitamin E and more.


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