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Articles from 2009 In August


Consumers Will Pay for Convenience

NEW YORK—More than a quarter of shoppers said they would spend more money to save time in a report from marketing firms The Integer Group and M/A/R/C.

“The Checkout” report found, in June 2009, 28 percent of shoppers would pay for convenience, which is up from 23 percent in May. In addition, the amount of consumers who said they shop around to save money fell to 28 percent in June from 33 percent in May.

The monthly report, which surveyed 1,200 adults, also found that consumers are now more comfortable with using credit cards than in recent months. Twenty-six percent preferred to buy on credit instead of waiting to purchase later, up from 23 percent in May. Other criteria related to convenience, such as "is easy for me to find the things I need" and "checkout is quick" saw notable increases when compared to earlier results.

Canada May Add Acrylamide to Schedule 1

OTTOWA, CanadaHealth Canada is considering placing acrylamide onto Schedule 1 of the Canadian Environmental Protection Act, 1999 in order to minimize the publics exposure to the chemical, FoodProductionDaily.com reported.

Health Canada is proposing a three-pronged risk management approach to cut the exposure of Canadians to acrylamide, which is produced when starchy foods are cooked at high temperatures.

The approach includes pressing the food industry to develop and implement acrylamide reduction strategies for use by food processors and the food service industry; regularly updating consumption advice; and coordinating risk management efforts for acrylamide in food with key international food regulatory partners, said Canadian health officials.

Rye Breakfast More Filling

Rye bread for breakfast, especially rye bran, induces satiety before and after lunch, reports a study from the Nutrition Journal (2009 Aug 26;8(1):39).

Researchers compared the hunger-decreasing effects of rye bran, an intermediate fraction, or sifted rye flour to sifted wheat flour in 16 subjects. All breads contained the same amount of calories.

Each of the rye bread breakfasts resulted in reduced appetite during the time period before lunch (08:30-12:00) compared with the wheat bread breakfast. The feelings of fullness were also seen in the afternoon in all three of the rye bread groups. A comparison within the rye breads showed bran induced the most satiety.

High caffeine Intake May Lead to Arrhythmias

BARCELONA, SpainA new study found that high caffeine intake is related to ventricular arrhythmias.

The study assessed both adherence to the Mediterranean dietknown for its beneficial role in mortality, coronary artery disease, lipid metabolism and blood pressureand coffee and caffeine intake, and their relationship to atrial fibrillation (AF).

Interviewers investigated coffee consumption and other sources of caffeine (i.e. soda drinks, cola, chocolate, tea). Coffee consumption was specifically estimated and evaluated for type of coffee consumed (filtered or boiled), number of daily cup of espresso coffee, American coffee, decaffeinated and cappuccino. Coffee intake was divided in 4 categories: low habitual (from 1 cup/day), medium habitual (2-3 cups/day), heavy habitual (more than 3 cups/day) and non-habitual (0 cup/day).

Results showed that, although total calorie intake was similar in patients with arrhythmia and in control patients, adherence to Mediterranean Diet was significantly lower in patients that developed AF, and caffeine and coffee intake was higher.

Fruit Tattoos

WASHINGTON—Sticky labels on produce may eventually be replaced by laser “tattoo” technology, or laser etching, now being tested on grapefruit by Agricultural Research Service and University of Florida scientists.

During initial tests, a carbon dioxide laser beam was used to etch information into the first few outer cells of the fruit peel, then the laser label was covered with wax. Further testing has shown the wax may be unnecessary, since the tiny holes etched into the grapefruit peel are sealed by the carbon dioxide, preventing decay and food pathogen entry. In testing for fruit decay, the fruit was inoculated with decay organisms and then etched with the laser. No pathogens were found in the peel or the fruit interior. Wax coverage is recommended to eliminate water loss.

Testing is also being conducted on tomatoes, avocado and other citrus fruits. The process would have to be approved by the FDA before it could be used commercially.

FDA Issues Guidance on AER Labeling

WASHINGTONFDA has issued guidance on labeling of dietary supplements relative to mandatory submission of serious adverse event reports (AERs) by dietary supplement manufacturers, packers and distributors.  The guidance includes information on the contact info and language relative to serious AER submissions by consumers. However, the guidance is not a list of legal requirements, but a detailed view of the agencys current thinking on the matter.

In short, if a supplement label does not have a domestic address or phone number for consumers to report adverse events, it is considered misbranded. For an address, a full U.S. mailing address should be used, including street address or P.O. box, city, state, and zip code of the responsible person/party. Likewise, a  telephone number  fulfilling the labeling requirement should include an area code, or it is considered incomplete.

FDA contends the use of incomplete contact information would increase the likelihood either the serious AER would not reach the responsible person or the consumer would be deterred from submitting a serious AER. On the other hand, the agency states while the law on serious AERs does not call for language informing consumers the labeled address or phone number is for AER submissions, it advises companies to include such information. FDA added it sees no harm in such language including a statement that the contact information can be also used for non-AER communications.

The law for mandatory reporting of serious adverse events is already in effect, but FDA said it will exercise enforcement discretion for the new labeling requirements until Sept. 30, 2010.

[The American Herbal Products Association] AHPA is appreciative of FDAs decision to provide an extended period of enforcement discretion, and encourages member companies to promptly review labels for inclusion of a domestic phone number or address, said  Michael McGuffin, president of AHPA. At the same time, AHPA continues to have concerns about the short-cut to rulemaking expressed by FDAs signal language recommendation, and the agencys unwillingness to accept the clearly stated intent of Congress. Companies may want to consider the limits of their actual legal responsibility when determining whether to adopt FDAs recommendation for use of this signal language.

See more about the guidance, including details on how to submit comments, at the FDA Web site.

 

The Skinny on Food and Cholesterol

oatmeal

Our food mantras around fat and cholesterol have changed dramatically over the past decade. When medical professionals supported low fat, low cholesterol as the way to heart health, food scientists quickly reformulated their products. But, as Americans attempt to cut more fat and cholesterol out of the diet, waistlines keep increasing, as does the rate of heart disease. It is estimated that, in 2009, 785,000 Americans will have a new coronary attack, 470,000 will have a recurrent attack, and 195,000 will have their first heart attack (Free Radical Biology & Medicine, 2007; 43:1,374-6).

Blood lipids rising

What is causing this rise in blood lipids? The first study to make a connection between saturated fatty acid  (SFA) intake and coronary heart disease (CHD) was The Seven Countries Study. This study demonstrated that a populations intake of SFA was strongly correlated with serum cholesterol levels in the population; countries consuming more than 15% of total calories from SFA had the highest CHD mortality. SFAs elevate blood cholesterol with a dose-response between the SFA and LDL-C, with the most hypercholesterolemic SFAs being lauric (C12:0), myristic (C14:0) and palmitic (C16:0) acids.

Fat-free, low-fat, trans-fat free. After having these phrases thrown at them, no wonder its hard for consumers to swallow the new recommendations to enjoy healthy fats. But research has come a significant distance over the last decade regarding dietary fats and heart health. In 2006, the Womens Health Initiative Dietary Modification Trial, published in Journal of the American Medical Association (2006; 295(6):655-666), demonstrated virtually identical rates of heart attack, stroke and other forms of cardiovascular disease in women who followed a low-fat diet and in those women who didnt. The Nurses Health Study, which supported the same conclusions, also found that replacing 80 calories of carbohydrates with 80 calories of either polyunsaturated or monounsaturated fats lowered the risk for heart disease by about 30% to 40%, while replacing just 30 calories of carbohydrates (7 grams) every day with 30 calories of trans fats (4 grams) nearly doubled the risk for heart disease.

Consuming just 3% of daily caloric needs from trans fatty acids (TFA) will raise low-density lipoprotein (LDL) levels, and consuming 6% of daily needs from TFA will additionally lower HDL cholesterol levels. With this research, the American Heart Association, Dallas, continues to recommend total fat intakes at less than 30% of total daily calories, while the National Heart, Lung and Blood Institute, Bethesda, MD, recommends that total fat intake comprise 25% to 35% of total energy, with less than 7% coming from saturated fat.

Consuming cholesterol

As studies discovered that high cholesterol levels are associated with heart disease, health professionals began encouraging their patients to eliminate or drastically reduce their intake of dietary cholesterol. However, many studies show a weak relationship between a persons dietary intake of cholesterol and their serum cholesterol level. Most people, on average, produce more cholesterol in their body than actually absorbed from dietary cholesterol. There is, however, a small percentage of the population that does experience a strong rise and fall in their serum cholesterol in direct response to their dietary cholesterol intake. Unfortunately, there is no way to identify this population, except by trial and error. This causes health professionals to continue recommending, as a healthy precaution, that the general public limit their daily consumption of cholesterol.

Even by following a low-cholesterol diet, there are a couple groups of people who are genetically predisposed to high cholesterol. Two specific groups include those with familial dyslipidemia and familial hypercholesterolemia (also known as FH, type IIa, or high LDL cholesterol, normal triglyceride). Those with familial dyslipidemia have a combination of a high triglyceride level (in at least two family members) and low levels of high-density lipoprotein (HDL) cholesterol. Approximately 15% of patients with CHD have familial dyslipidemia. Additional risk factors in this group include android obesity, insulin resistance, type 2 diabetes and hypertension. In FH, the LDL receptors are either absent or nonfunctional, resulting in hypercholesterolemia (usually greater than 300 mg/dL). FH accounts for 2% of CHD occurring before the age of 60.

Plant sterols and stanols

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. Although they have a similar chemical makeup to cholesterol, phytosterols contain a methyl or ethyl group in the side chain that causes them to be poorly absorbed by the intestines. Sterols are naturally found in small quantities in fruits, vegetables, nuts, seeds, cereals, legumes and vegetable oils. Stanols are found in the same foods but in much smaller quantities. Over 40 plant sterols have been identified, with ß-sitosterol, stigmasterol and campesterol being the most abundant. 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. According to a statement by the Nutrition Committee of the Council on Nutrition, Physical Activity and Metabolism of the American Heart Association, few adverse effects related to either the short-term or long-term consumption of the plant stanol/sterol ester-containing fats have been reported. However, there have been observations of decreased levels of plasma Alpha-plus beta-carotene, alpha-tocopherol and/or lycopene as a result of the consumption of foods containing both stanol and sterol esters. Because of potential adverse effects on fat-soluble nutrient levelsuntil further long-term studies are performedthe committee recommends that these products should only be consumed by adults who require lowering of total and LDL cholesterol levels, or for secondary prevention after an atherosclerotic event.

Science of soy

Soy has been vastly researched for its heart-health effects. A 1995 meta-analysis of 38 studies concluded that soy protein reduced low-density lipoprotein cholesterol (LDLC) by approximately 13%, independent of the fatty-aced content of the soyfoods. In addition to a healthy diet, a daily intake of 25 grams of soy, with intact isoflavones, has been suggested to lower LDL cholesterol by 4% to 8% in hypercholesterolemic persons. More-recent meta-analyses have concluded that this figure might be closer to 3% to 5% LDL reductions, but this still could reduce risk of heart disease by up to 10%. Soy protein might also increase good high-density-lipoprotein (HDL) cholesterol by 1% to 3% and decreases triglyceride levels by 5% to 10%.

The mechanism by which soy protein reduces cholesterol has been a hot topic among investigators. Some theorize that cholesterol is lowered due to the displacement of higher-fat and higher-cholesterol foods for soy products. Some research points to peptides formed after soy protein digestion that might data suggest that regulate hepatic LDLC receptors. Other theories suggest that isoflavones in soybeans create the cholesterol-lowering effects.

Fiber effects

There are two main theories behind why fiber may help reduce cholesterol levels. First, its thought that viscous soluble fiber, beta glucans, increase bile acid excretion, which in turn increases bile acid synthesis and reduces circulating levels of cholesterol. The second theory is that the bacteria in the colon ferment the fiber to produce acetate, propionate and butyrate, which inhibits cholesterol synthesis.

Despite which theory is the reality, studies show that soluble fibers (pectins, gums, mucilages, algal polysaccharides and some hemicelluloses) in legumes, oats, fruits and psyllium lower serum cholesterol and LDL cholesterol. However, the quantity needed to achieve results differs, depending on the food source.

Rice bran fiber is an additional component that has been looked at by investigators. A study published by the American Journal of Clinical Nutrition (2005; 81(1):64-68) specifically focused on defatted rice bran vs. rice bran oil to determine the component that has lipid-lowering effects. The results showed that defatted rice bran did not lower lipid concentrations, while a rice bran oil diet decreased LDL cholesterol by 7%, leaving HDL cholesterol unchanged.

Going nuts

Although nuts do pack in the fat and calories, ranging from 10 to 22 grams of fat and 150 to 180 calories per ounce, a little goes a long way. Fortunately, the fats found in nuts are primarily unsaturated fatty acids (both monounsaturated and polyunsaturated), which have been shown to lower the risk of heart disease and reduce LDLs. A clinical trial published in the Sept. 2002 issue of Circulation (106(11):1,327-1,332) found that subjects who ate about one ounce of almonds each day lowered their LDL cholesterol by 4.4% percent from baseline.

The nuts that score highest on heart-health benefits include: walnuts, almonds, pecans, hazelnuts, pistachios, some pine nuts and peanuts. The cholesterol-lowering effect is mostly attributed to the mono- and polyunsaturated fat content, but may also be attributed to their other components, such as fiber and phytosterols, and each nuts amino-acid composition.

Cardio cocoa

Cocoa powder is extremely rich in polyphenols and has been shown to inhibit LDL oxidation. One study, published by the American Journal of Clinical Nutrition (2007; (85(3):709-717), found a significant increase in plasma HDL cholesterol (24%) when compared to the control group (5%). Participants in this study consumed cocoa powder with 26 grams of polyphenols daily for 12 consecutive weeks. Studies surrounding cocoa parallel those showing a positive correlation between the inhibition of LDL oxidation and the phenols derived from red wine.

Although we have made many strides in our understanding of food and its effect on cholesterol and heart health, no one food or food component can be the magic cure-all. Many of these foods described here work best in conjunction with each other in a well-balanced diet, and food products that effectively combine those qualities will deliver valuable cholesterol-management tools for consumers.

Christina Fitzgerald, M.S., R.D., L.D.N., specializes in pre- and postpartum, as well as pediatric, nutrition. She is the owner of the private nutrition practice, Nourished Nutrition and Wellness, based in Chicago, and can be reached at christina@nourishedliving.com.

 

FDA "Hearts" Health

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

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

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

  In 1997, oats boosted the star power of fiber with this 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 [name of specific nut], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Nuts able to make this claim include almonds, hazelnuts, peanuts, pecans, some pine nuts, pistachios and walnuts.

Solbar Awarded by AOCS

URBANA, Ill. and ASHDOD, IsraelThe American Oil Chemists Society (AOCS) awarded Solbar first place in two categories of analysis: Oilseed meal 100 percent Nitrogen (method Ba 4d-90) and Oil seed meal 100 percent Moisture in soybean samples by the AOCS Laboratory Proficiency Program and honorable mention for analytical determination of the analysis of residual oil content.

We are very pleased with this prestigious winning by AOCS, said Gary Brenner, VP marketing and development of Solbar. This award clearly demonstrates Solbars long term commitment to high-quality soy protein ingredients ensures highest safety standards. This action is part of Solbars strategy of setting the benchmark for quality and safety of ingredients and Im sure it will affect our potential customers buying decision worldwide.

Laboratory Proficiency award winners will be posted in the September issue of AOCS Membership magazine Inform and be placed on the AOCS Web site.

Unique Multi-Release Delivery Technologies

beads in capsules on green

by Mark J. Vieceli

 

For many years, multi-release products have been available in pharmaceutical and over-the-counter (OTC) products. Now, such products with various ingredients for preferred timing are beginning to make inroads into the dietary supplement category. Unique technologies have been created to deliver two or more components in one capsule to satisfy the market demands for products with co-release or targeted-release actives.

Consumers increasingly expect efficient, fast-acting products, especially for specialty product choices, such as sleep support or sports nutrition. They historically expressed a preference for capsulesin particular, liquid-filled capsulesover tablets because they believed liquids worked quicker and were more effective. Of late, consumers are showing a growing desire for combination products, drawn to the convenience and value of two or more ingredients in one package. They believe a multi-release product will be more effective because different components will be released at the best possible specific time and place in the body. They also like the enhanced efficacy of synergistic components in one format.

Liquid-filled capsules can be a key dosage form with some additional innovations in their delivery mechanisms. Technologies have been developed that offer a combination of solids and liquids. Such delivery formats can be chosen based on the best way to release an ingredient or component for maximum effectiveness. In the end, a number of ingredients can be contained in one dosage form for the ultimate in convenience, efficiency, effectiveness and value.

One new format places beads within a liquid-filled capsule. The liquid dose is designed to offer a quick release of an ingredient. The beads provide a controlled or delayed time release. The beads can be floating in liquids, or beads or powders can be contained in an inner capsule suspended in an outer liquid-filled capsule. The thickness of the beads coating can be changed so some beads dissolve as soon as the capsule ruptures, while other beads dissolve later.

Beads offer unique solutions to various scientific, technical and visual problems that arise when ingredients are suspended in oil. When some water-soluble ingredients are combined with oils, the mixture can turn into an unattractive paste. Also, oily plant extract pellets can create thick black oil. In both cases, putting these ingredients in bead form will create a product with greater appeal to the consumers eye.

Some hygroscopic extracts can cause brittleness in gelatin capsule shells. Formulating the extract into beads mitigates this problem. For sensitive ingredients that react to each other when combined, the ingredients can be separated either in the oil or different pelletsfor example, iron and vitamin C in two different pellets or iron pellets in omega-3 oil. A coated pellet also can protect the contents from stomach acid so the actives reach and are released in the upper intestine, something that might be important for sensitive enzyme families. Pellets can be formulated to help increase the absorption of insoluble or fat soluble ingredients as well.

Sometimes, the goal is to release two ingredients at different intervals. This would be important, for example, in a product intended to promote sleep. Time-release melatonin is designed to induce sleep and sustain it throughout the night. By pelletizing the melatonin in different sizes and coating thickness, it is timed to release more slowly.

Another design for multi-release products is a liquid capsule within a capsule. Like the beads in a capsule, this format can combine multiple ingredients with different dissolution profiles in a single dosage as well. The capsule-in-a-capsule form works for incompatible ingredients or ingredients that would separate if mixed together. The difference is all the ingredients are in liquid form.

One specific product category that can benefit from a capsule-in-a-capsule approach is probiotics; more specifically, this method is ideal for a combination of a prebiotic and probiotic. This paired delivery, known as synbiotic, aims to promote optimum digestive health more conveniently and effectively through the synergistic interactions of the prebiotic and probiotic. Research shows probiotics work best when combined with prebiotics, because prebiotics promote growth and activity of friendly bacteria that will feed the probiotic bacteria for greater effectiveness.

Capsule-in-a-capsule is designed for preferred time release of the active ingredients. A liquid prebiotic outer layer is released first to prepare the environment for the probiotic; the active in the inner capsule that dissolves later in the intestinal tract where the probiotic is most effective.

Another key advantage is the delivery technologys protective moisture defense system that helps keep the bacteria stable and inactive until it reaches the digestive system The design protects the probiotic inner capsule in an HPMC (hydroxypropyl methylcellulose) capsule suspended in a glycerin formula. This creates an effective barrier to moisture, which helps the probiotic remain inactive until it is ready to go to work in the body.

In addition to solving some technical and scientific issues inherent in combination products with multi-release profiles, these two delivery systems present some marketing advantages. Both designs can help products stand out on shelves because they look striking. One has beads swirling around in liquid-fill capsule, resulting in a snow-globe effect. The other has an inner capsule floating in a liquid through the transparent outer capsule for more of a high-tech impression. Marketers can further distinguish their products and create any number of looks by using various colors of beads, as well as colored and printed capsule combinations. The designs also visually reinforce the dual action of the product to the consumer. Instead of trusting the word on a package that says multi-release, consumers can see it for themselves with the beads in a capsule and a capsule-ina-capsule.

As consumers continue to ratchet up their preferences for convenient supplements that work well, support their desire for liquid formulations and offer dual action, combination products will likely rise in popularity. Delivery technologies will also expand in capabilities to accommodate the formulation and scientific realities of effectively releasing the growing number of components and their combinations.



Mark J. Vieceli is manager of marketing & business development for Capsugel, Americas Region. He identifies and evaluates future growth opportunities in the dietary supplement and pharmaceutical markets at Capsugel. Vieceli has a degree in food science from the University of Nebraska and has worked in new product development, sales and business development for more than 17 years in the food, nutrition, beverage and dietary supplement industry.

Mintel Reports on Energy Drinks

CHICAGOAmid the constant publicity about the potential danger of energy drink ingredients, Mintel Global New Products Database (GNPD) revealed the latest energy drink launches aren't getting any healthier. Despite this, the popular beverage market continues to grow with sales increasing more than 240 percent from 2004 to 2009. In the same timeframe, there has been a flood of new energy drinks to the market with new product launches up by more than 110 percent.

Analyzing the ingredients in energy drinks launched between 2004 and 2008, Mintel GNPD found caffeine in nearly all energy drinks produced. Meanwhile, taurine, the other popular, yet controversial energy-boosting ingredient, was found in more than one in four (27 percent) energy drinks in 2004, but has slightly reduced to one in five (21 percent) in 2008.

"There is a significant market right now for drinks offering a boost of energy," notes Lynn Dornblaser, Mintel global new products expert. "Although consumers say they try to eat and drink better, it appears that energy drinks is not a category in which that happens, as they continue to choose options that contain sugar, caffeine and taurine, all of which can have negative effects if consumed in excess."

Mintel found suppliers are producing some new energy drinks that boast more health-focused claims, but they are in the minority. Energy drinks showing a low-, no- or reduced-calorie claim have increased from 6 percent to 11 percent between 2004 and 2008. Within the same timeframe, energy drinks featuring a low-, no- or reduced-sugar claim have held steady at one in seven new launches. In addition, better-for-you energizers like vitamin B6 and guarana have remained flat appearing in approximately 22 percent and 12 percent of new product launches, respectively.

In 2008, Ocean Spray introduced a line of Cranergy Energy Drinks billed as "naturally energizing." This line of drinks contains real fruit juice blended with natural energizers, including five B vitamins, vitamin C and green tea extract. These new non-carbonated drinks are clinically shown to improve alertness and make people feel less tired. Bazza High-Energy Tea is another new energy-inducing beverage made from green tea and EGCG antioxidants and calls itself the "smarter high-energy alternative."

According to Dornblaser, "These new, natural energy-enhancing products could threaten to steal share from their less healthy counterparts. Often they are not sold in the energy drinks aisle, but in the juice or alternative beverage aisle, which may protect them from the unhealthy stigma some consumers associate with energy drinks."