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Branded Ingredient Guide

07/01/2005

In an environment where scientific support is critical to product success, several ingredient suppliers are investing in research behind their branded ingredients. Discover the latest findings behind several offerings in the dietary supplement and functional food categories.

GlucoTrim®

Calci-K™

BioAstin®

PomElla®

Ingredient Focus

Beyond just branded offerings, understanding the science behind the ingredients in dietary supplements is important to providing consumers efficacious formulas. Learn the basics behind probiotics and new findings about how obesity can influence lutein and zeaxanthin absorption and, therefore, eye health.

Understanding Beneficial Bacteria

Obesity Influences AMD, Carotenoid Metabolism

Natural Options for Diabetes Management

The epidemic of diabetes combines the worst of the American diet and lifestyle with some of the top causes of death in the United States. More than 18 million Americans already suffer Type II diabetes, with another 60 million facing Syndrome X. Fortunately, both conditions respond well to lifestyle changes and nutritional interventions that may reduce side effects, mitigate the changes in blood glucose and insulin levels, and keep the body healthy.


GlucoTrim®

Obesity and diabetes often go hand-in-hand, and both conditions are increasing in the United States at an alarming rate. While diabetes currently afflicts more than 18 million Americans, it is estimated 60 million Americans suffer from the metabolic syndrome, or Syndrome X, characterized by overweight, impaired glucose tolerance, increasing insulin resistance and dangerous changes in blood lipids. Fortunately, there are numerous natural compounds that may be indicated to help turn around the progression toward Type II diabetes.

One botanical well known in Southeast Asia for its impact on diabetes is Lagerstroemia speciosa L., commonly known as Crepe Myrtle. A tea from the leaves, which contain corosolic acid and tannins, has been used as a popular folk medicine in the area. Today, scientists are researching the impact of a standardized extract of L. speciosa, GlucoTrim®, supplied by Soft Gel Technologies Inc. (SGTI).

Several of these studies have been conducted at the Sarasota Memorial Hospital in Sarasota, Fla. A group of 56 Type II diabetic volunteers were recruited and screened for possible inclusion; 32 were qualified and 12 were chosen to participate in the GlucoTrim antidiabetic studies.

The research team started with a dose-dependence study using 10 of the pre-selected subjects, randomly divided into two even groups (J Ethnopharmacol, 87:115-7, 2003). Subjects received a daily oral dose for 15 days of a softgel or a two-piece hard shell capsule with 16, 32 or 48 mg GlucoTrim (standardized to 1% corosolic acid) sequentially with a 10-day washout period between doses.

Compared to the control blood glucose levels, both softgel and hard shell GlucoTrim formulations showed a dose dependence response, with a statistically significant reduction in blood glucose observed at the 48 mg/d dose in both formulations. However, subjects who received the softgel form showed a 30 percent decrease in blood glucose at the highest dose, while the hard shell form reduced blood glucose by 20 percent. In addition, the difference in blood glucose reduction at 32 and 48 mg/d between the different delivery methods was significant, showing the softgel was more effective.

An unpublished follow-up study involved the 12 pre-selected subjects given 48 mg/d of GlucoTrim in a softgel for 30 days, followed by a 45 day washout, then a 48 mg/d dosage in hard shell for 30 days, finished with another 45 day washout. Compared to control values, GlucoTrim in softgel and hard shell forms significantly reduced blood glucose levels. The softgel form was more efficacious, reducing blood glucose levels by 32 percent, compared to 23 percent during the hard shell intervention. Rebound of blood glucose during the washout periods was slow, suggesting a memory effect that could mitigate possible adverse side effects if a dose was missed.

Next, the investigators conducted a study using five of the patients to examine the rate of transport of glucose out of the blood after a meal. Blood glucose levels were monitored before and after a 30 day regimen of 48 mg/d of GlucoTrim. Administration of the supplement helped increase the blood glucose to maximum levels in two hours, and supplementation did not impact intestinal glucose absorption. After two hours, blood glucose levels returned to pre-meal levels at a faster glucose transport rate after the 30 day intervention than before, suggestion GlucoTrim supplementation could enhance glucose clearance from the blood.

Finally, the investigators selected five patients who had participated in the second study phase to examine the 24-hour blood glucose transport profile. Clearance rate of blood glucose was measured over a 24-hour period before and after being treated with 48 mg/d GlucoTrim for one month. Blood glucose levels were found to increase with each meal and return to pre-meal levels within three to six hours in the patients taking GlucoTrim. The researchers concluded GlucoTrim could help diabetics avoid food cravings associated with large swings in daily blood glucose levels.

In summary, the researchers at Sarasota Memorial Hospital found both soft-gel and hard shell delivery forms of GlucoTrim, at a dosage of 48 mg/d, could markedly lower blood sugar in Type II diabetics, with greater bioavailability exerted by the soft-gel. Further, GlucoTrim appears to help normalize blood glucose levels, glucose transport rates and clearance rates, suggesting intervention in patients in the initial stages of blood glucose intolerance (Syndrome X) could prevent further disease development.


Calci-K™

Minerals play a critical role in the prevention of many chronic diseases, including heart disease, diabetes, osteoporosis and obesity, by protecting and maintaining the body’s integrity and communication systems. The most prevalent mineral in the body is calcium, which is crucial to muscle and bone development and maintenance, blood clotting, nerve transmission and cellular membrane function. Adolescents building bone mass and women at risk of bone loss have the greatest need for calcium.

Nearly all calcium in the body is stored in the teeth and bones, with only approximately 1 percent found in the body fluids and cells. The body regulates calcium absorption through a biological control system that depends on a balance between calcium levels from bone formation and resorption (breakdown), intestinal absorption and additional excretion.

While calcium is best known for its ability to help the body develop and maintain healthy bones and teeth—playing a key role in preventing osteoporosis—it has many other important roles in the body. Calcium is involved in several steps of the blood clotting mechanism, regulates fluid passage through cell membranes, and affects the regulation of nerve impulses and muscle contractions. It has also been shown to help reduce hypertension by normalizing intracellular calcium; the magnitude of calcium’s hypotensive effect among patients with high blood pressure is comparable to that of many pharmaceuticals.

Given the range of benefits calcium poses, it is not surprising that the mineral is one of the most common found in dietary supplements and fortified foods. As more companies look to fortify their products with bioavailable calcium, manufacturers are looking for ways to mimic the effects of dairy calcium, considered the highest standard of bioavailable calcium.

Albion Advanced Nutrition recently launched Calci-K™, a calcium potassium phosphate-citrate complex. The company commissioned Robert Heaney, M.D., a professor at Creighton University’s Osteoporosis Research Center in Omaha, Neb., to conduct research on the absorbability of Calci-K, relative to milk alone and to milk fortified with Calci-K.

Eighteen adult men, ages 23 to 59, participated in the randomized, crossover trial involving three test meals in each subject, spaced two weeks apart. Subjects consumed tracer-labeled samples of Calci-K, skim milk or a combination of the two with a breakfast of buttered toast and water, tea or coffee. The labeled calcium load in all tests was 300 mg. Heaney found Calci-K, taken alone, was absorbed at approximately 76 percent of the efficiency of the same calcium ingested as milk. When Calci-K was co-ingested with milk, absorption was identical between the Calci-K plus milk and the plain milk. Heaney noted the finding was unusual because more commonly a food will reduce the absorbability of an added product.

Albion noted the Calci-K complex forms a colloidal dispersion when added to solutions with a pH between 3.5 and 8.0. No additional stabilizers are necessary to keep this calcium ingredient in solution. It is especially suitable for calcium supplementation of dairy products, imitation dairy products, soy based products, beverages, infant foods, powdered dairy products, and other foods of neutral pH. Adding 27 grams of Calci-K to a gallon of water produces a water providing 300 mg of calcium per 8-oz. serving without any palpable change in taste, odor, color or consistency. The addition of this calcium form to milk has no effect on the flavor or mouth feel of the milk product. In addition, Calci-K has demonstrated great stability in UHT (ultra-high temperature) processes.


BioAstin®

Carotenoids help bring color to nature. These fat-soluble compounds help put the red in tomatoes, the yellow in fall leaves and the pink in flamingoes. While the pink-tinted carotenoid astaxanthin has not yet achieved the wide consumer recognition of beta-carotene or lycopene, it appears to be among the most powerful antioxidant carotenoids, with the ability to help mitigate or prevent a number of chronic conditions.

Astaxanthin has a structure similar to that of betacarotene, but with two additional asymmetric carbon groups attached to the benzoid rings on either end. These R-bonds allow the astaxanthin molecule to be esterified, a unique chemical advantage among carotenoids that permits astaxanthin to span cell membranes, cross the blood-brain barrier and bond directly with muscle tissue. Natural astaxanthin’s carotenoid fraction is approximately 95 percent astaxanthin, with varying amounts of lutein, betacarotene and canthaxanthin.

One of the leading producers of natural astaxanthin is Cyanotech Corp., which operates the largest microalgae production facility in the world, including 85 culture ponds covering 45 hectares. From these ponds, the company produces its BioAstin® Natural Astaxanthin, extracted from Haematococcus pluvialis microalgae—the richest natural source of astaxanthin. BioAstin is a natural, vegetarian-sourced astaxanthin with applications in areas including inflammation, immune function, skin health and strength/endurance. However, its primary benefit appears to stem from its powerful role as an antioxidant.

Astaxanthin works to both scavenge free radicals and quench singlet oxygen. It can scavenge by incorporating the unpaired electron into its own molecule or by donating an electron to stabilize the free radical. In quenching singlet oxygen, astaxanthin de-charges the excited oxygen molecule, rendering it harmless. The in vitro oxygen free radical scavenging ability of BioAstin was found in studies at Creighton University to be 550 times stronger than vitamin E and 11 times more powerful than beta-carotene. In addition, human and animal toxicology trials have established astaxanthin cannot be turned into a “pro-oxidant” as seen in some studies using beta-carotene; according to these trials, astaxanthin’s unique esterified benzoid rings prevent the formation of pro-oxidant forms.1

Astaxanthin’s ability to prevent oxidative damage is integrally linked to its antiinflammatory ability. A rat study showed astaxanthin was able to inhibit carrageenan-induced inflammation and edema caused by reactive oxygen through antioxidative action.2 This anti-inflammatory antioxidant activity is coupled with its ability to address production of inflammatory factors such as nitric oxide, cyclooxygenase (COX)-2 and prostaglandin E2. Korean researchers reported astaxanthin worked to suppress production of pro-inflammatory mediators and cytokines in macrophages and cells activated with lipopolysaccharides.3 These anti-inflammatory abilities suggest astaxanthin may help manage acute and chronic inflammatory conditions, such as repetitive stress injury, arthritis, sunburn and exercise-induced muscle damage.

Human clinical trials have tested the efficacy of BioAstin in the relief of pain and the improvement of performance in patients with carpal tunnel syndrome (CTS) and rheumatoid arthritis (RA). In a double blind, placebo-controlled study of 20 adults suffering CTS, administration of BioAstin gelcaps (12 mg/d astaxanthin) reduced the rate and duration of pain.4 Similar results were reported by the same researchers in a study of 21 RA patients, who reported administration of 12 mg/d astaxanthin (as BioAstin gelcaps) reduced pain and increased treatment satisfaction measures.5 These clinical trials were initiated after individuals suffering from CTS reported receiving relief from their symptoms after including BioAstin supplements in their diet.6 Cyanotech currently holds a U.S. patent on astaxanthin for use in carpal tunnel or repetitive stress injury.

The company also holds a U.S. patent on the use of astaxanthin as an oral and topical sunscreen. An unpublished study, sponsored by Cyanotech, found people who consumed BioAstin gelcaps (4 mg/d astaxanthin) showed a significantly reduced sensitivity to sunburn after only two weeks. The researchers reported the effective amount of astaxanthin was 10 times lower than that of beta-carotene or lycopene.

Astaxanthin also shows promise in the area of sports recovery, as its antioxidant and anti-inflammatory properties may beneficially affect muscle. A Swedish study involved administration of natural astaxanthin or a placebo to 40 healthy young men to study impact on muscle endurance. After six months of supplementation, the men receiving astaxanthin showed a significant improvement in muscle strength and endurance compared to the control group.

Another placebo-controlled study, which involved 20 weight-trained males, assessed the affect of BioAstin supplementation (2 mg/d) on delayed onset muscle soreness (DOMS).7 After a three-week supplementation period, subjects conducted a vigorous exercise session designed to induce DOMS. While there were no clear improvements with BioAstin supplementation, there were also no health-related problems associated with the product.

BioAstin is processed under GMP (good manufacturing practices) in an ISO 9002 certified quality management system; Cyanotech holds a patent on its oxygen-free drying method (Ocean-Chill drying), which eliminates oxidative losses. The dried microalgae is purified and extracted using a supercritical CO2 process that ensures there are no extraction residues in the final product. The astaxanthin levels in the product are determined with a validated HPLC methodology. BioAstin was approved as a new dietary ingredient (NDI) by the U.S. Food and Drug Administration (FDA) in August 1999, and is available from Cyanotech in softgels and in stabilized tablet beads.

References

1. Beutner S et al. J Sci Food Agric. 81:559-68, 2001.

2. Kurashige M et al. Physiol Chem Phys Med. 22:27-38, 1990.

3. Lee SJ et al. Mol Cells. 16, 1:97-105, 2003.

4. Nir Y, Spiller G, Multz C. J Am Coll Nutr. 21:489, 2002.

5. Nir Y, Spiller G, Multz C. J Am Coll Nutr. 21:490, 2002.

6. Lorenz RT, Cysewski GR. Trends Biotechnol. 18, 4:160-7, 2000.

7. Fry AC et al. Presented at the American College of Sports Medicine meeting, May 2004.


PomElla®

Pomegranate has been widely used in traditional medicine to promote an array of health benefits, including reduction of inflammation and oxidative stress. Recent scientific research has connected increased inflammation with common health problems and serious conditions including heart disease, cancer and diabetes. Today, pomegranate juice and extracts are increasingly popular products in the nutritional market for their health benefits.

PomElla® is a patent-pending pomegranate extract from Geni Herbs, formulated to deliver a proprietary blend of polyphenols including ellagitannins, gallotannins and anthocyanins. The product is standardized to punicalagins, the parent compound of ellagic acid, which are found in abundance only in pomegranate. The body hydrolyzes punicalagins to ellagic acids and other polyphenols as needed, according to data presented at the American Chemical Society national meeting in 2004. Bioavailability studies suggest greater than 95 percent of punicalagin is absorbed and converted to metabolites (Eur J Nutr, 42:18, 2003), compared to greatly reduced absorption rates for oral ellagic acid (J Chromatogr Bull, 796:189, 2003).

A presentation by Navindra Seeram, Ph.D., at SupplySide East 2005 focused on both the bioavailability of pomegranate’s hydrolysable tannins and their impact on the activity of the inflammatory enzyme cyclooxygenase-2 (COX-2). Seeram reviewed different in vitro bioassays that showed punicalagins had better radical scavenging ability compared to pomegranate juice (PJ) or total pomegranate tannins (TPT). He also referenced a study showing the ability of PJ, TPT and punicalagins to decrease COX-2 expression as well as the activation of NFkappaB, a transcription factor that is overexpressed in cell cancer lines; straight ellagic acid did not show an impact on NFkappaB activation.

In April 2005, researchers from the University of Scranton, Pa., released the results of a study investigating the antioxidant behavior of PomElla in relation to that of vitamin E or straight ellagic acid. Researchers measured the decrease of copper-catalyzed oxidation of low density lipoprotein (LDL) and very low density lipoprotein (VLDL) cholesterol isolated from human plasma by the different antioxidants. The concentration required for inhibition of half the oxidation was fivefold less for PomElla than for vitamin E or ellagic acid. Coupled with additional research findings, scientists suggest the synergism among the compounds found in PomElla may offer a higher level of antioxidant benefit.

Human clinicals examining the cardiovascular effects of PomElla are underway, with results expected by the end of 2005.

 


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