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BAYWOOD RESEARCH MODULE RELIABLE I N F O R M AT I O N FOR INFORMED DECISIONS IN THIS MODULE: The Nature of Lipids How Lipids are Digested in Our Bodies What is Fat Eliminator™? The Fat Eliminator™ Bonus Pack Clinical Studies Quality Control RELATED MODULES: Carb Eliminator™ A Natural Dietary Supplement that Blocks the Absorption of Starch Have Questions or Comments? We appreciate every letter sent to Baywood. Comments can be directed to: Consumer Services, Baywood International, Inc., 14950 North 83rd Place, Suite 1, Scottsdale AZ: (888) 350-0799. Check out Baywood’s Website: www.bywd.com A Natural Dietary Supplement for blocking the Absorption of Dietary Fats. THE NATURE OF LIPIDS L ipids (fats) are a heterogeneous group of waterinsoluble organic molecules. Because of their insolubility in water, their transportation in plasma requires association with protein as lipoprotein particles. Lipids are not only a major source of energy for the body, but also provide the hydrophobic barrier that permits portioning of the water contents of cells and surrounding structures. In addition, lipids are responsible for many body functions. As an example, some fatsoluble vitamins have regulatory functions, and prostaglandins and steroid hormones play major roles in the control of the body’s function. Not surprisingly, deciencies or imbalances of lipid metabolism can lead to some major clinical problems. Rev/April 2002 1 BAYWOOD RESEARCH MODULE An average adult in the United States ingests about 60 to 150 grams of lipids per day. Over 90% of dietary lipids are normally triacylglycerol. The rest of them are made up of cholesterol, cholesteryl esters, phospholipids and free fatty acids. How Lipids are Digested in Our Body The digestion of lipids begins in the stomach, and an acidstable enzyme called lipase catalyzes it. Most of those enzymes originate from the small glands located at the back of the tongue. This enzyme is accessible only to those lipids located on the surface and speeds up the process of fat digestion which is still very slow at this point since lipids are not yet emulsied. Triacylglycerol molecules containing fatty acids of the short or medium length, such as those found in milk, can only be broken down by a separate enzyme called gastric lipase. This enzyme is active only at a neutral pH level and is of little use in an acidic environment of an adult stomach where pH is very low. However, in infants, whole stomach pH is close to neutral and gastric lipase is very active making milk and its lipids present an essential role in infant nutrition. In adults, the lipids we consume during the digestion are not changed to any extent in the mouth or the stomach, but they progress more or less unchanged to the small intestine where their digestion starts. The dietary triacylglycerol, cholesteryl esters and phospholipids are enzymically degraded by pancreatic enzymes whose secretion is hormonally controlled. As the name suggests, pancreatic enzymes are secreted by the pancreas in the pancreatic juice into the small intestine. The hormone, cholecystokinin, is released in the presence of lipids and proteins in the upper small intestine. This hormone acts on the gallbladder causing it to contract, releasing bile into the intestine. It also decreases stomach action, resulting in slower digestion, allowing lipids to spend more time in the stomach. Another small peptide hormone called secretin causes the pancreas to release more bicarbonates which helps neutralize low pH of the food content that just arrived from the acidic stomach, allowing pancreatic enzymes to function better. TODAY, more than a million people worldwide use chitosan dietary supplements. LipoSan ULTRA ™ is a natural, safe and effective supplement that has been shown to significantly reduce the absorption of dietary fats. In the duodenum, the critical process of emulsication of the dietary lipids occur. Since these compounds are insoluble in water, the chemical reactions needed to digest the lipids can occur only in the surface of the lipid droplets or at the border of food and surrounding water based environment of the digestive tract. The process of emulsication increases the surface area of the lipid in foods allowing enzymes to access more lipids and to act more effectively. Molecules of triacylglycerols are too large to be taken up efciently by the cells in the intestinal walls. Therefore they need to be broken down into smaller particles before being absorbed. After pancreatic lipase comes in contact with the molecule of triacylglycerol, it begins a chemical reaction that will remove two of the three fatty acids from the molecule. Cholesteryl esters are degraded by a different enzyme producing cholesterol plus free fatty acids. Emulsication is an essential part of digestion and is assisted by bile salts and mechanical mixing due to peristalsis, a movement of the digestive tract. Emulsication is a process similar to saponication where smaller droplets of fat are formed making them more accessible to enzymes for easier digestion. Free fatty acids, free cholesterol and 2-monoacylglycerol, are the primary products of dietary lipid degradation in the upper intestines. These, together with bile salts form small clusters of lipids that approach the primary site of lipid absorption, the membrane of the intestinal mucosal cells. There the lipids pass the membrane and are absorbed into the cells. Bile salts are made from cholesterol in the human liver. Since their production is constant, they are continuously being released from the liver into the gallbladder where they are stored until the food that consists of fat enters the upper portion of the small intestine. In individuals whose gallbladder has been surgically removed, bile salts travel directly from the liver to the upper small intestine. Such release is no longer controlled by the amount of food and, therefore, those individuals have altered fat metabolism. In the mucosal cells of the intestines, fatty acids are converted back into their active form and newly synthesized triacylglycerols and cholesteryl esters are formed and packed as lipid droplets, surrounded by a layer of protein into small particles called chylomicrons which travel from the lymphatic system into veins and to the blood. Chylomicrons are needed to transport lipids to skeletal muscles and fat tissue for further storage, and also to the heart, lung, kidneys and liver, where they are utilized, or in fat cells where they are stored to be used when the body needs more energy. Any deviation in this process can cause lipid malabsorption, resulting in loss of lipids including the fat-soluble vitamins A, D, E and K. Rev/April 2002 2 BAYWOOD RESEARCH MODULE What is Fat Eliminator™ Fat Eliminator™ contains a unique blend of LipoSanULTRA™ and Vitamin C. Both of those ingredients have a unique purpose in the absorption of dietary fats. The basic ingredient of LipoSanULTRA™ is raw chitin or chitosan. Chitosan is a natural biopolymer that is harvested from the shrimp shell, crabs and lobster. Since during the process of extraction most of the proteins are removed, it is still possible that some proteins are left intact. Therefore, persons with known allergies to shellsh should consult their primary care physicians before using this or any other products that contain chitosan. In addition to this specially produced chitosan, LipoSanULTRA™ also contains 5% to 10% succinic acid, which is a food additive. This organic acid allows improvement in the solubility of LipoSanULTRA™ in stomach acid which is an important factor in the stomach portion of lipid digestion. Laboratory data shows that LipoSanULTRA™ rapidly dissolves in approximately one (1) minute, which allows more time needed for chitosan to begin binding to fat. Unlike regular chitosan that requires over one (1) hour to fully dissolve, LipoSanULTRA™ can be conveniently consumed immediately prior to the meal since it will be fully functional in such a short time. In order for LipoSanULTRA™ to complex fat in the stomach, it must rst be in a solution. Regular chitosan dissolves very slowly, under minimal agitation that occurs in the stomach. LipoSanULTRA™ has been shown in scientic literature to have potent lipid binding characteristics by mediating fat entrapments that prevent fat absorption into the bloodstream. LipoSanULTRA™ is available in the stomach to complex or emulsify dietary fat during the course of digestion. When the contacts move to the upper small intestine, the acid conditions are neutralized and the emulsion of LipoSanULTRA™ and fat forms a gel. That gel traps the fat, protecting it from enzymes which prevents fats from being absorbed by mucosal cells of the intestine. Laboratory data shows that one (1) gram of LipoSanULTRA™ is able to prevent the absorption of up to twenty seven (27) grams of dietary lipids, in comparison to six (6) to eight (8) grams of fat for regular chitosan. The Fat Eliminator™ Bonus Pack Given the unique fat blocking characteristics of Fat Eliminator™, it is recommended against using the product before every meal, every day. For proper maintenance of essential fatty acids (EFA’s) in the diet, individuals taking this product may wish to consider additional supplements of vitamin A, D, E, and K. Regular use of Fat Eliminator™ should ideally be combined with a high-quality EFA such as Baywood’s Entrox®‚ and a multivitamin containing adequate amounts of fat soluble vitamins such as Baywood Complete™ multi-vitamin. Take these supplements at a different time from when you take Fat Eliminator™. To help the consumer, Baywood offers the Fat Eliminator™ Bonus Pack which combines one bottle of 120 Count Fat Eliminator™ with one bottle of 30 Count Baywood Complete™ multi-vitamin. Time Dependent Oil Binding Comparison of Various Chitosans 100 CHART SUMMARY 90 GRAMS OIL BOUND PER GRAM CHITOSAN 80 Vanson LipoSanULTRA™ 70 High Viscosity Chitosan 60 Medium Viscosity Citosan 50 Low Viscosity Citosan 40 Chinese High Desity Chitosan 30 1. Vanson LipoSanULTRA™ binds significantly more oil following 1 minute, 15 minutes, 30 minutes, and 60 minutes solubilization times compared to all other chitosans. 2. Some Non- LipoSanULTRA™ chitosans increase their oil binding over time while other chitosans exhibit no significant change. 3. The significantly increased oil binding cpacity of Vanson LipoSanULTRA™ following 1 minute is a resut of faster dissolving time. 4. Solubility properties may be more significant for oil binding than deacetylation. NOTES: For each determination, 100g pure corn oil was added to 100ml 0.16N HCl containing 1.00g Chitosan. Vanson LipoSanULTRA™ Patent Pending 20 Absorbitol 10 0 1 15 30 60 MINUTES DISSOVING TIME Rev/April 2002 3 BAYWOOD RESEARCH MODULE Clinical Studies A recent placebo-controlled, double-blinded trial using LipoSanULTRA™ conducted for 8 weeks, demonstrated mean weight, body mass index (BMI), and perfect body fat increased in the placebo group as compared to baseline; additionally, percent lean body mass decreased signicantly in placebo group. Within the treatment group, both mean weight and BMI decreased signicantly compared to baseline over the 8-week period. In contrast to the placebo group which experienced a mean weight gain of 1.5 kg over 8-week period, the mean weight loss in treatment group was 1.0 kg over the same period. A recent placebo-controlled, double-controlled, double-blind trial of Chitosan conducted for six months showed a signicantly higher body weight loss and a decrease in systolic and diastolic blood pressure in the chitosan supplement group compared to the placebo. The mean body weight decrease and body fat decrease was 16.9 kg and 12.3 kg respectively. A meta-analysis study evaluating a number of published randomized, placebo-controlled, double-blind trials of Chitosan results in a signicantly greater weight loss compared with the placebo. How LipSanULTRA™ Achieves Results: LipoSanULTRA™ is a safe and effective weight-loss agent when used in conjunction with a responsible diet. In the digestive system, LipoSanULTRA™ attracts and binds to negatively-charged molecules such as lipids, fatty acids and bile salts. Because LipoSanULTRA™ is a soluble ber that is not digested by the human metabolism, nondigested fats are prevented from being absorbed by the body. LipSanULTRA™ binds to the fatty substances, and is naturally secreted from the body. Glucosamine molecule, the fundamental building block of chitosan In 1995 study, Scuitto reported that overweight subjects treated with hypocaloric diet plus 4 tablets of chitosan each day showed a weight reduction or 10.4%, compared to 3.8% in the placebo group. Arterial systolic pressure reduction was 21.1 mm Hg in the chitosan-treated group, compared to 2.8 mm Hg in the placebo group. Similarly, Giustina reported both increased weight loss, and signicantly greater reduction in systolic and diastolic arterial pressure and respiratory rates in subjects treated with chitosan, as compared to a placebo-treated control group. Quality Control In 1994 study at Ars Medicina in Helsinki, Finland, researchers reported a remarkable capacity of L-112, Natural Nutrition’s proprietary chitosan supplement foundation, to bind fat in the stomach and intestines and lower serum lipids, cholesterol and triglycerides, as well as increased HDL cholesterol levels. This study revealed an effect that was almost 100% better than a control group treated with a placebo, after two weeks. Independent analysis methods are based on the following: Vanson LipoSanULTRA™ is made in the United States by combining high quality raw materials and 20 years of manufacturing experience. Each batch of LipoSanULTRA™ produced is thoroughly analyzed. Additionally, our dietary supplement and pharmaceutical grade material is analyzed by independent laboratories for microbiological activity and heavy metal content. • Guaranteed efcacy: All batches satisfy a minimum fat binding specication of 50 grams bound per gram of LipoSanULTRA™ • Consistent tapped density: 0.5 to 0.6 g/cc • Reliable analysis procedures including: AOAC and EPA standard test methods REFERENCES: 1. Shiller, R.N., Barrager, E., Schauss, A.G., Nichols, E.J. 2001 Submitted for Publication. 2. Krotkiewski, M, Zahorska-Markiewiez, B, Olszaneecka-Glinianowiez, Zurakowski, A, Chitosan as an adjunct to dietary treatment of obesity. (Abstract) 3rd International Symposium on Chitin Anzymology and 4th Conference of the European Chitin Society, May 6-10, 2001, Senigallia, Italy. 3. Ernst, E. and Pittler, M.H., Perfusion, 11, 1998, 461-465. 4. Sciutto A.M. and Colombo P. Acta Toxicol. Ther., Vol. XVI, no. 4. Oct./Dec. 1995. P. 215. Vanson Tests For: • Salmonella • E Coli • Staph, aureus: Listeria, and Pseudomonas • Aerobic Plate Count • Yeast & Molds • Heavy Metals (CD, PB, NI, HG) Rev/April 2002 4 BAYWOOD RESEARCH MODULE Notes: US PA TE N T# 6, 130, 321 8840 152nd Avenue N.E., Redmond, WA 98052-3535 Fax: 425-882-2476 Phone: 425-881-6464 E-mail: [email protected] Website: www.vanson.com COPYRIGHT MISSION OUR COMMITMENT TO CHANGE 2001 Baywood International, Inc. BAYWOOD and “MAKING LIFE BETTER” are marks of Baywood International, Inc. At Baywood, we are ardent advocates for advancing the quality of life. Our goal of “Making Life Better”™ is based around understanding that everyone is unique as individuals so that we can develop nutraceuticals of the highest quality while providing the highest accessibility amongst all consumer channels. At Baywood, we are actively involved in the trends that affect our consumers. As the nutraceutical industry continues to advance, we strive to refine our competitive edge by refining the products we offer to the marketplace. We achieve this objective by identifying new scientific advancements for the ingredients we use and quickly modifying product formulations to changing consumer needs and demands. We ask that you expect this change within our product formulations as you grow with us as a customer. From time-to-time, you might see improvements in products that you already purchase from us. This is our commitment to you as our customer. This is our commitment to change. This is our commitment to “Making LIFE Better”. CORRESPONDENCE Baywood International, Inc. 14950 North 83rd Place, Suite 1 Scottsdale, AZ 85260 DISTRIBUTION We make our Baywood Research Module available to our select retail customers who, in turn, can provide informative infomation for their customers. Send further inquiries to: Rev/April 2002 Additional Copies For more copies of this product module, call (888) 350-0799. 5