Contents. Introduction. Marketing Summary. Research Monograph. Scientific Summary & Current Use. FIT Challenge & Weight Management Concepts

Transcription

1 PRODUCT PROFILE

2 Contents 1 Introduction 2 Marketing Summary 3 Research Monograph 4 Scientific Summary & Current Use 5 FIT Challenge & Weight Management Concepts 6 Product Label 7 Approved Claims 8 Safety Cautions & Assessment 9 Age Guidelines for Use/Shelf Life 10 Glossary 11 References & Additional Resources

3 PRODUCT PROFILES who we are... Agel Vision The Global Leader in Suspension Gel Technology based Nutritional Products Agel Purpose AGEL and our Product Profiles in Innovation, Research, Quality and Safety provide the necessary components for a confident, well-informed community of empowered team members through: Safe and beneficial products Clear and organized information Compliance to well-defined systems 1

4 Marketing Summary A well-functioning heart is essential for good health. Put Your Heart in the Right Place A well-functioning heart is essential for good health, and the unique blend of nutrients in can help you achieve the best heart possible. The scientifically formulated and technologically advanced gel is designed specifically to help protect your heart and maintain healthy levels of cholesterol.** Can Help You Maintain Healthy Cholesterol Levels Good news is that, in conjunction with diet and exercise, can help you maintain existing healthy cholesterol levels**. Cholesterol is a huge part of heart health. Many life factors can affect cholesterol levels, such as genetics, diet, exercise, and, of course, nutrition. is formulated with Oyster Mushroom, Taurine, and Policosanol to help your body maintain healthy cholesterol levels**. Can Fuel & Protect Your Heart With its blend of anti-oxidants and other nutrients, offers the heart energy and protection. Taurine, for example, supports healthy heart tissue, while carnitine supports the production of myocardial energy production and these are just two examples of all the heart-orientated components found in **. 2 *Traditional Disclaimer: Traditional claims have not been verified by modern research. ** FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

5 Go to the Heart of the Matter The condition of your heart can have a big impact on your life, so you should eat right and exercise. And to augment your healthy-heart lifestyle, consider the unique blend of nutrients in. Additional Benefits Include Provides delivery of ingredients in suspension gel technology dosage form. Contains Enzyme CoQ10 to support the synthesis of ATP and provide heart healthy energy functions**. Excellent source of folic acid and high potency antioxidant selenium. One serving of provides ingredients 100% Daily Value of folic acid and selenium. Oyster Mushroom has been traditionally used to benefit a healthy heart* *Traditional Disclaimer: Traditional claims have not been verified by modern research. 3 ** FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

6 Research MONOGRAPH Product History & Traditional Use is a blend of Oyster Mushroom and a blend of isolated synergistic nutrients to address the needs of heart and cardiovascular health*. The isolated nutrients will be addressed in the scientific content section. The Oyster Mushroom name is based on the resemblance of this mushroom to oysters. Oyster Mushroom is a commonly occurring fungus that has a long history of use as food and medicine in the Asian, Eastern European and European cultures*. Oyster Mushrooms were cultivated during WWI in Germany as a food to support life thru hard times. The history and development of statin medications (pharmaceuticals used as cholesterol lowering agents) are linked to the Oyster Mushroom. Lovastatin, a specific type of statin, naturally occurs in Oyster Mushroom and other natural products. In the 1970s, it was discovered that statins have an inhibitory effect on the enzyme that controls the biosynthesis of low density ( bad ) cholesterol. In other words, research demonstrated that statins could reduce the low density ( bad ) cholesterol in individuals with elevated cholesterol**. In the 1980s after a series of positive safety and efficacy tests, lovastatin was approved for drug use as a cholesterol lowering agent. Since lovastatin naturally occurs in Oyster Mushroom and Red Yeast Rice, the FDA in 1998 placed a ban on the sales of dietary supplements containing these ingredients. This ban was based on FDA recognition of naturally occurring lovastatin as a cholesterol lowering drug. The FDA ban on these ingredients was only temporary as the law upheld that natural products are not patentable. It should be noted that Oyster Mushroom is not a pharmaceutical statin. It is not the same as lovastatin. The distinction is that statins naturally occur in low concentrations in Oyster Mushroom. Many of today s medications are based on natural product discoveries from plants. If the chemistry, politics, regulations are confusing, consider chocolate. Chocolate is a food product that many consider delicious and health promoting, especially dark chocolate. Chocolate contains naturally occurring sugars, fats and nutrients that provide energy. Caffeine is also an ingredient in chocolate. Caffeine has been extracted, purified, synthesized and recognized as a drug ingredient. Banning chocolate and regulating chocolate as a drug based on caffeine would be an extreme measure. Today, Oyster Mushroom is used as a food and dietary ingredient. It is important to read and follow all label instructions to assure responsible use of. GRN 4 *Traditional has not been verified by modern scientific research. **These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

7 Heart Healthy Choices Low stress and manage stress with effective coping strategies High fiber diet with focus on soluble fiber Avoid stimulants including caffeine Make sustainable lifestyle choices Adequate rest and sleep Low fat, low salt diet 7 Weight management 8 9 Quit smoking Have fun 10 Exercise hrt ingredient amount* current use** CoQ10 50mg Energy and cellular support L-Carnitine 500mg Energy to support heart muscle Selenium 70mcg FDA Recognized anti-oxidant 100% DV Taurine 500mg Maintains and supports normal blood pressure Folic Acid 400mcg Supports healthy homocysteine levels Oyster Mushroom 500mg Supports normal cholesterol levels Policosanol 10mg Maintains normal cholesterol balance (HDL/LDL) **These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease 5

8 Scientific Summary Enzyme CoQ10 also known as ubiquinone or CoQ10. A naturally occurring chemical compound in the body that provides energy and fundamental cellular support to the heart**. It is involved in chemical reactions in the heart including electron transport and other functions associated with energy utilization**. L-Carnitine Is a measurement of your body weight relative to your body height. A BMI less than 18.5 is considered underweight. A BMI of is considered normal range. A BMI is considered overweight and a BMI of greater than 30 places a person in the obese category. A healthy weight and BMI is based upon many individual factors and may vary for each person. Selenium from Selenomethionine Is an high potency anti-oxidant when it occurs as an ingredient in dietary supplement products at a dosage of greater than 20% of the daily value. Each packet of contains 100% of the Daily Value (DV) of Selenium from organically bound selenomethionine. Selenium is associated with healthy cholesterol management and provides antioxidant support to the cardiovascular system**. Taurine is a naturally occurring chemical compound in animal tissue (meat and seafood) and is a main constituent of bile. Agel sources a synthetic taurine and avoids the use of animal derived products in its supplements. Taurine is considered essential to support normal cardiovascular function and to maintain normal blood pressure**. Folic Acid or Folate maintains healthy homoscysteine levels. Elevated homocysteine levels have been associated with degradation of the structural elements (collagen, elastin and others) of the artery. Considered essential to the body s processing and clearing homocysteine from the body. Elevated homocysteine levels have been associated with cardiovascular risk**. Oyster Mushroom is derived from Pleurotus ostreatus, a widely used edible mushroom (fungus) and used as an ingredient to support cardiovascular and cholesterol levels**. Also called the Pearl Oyster Mushroom. Oyster Mushroom contains statin-like compounds that have been reported to positively impact blood cholesterol levels by regulating cholesterol metabolism**. The statinlike content in Oyster Mushroom can be up to 2.8% on a dry weight basis. A daily dosage or one packet of contains 500mg of Oyster Mushroom and at 2.8% statin-like content which converts to about 10-15mg per packet. The typical daily pharmaceutical dosage of statin medication is 10-80mg. If you have heart disease, or suspect you have heart disease, or are taking medications, you should consult with your physician prior to using. Policosanol has been associated with improving the balance of High Density Cholesterol and Low Density Levels of Cholesterol**. A positive HDL/LDL ratio has been associated with cardiovascular health. Policosanol has also been associated with maintaining healthy blood flow in the body**. 6 **These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease

9 The Agel Approach to Heart Health ingredients and nutrients can complement a heart healthy lifestyle. Cardiovascular and heart health can be addressed by multiple approaches including dietary nutrition, lifestyle, and preventative healthcare choices. Heart disease, on the other hand is another issue. Heart disease has been referred to as the silent killer. Supplements including are not intended to treat heart disease. If you currently have heart disease or suspect you have heart disease, or if you are taking any medications, you should consult your physician before taking or other dietary supplements to support heart health. It should be noted that there is much still to be learned and researched about the role of supplements, nutrition, medications and lifestyle choices to support heart health. Agel will be updating its Product Profiles to bring you the latest developments in this research. Cardiovascular (Heart) Disease Statistics from 2004 and 2005 Ranked #1 for cause of death Deaths per 100,000 population: Number of deaths in 2004: 654,092 Number of non-institutionalized adults with diagnosed heart disease: 25.6 million Percent of non-institutionalized adults with diagnosed heart disease: 12% Complementary Agel Products Agel Ω-3 (Omega Three) Agel EXO Agel MIN and heart healthy B vitamins (niacin, folic acid). 7

10 Product Label Agel is a remarkable blend of components all shown to promote heart health. strengthens the arteries by maintaining low levels of homocysteine, increases the energy production of the heart muscles, helps maintain existing cholesterol levels, and contains heart-specific anti-oxidants. Be smart!* 8

11 Approved Claims Key Ingredients Enzyme CoQ10 (Coenzyme Q10), Folic Acid, Selenium (as selenomethionine), Oyster Mushroom, Taurine and L-Carnitine, Polycosanol See note #3 below Be smart approved not approved Everyone can benefit from using daily to support cholesterol and blood lipid levels that are within the normal range. An effective and safe treatment for everyone. See note #4 below for recommendation. A rich, high, or excellent source of high potency anti-oxidant selenium in the organically bound form of selenomethionine. will lower blood pressure and is an effective treatment for hypertension. Ingredients in are effective for the treatment of heart disease. 100% guaranteed. Notes The bolded words in the Not Approved column shall be avoided by Agel and CS staff Agel is a remarkable blend of components shown to promote heart health. (ingredients) strengthens the arteries by maintaining low levels of homocysteine, increases the energy production in the heart muscles (muscle), helps maintain existing healthy cholesterol levels and contains heatspecific anti-oxidants. Be smart! Agel label/carton claim is identical to the FDA submitted claim with the following exception. Warning: Pregnant or lactating women, persons with known medical conditions, taking Warfarin (Coumadin) or other blood thinners, and/or taking medications, should consult their physician prior to using this product. Not intended for children The following is a factual statement: The ingredients in work on multiple pathways to support heart health. Enzyme CoQ10 supports and maintains healthy blood pressure levels and supports healthy energy levels in the heart that is already within the normal range. Oyster Mushroom supports and maintains healthy cholesterol levels that are already within the normal range. 9

12 Safety Cautions & ASSESSMENT 1 Pregnant or lactating women (or those planning pregnancy) should consult their physician prior to using this product. 9 WebMD reports that Policosanol is possibly safe at dosages of 10-80mg per day for up to two years for most people. 2 Seek medical advice if you are taking medications including blood thinners (Coumadin, Warfarin, Aspirin), or if have an existing medical condition. 3 If you are planning a surgery, disclose use of Agel and all other dietary supplements to your physician A dosage of one Agel packet a day can be safely used by most people.. is intended for adult use. It is not intended for use in young children. Consult with your healthcare professional prior to using in young children. Taurine has GRAS (Generally Regarded as Safe) status in the US Toxicity risk from folic acid is low,because folate is a water-soluble vitamin and is regularly removed from the body through urine. The Institute of Medicine has set a tolerable upper intake level (UL) of 1 mg folate for adult men and women. Selenium is toxic if taken in excess. Exceeding the tolerable upper intake level (UL) of 400 micrograms per day can lead to adverse reactions including selenosis. contains 70 micrograms of selenium per packet. Key Ingredients Oyster Mushroom, Taurine, L-Carnitine, Coenzyme Q10, Policosanol, Folic Acid, Selenium Toxicity from high dosages of CoQ10 is not typically observed. A daily dosage up to 3600 mg was tolerated by healthy as well as unhealthy individuals. A 2003 study by the European Food Safety Authority found no adverse effects for up to 1,000 mg of taurine per kilogram of body weight per day. This is equivalent to 50,000 mg of taurine or the equivalent found in 100 packets of.

13 Age Guidelines FOR USE age group class approximate age use recommendation Newborn Birth to one month of age Not recommended for use Infant One month to 2 years Not recommended for use Child 2 years to 12 years Not recommended for use Adolescent 12 years to 17 years Not recommended for use Adult 17 years and older 1-2 packets daily or as needed Agel Guidelines 1 2 Individual conditions should be considered when considering use, including weight, sex, pre-existing medical conditions, sensitivity or allergic reactions to ingredients, use of prescription medication or other drugs. The adult use recommendation for adults is 1-2 packets daily or as needed. The term or as needed denotes that individuals may select more than 2 packets daily based on individual need, however, the daily maximum dosage recommended is 3 packets of. 3 Individuals should begin Agel product use with one Agel product at the lowest dosage and increase dosage and add other complementary Agel products as needed. Product Shelf Life Agel has a shelf life of 18 months when stored under ambient conditions 11

14 Glossary 12 Cardiovascular Relating to the heart and blood vessels. Coenzyme Q10 (CoQ10) Vitamin-like substance found primarily in the mitochondria. It is a component of the electron transport chain and generates energy in the form of ATP (Adenosine Triphosphate) Coumadin Brand name for Warfarin. An anti-coagulant blood medication to prevent the formation of blood clots. Folate (Folic Acid) One of the B vitamins. It is essential for many body processes, including the health of the heart, cardiovascular system, nervous system. It protects against certain birth defects. Homocysteine an amino acid. It is similar to cysteine but carries an additional methylene (-CH2-) group. High levels of homocysteine has been linked to cardiovascular disease. Lowering of homocysteine levels is not conclusive in reducing risk of heart disease. Lovastatin A specific type of statin found in Oyster Mushroom and Red Yeast Rice. Used for lowering cholesterol and cardiovascular health. Myocardium (Myocardial) Is an amino acid. It is similar to cysteine but carries an additional methylene (-CH2-) group. High levels of homocysteine has been linked to cardiovascular disease. Lowering of homocysteine levels is not conclusive in reducing risk of heart disease. Oyster Mushroom A mushroom (fungus) derived from the common edible mushroom, Pleurotus ostreatus also known as the Pearl Oyster Mushroom. Policosanol A natural extract of plant waxes associated with cholesterol balance in the body. Reported to lower bad cholesterol (low density cholesterol) and increase good cholesterol. Selenium A trace mineral found in soil and food. It is an anti-oxidant and protects the body s cells. Associated with multiple health implications for the heart, aging, and immune systems. Statins A class of chemical compound drugs that are used to lower cholesterol and treat cardiovascular disease. Lovastatin is a naturally occurring statin found in Oyster Mushroom and Red Yeast Rice. Taurine A chemical compound found in meats and seafood. Primarily occurs in the bile. Essential for cardiovascular function, skeletal muscle, retina and the central nervous system. Warfarin An anti-coagulant blood medication to prevent the formation of blood clots.

15 References Alarcón J, Aguila S, Arancibia-Avila P, Fuentes O, Zamorano-Ponce E, Hernández M (2003 Jan-Feb). Production and purification of statins from Bazzano, LA (2009). Folic acid supplementation and cardiovascular disease: the state of the art. The American journal of the medical sciences 338 (1): Bobek P, Ozdín O, Mikus M (1995). Dietary oyster mushroom (Pleurotus ostreatus) accelerates plasma cholesterol turnover in hypercholesterolaemic rat. Physiol Res 44 (5): Chang, Shu-ting; Miles, Philip G. (2004). Pleurotus A Mushroom of Broad Adaptability. Mushrooms: cultivation, nutritional value, medicinal effect, and environmental impact (2nd ed.). CRC Press. pp Chang, Shu-ting; Miles, Philip G. (2004). Pleurotus A Mushroom of Broad Adaptability. Mushrooms: cultivation, nutritional value, medicinal effect, and environmental impact (2nd ed.). CRC Press. pp Dietary Supplement Fact Sheet: Folate.. Office of Dietary Supplements, National Institutes of Health EFSA adopts opinion on two ingredients commonly used in some energy drinks efsa. europa.eu/ Huxtable, RJ (1992). Physiological actions of taurine. Physiol Rev 72 (1): Jellin JM, Gregory PJ, et al. Pharmacist s Letter/Prescriber s Letter Natural Medicines Comprehensive Database. 11th Edition. Stockton, CA: Therapeutic Research Facility Kamyar Kalantar-Zadeh, MPHa, Stefan D. Anker, Tamara B. Horwich and Gregg C. Fonarow (June 2008). Nutritional and Anti- Inflammatory Interventions in Chronic Heart Failure. The American Journal of Cardiology 101 (11): S89 S103. Linus Pauling Institute at Oregon State University lpi.oregonstate.edu Selenium. Linus Pauling Institute at Oregon State University. Molyneux SL, Florkowski CM, George PM, et al. (October 2008). Coenzyme Q10: an independent predictor of mortality in chronic heart failure. J. Am. Coll. Cardiol. 52 (18): Pons P, Rodriguez M, Robaina C, Illnait J, Mas R, Fernandez L, Fernandez JC. (1994). Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. International Journal of Clinical Pharmacology Research 14 (1):

16 Sarter, B (2002). Coenzyme Q10 and cardiovascular disease: a review. The Journal of cardiovascular nursing 16 (4): Linus Pauling Institute at Oregon State University lpi.oregonstate.edu Selenium. Linus Pauling Institute at Oregon State University. Stamets, Paul (2002).MycoMedicinals. Olympia Washington. MycoMedia Productions, a division of Fungi Imperfecti, LLC. Steiber A, Kerner J, Hoppel C (2004). Carnitine: a nutritional, biosynthetic, and functional perspective. Mol. Aspects Med. 25 (5 6): The United States Pharmacopeial Convention. USP Dietary Supplements Compendium The Authoritative Reference st Edition. Rockville, MD Additional Rescources If you would like to review associated publications in more detail we suggest you use PubMed, the information portal provided by the US National Library of Medicine and the National Institutes of Health. PubMed is a service of the U.S. National Library of Medicine that includes over 17 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s. To find a reference on PubMed, copy the reference for the article you want to read from the Agel references (or website) page and paste it in the Search PubMed for entry box on the following web page: entrez?db=pubmed Some studies are subject to copyright or are otherwise not available to the general public. The following sites may allow access to a portion of these studies and other related information: Pub Med database: US Office of Dietary Supplements: If you would like more scientific information on, go to the Agel website ( under products. Agel Product Profiles and Organization Agel Suspension Gel Technology FAQ US Regulatory Requirements European (EU) Regulatory Requirements Agel Primary Use for All Agel Products Responsible Use of Agel Nutritional Supplements Agel Compliant Claim Guidelines for All Products Agel Product Shelf Life (All Products) Agel Quality (QA/QC 2011) Product Profiles Listing of Item Numbers and Release Dates Product Certification (Halal and Kosher Lists) Agel Glossary (All Products) 14