Contents. Introduction. Marketing Summary. Research Monograph. Scientific Summary & Current Use. Product Label. Approved Claims

Transcription

1 PRODUCT PROFILE

2 Contents 1 Introduction 2 Marketing Summary 3 Research Monograph 4 Scientific Summary & Current Use 5 Product Label 6 Approved Claims 7 Safety Cautions & Assessment 8 Age Guidelines for Use/Shelf Life 9 Glossary 10 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 The energy you need. High-Energy This new high-energy Agel product combines caffeine, vitamins, and selected herbs to create the ultimate high-energy gel for active people. Agel is an energy gel superior in effect to energy drinks. It provides the quick energy you need without the sudden crash*. Benefits Provides a sustained burst of energy in a suspension gel dosage form Supports the synthesis of ATP (natural fuel for the muscles)* Vegetarian and non-gluten ingredients Low glycemic ingredients Excellent source of selected B vitamin ingredients and high potency anti-oxidant Vitamin C Contains Acetyl L-Carnitine (ALC) that has been shown to reduce both physical and mental fatigue associated with aging. ALC is a precursor to the important brain neurotransmitter acetylcholine, which contributes to the support of cognitive function and memory** 2 **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 Research MONOGRAPH Product History & Traditional Use is a new product introduction to Agel in It s formulation represents emerging energy research coupled with traditional research on nutritional ingredients and caffeine. Naturally occurring caffeine is an ingredient in. Caffeine containing plants have played an important role in the civilization of mankind. The cultural and historical use on caffeine containing plants dates back thousands of years. According to Chinese legend, Tea (Camellia sinensis) was discovered when leaves of tea fell into boiling water to create a refreshing and pleasant beverage. The Tea beverage is said to be the second only to water as a consumed beverage. Coffee played a role in cultures and traditions of Africa, Middle East before gaining acceptance in Europe. Chocolate use dates back to ancient civilizations in South America and it was esteemed as a form of valued currency. Guarana has been used by native South American peoples (including the Guaranis) for centuries and was introduced to European settlers as far back as the 16th century. Caffeine containing beverages have played a role in social settings as an element of the cultural fabric of society and human interactions. Examples of caffeine containing plants are listed below: name scientific name source current use* Guarana Paullinia cupana South America Energy, Social Tea Camellia sinensis Asia Social Settings, Mild Energy Coffee Coffea arabica Africa, Middle East Energizing Stimulant Chocolate Theobroma cacao South America Currency, Energy Beverage, Anti-Fatigue Kola Nuts Cola nitida Western Africa Restorative Vitality Yerba Mate Ilex paraguariensis South America Social Beverage Yaupon Ilex vomitoria North America Social Beverage and Purification Description Agel is a blend of naturally occurring caffeine, amino acids, and nutrients formulated in a suspension gel dosage form to deliver the energy nutrients you need.**naturally occurring caffeine is an ingredient in. Each packet contains about 165mg of caffeine or about as much of 2-3 cups of generic brewed coffee. 3

6 Product History Continued The isolation and chemical characterization of caffeine dates back to early 19th century by German, French, and Swedish chemists. The chemical structure of caffeine was identified near the end of the 19th century by Hermann Emil Fischer. He was awarded the Nobel Prize in 1902 in part for his work on the synthesis and characterization of caffeine. The naturally occurring chemical caffeine is one of the few substances that have been used as a food (natural flavoring as a bitter substance), dietary supplement, and as a drug (over the counter mild stimulant). The amount of caffeine and its labeling determine its use. In other words, the product dosage and amount of caffeine are two factors that determine whether caffeine has food, supplement, or drug applications. It is important to use caffeine responsibly. Label directions for caffeine containing products should be followed as misuse of this ingredient can lead to potential adverse reactions. vlt ingredient phytonutrient traditional use* current use** Caffeine Caffeine Food Flavor, Bitter, Energy Dietary Supplement, Food, Pharmaceutical Guarana Extract Caffeine, Theobromine, Theophylline Mood, Memory, Alertness Flavor, Energy, Pharmaceutical Glycine Glycine Nutrition Protein, ATP, Glutathione Synthesis, Antioxidant Acetyl L-Carnitine Acetyl L-Carnitine Nutrition ATP Production Glucuronolactone Glucuronolactone Nutrition, Detoxification Dietary Supplement Vitamin C Vitamin C Scurvy Anti-oxidant Metabolic Support B Vitamins Vitamin B3 (Niacin), B6 (Pyridoxine), B12 (Cyanocobalamin) Nutrients Endurance Check PRO 4 *Traditional use claims have 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 Scientific Summary & CURRENT USE Caffeine is used as a dietary supplement ingredient in. There are about 165 mg of caffeine per dosage that provide energy and nutritional support. Excessive dosages of combined with caffeinated beverages or other sources of caffeine should be avoided. The formulation is designed to incorporate a balanced amount of caffeine and other nutrients to provide short and longer term sustained energy. Energetic effects may last 3-4 hours and complement the longer term energy impacts of nutrients. Preliminary studies have demonstrated that subjects can cycle up to 29% longer during high-intensity circuits after taking caffeine in. Guarana Extract A source of xanthine alkaloids including caffeine, theobromine and theophylline. Guarana contains polyphenols, and catechins and epicatechins (Green Tea type nutrients). It is used as a popular carbonated soft drink and as a dietary supplement ingredient. It is used in to complement the other nutritional ingredients with a balanced nutritional and flavor profile. Glycine acts to support the energy metabolism in the body. It inhibits and neutralizes free radicals that may form during extended exercise. It is key to the synthesis of ATP, glucose and glycogen that provide energy to our bodies. Acetyl L-Carnitine is the acetylated form of L-carnitine. It increases ATP production on a cellular level in our mitochondria and plays a role in the body s energy metabolism. It provides an impact to the cardiac and neuroprotective systems. Glucuronolactone is a precursor for Vitamin C synthesis and both of these substances have been demonstrated to play a role in structural and connective tissues in the body. B Vitamins & Vitamin C Each dosage provides Niacin (B3 at 70% Daily Value), pyridoxine (B6 at 70% Daily Value) and cyanocobalamin (B12 at 23% Daily Value). Each are essential nutrients that have been associated with energy and wellness. Vitamin C at 40 mg or 67% DV per dosage is a recognized anti-oxidant and supports neutralization of free radicals. Vitamin C is recognized in supporting the structural elements of skin, tissues, and bone. Deficiency of Vitamin C has been identified as an element in scurvy (disease of the skin and mucous membranes). Each packet and dosage provides a rich source of B vitamins and Vitamin C. 5

8 Product Label Take one Agel packet a day Agel has been specifically formulated to provide a sustained energy boost that supports concentration, focus and endurance. Allowing you to perform at your best. With B vitamins that are essential for energy, endurance and stamina and low in sugar, gives you the energy you need now.* 6

9 Approved Claims Key Ingredients Caffeine, Glycine, N-Acetyl-L-Carnitine, Glucoronolactone, B-Vitamins, B3 (niacin), B6 (pyridoxine), B12 (cyanocobalamin), Ascorbic acid (Vitamin C) approved Rich, excellent, or high source of high potency anti-oxidant (vitamin C). not approved provides instant energy, all day long. Increases energy to support concentration, focus, and endurance Prevents sickness and disease. The sustained energy boost helps you perform your best. is low in sugar which helps avoid the crash associated with many energy supplements AGEL is a good source of vitamins and minerals. Take one packet of to boost energy and alertness A safe and effective stimulant Notes 1 Not to be used at bed time or prior to retiring for sleep. 2 This product contains about 165mg of caffeine (about as much as 2-3 cups of generic brewed coffee. Do not take this product if you are pregnant, nursing, or sensitive to caffeine. Not for children. Consult your doctor before taking any dietary supplement. 3 is a Vitamin B infused formulation of amino acids and natural caffeine to provide a daily boost of energy. 4 The packet is 1.0 oz.(29.5 g). The existing typical Agel packet gels have a content of 0.75oz (21 g). The Omega 3 packet content is 0.35 oz.(10 g). 7

10 Safety Cautions & ASSESSMENT The safety issues with are primarily associated with the caffeine content. 8 Warning This product contains about 165 mg of caffeine (about as much as 2-3 cups of generic brewed coffee). Do not take this product if you are sensitive to caffeine. Pregnant or lactating women (or those planning pregnancy) should consult their physician prior to using this product. 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, unless there is a reason not to use this product. is intended for adult use. Not for children. It is not intended for use in individuals under 18 years of age. Dosages of more than mg of caffeine (two packets a day) have been associated with sleep disturbance and heart rate impact. Caffeine has GRAS (Generally Regarded as Safe) status in the US. Do not take if you are planning to rest or retire to sleep. Caffeine is an FDA approved ingredient in many over-the-counter drug products. No observable adverse effect level of glucuronolactone at 1000mg/body kg/day. has less than 100mg glucuronolactone per dosage. LD50 of glycine is 7930 mg/kg in rats (oral). has 250 mg of glycine per dosage. Key Ingredients Caffeine, Vitamin C, Vitamin B3, Vitamin B6, Vitamin B12, Glycine, Guarana ext, Acetyl L-Carnitine, Glucuronolactone

11 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 packet daily 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. 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 9

12 Glossary Acetyl L-Carnitine (ALC) The acetyl form of L-Carnitine useful for fatty acid metabolism. Adenosine Tri Phosphate (ATP) It transfers chemical energy within cells for metabolic reactions. It has been called the currency of cellular energy. L-Carnitine Chemical compound that is required for utilization (transport and breakdown) of fats. Nitrogen containing product obtained from biosynthesis of lysine and methionine. Glucuronolactone Chemical compound that is a structural component of connective tissue. Caffeine Naturally occurring phytochemical in selected plants. A xanthine alkaloid. Glucose Naturally occurring sugar. Glutathinone Tri-peptide chemical compound that acts as an antioxidant to protect cells from free radical oxidation or damage. Glycogen A polysaccharide that is the chief storage carbohydrate in animals. Glycine An amino acid. Key for the synthesis of proteins, ATP, glutathione, glucose, glycogen and more. Xanthine Alkaloids Nitrogen containing chemical compounds based on the purine structure, including caffeine, theobromine, and theophylline. Considered to be phytonutrients that act as mild stimulants and bronchodilators. 10

13 References Astorino TA, Roberson DW (January 2010). Efficacy of acute caffeine ingestion for shortterm high-intensity exercise performance: a systematic review. J Strength Cond Res 24 (1): Baker EM, Bierman EL, Plough IC Effect of D-glucuronic acid and D-glucuronolactone on ascorbic acid levels in blood and urine of man and dog. American Journal of Clinical Nutrition. 8: Cao Y, Wang YX, Liu CJ, Wang LX, Han ZW, Wang CB (2009). Comparison of pharmacokinetics of L-carnitine, acetyl-lcarnitine and propionyl-l-carnitine after single oral administration of L-carnitine in healthy volunteers. Clinical and Investigative Medicine 32 (1): E13 9. Safety (MSDS) data for glycine ( physchem.ox.ac.uk/msds/gl/glycine.html html.) Weinberg BA, Bealer BK (2001). Jellin JM, Gregory PJ, et al. Pharmacist s Letter/Prescriber s Letter Natural Medicines Comprehensive Database. 11th Edition. Stockton, CA: Therapeutic Research Facility Peters, Josef M. (1967). Factors Affecting Caffeine Toxicity: A Review of the Literature. The Journal of Clinical Pharmacology and the Journal of New Drugs (7):

14 Nehlig, A; Daval, JL; Debry, G (1992). Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Research Reviews 17 (2): Nehlig A (2010). Is caffeine a cognitive enhancer?. J. Alzheimers Dis. 20 Suppl 1: S Weinberg BA, Bealer BK (2001). The World of Caffeine. Routledge. If you would like to review these 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. Additional Resources 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) Agel Product Shelf Life Agel Quality (QA/QA 2011) To find a reference on PubMed, copy the reference for the article you want to read from the Agel Bibliography page and paste it in the Search PubMed for entry box on the following web page: 12