Physicians’ Elemental Diet

Physicians’ Elemental Diet 1 unit (11306) and 4 units (11307) PHYSICIANS’ ELEMENTAL DIET™ Physicians’ Elemental Diet is a medical food designed for the dietary management of moderate to severe impaired gastrointestinal (GI) function, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and small intestinal bacterial overgrowth (SIBO). Physicians’ Elemental Diet is designed to maintain nutritional sustenance as the sole source of nutrition for patients under medical supervision. WHAT IT DOES A MEDICAL FOOD FOR THE DIETARY MANAGEMENT OF MODERATE TO SEVERE IMPAIRED GI FUNCTION HOW IT WORKS CLINICAL EVIDENCE OF ELEMENTAL DIETS Published clinical studies have shown that elemental diets are effective for the nutritional management of patients with moderate to severe impaired GI function.1,2 In a clinical study of 93 patients with IBS and abnormal lactulose breath test scores, 80% of those who received an elemental diet had normalized test results with an associated improvement in clinical symptoms after 14 days.3 By 21 days, 85% of those patients saw improvement. Elemental diets can also be effective for managing IBD. In a controlled clinical study, 28 patients with active Crohn’s disease received an elemental diet for 4 weeks with no other food or medication. Clinical remission was achieved in 71% of patients.4 REDUCES THE WORK OF DIGESTION, ALLOWING THE GUT TO REST AND RECUPERATE Physicians’ Elemental Diet contains a balanced blend of macronutrients fortified with essential micronutrients and electrolytes to assure comprehensive support as the sole source of nutritional intake for limited periods. All the ingredients are in their simplest form for easy digestion and the product was designed with a well-tolerated flavor to encourage patient commitment to the diet. This hypoallergenic formula contains no intact proteins, polypeptides, corn, gluten, soy, or dairy. REFERENCES Ueno F et al. J Gastroenterol. 2013;48:31-72. Fisher RL. J Nutr. 1999;129:252S-5S. Pimentel M et al. Dig Dis Sci. 2004;49:73-7. Yamamoto T et al. Inflamm Bowel Dis. 2005;11:580-8. Ingredients Serving Size: 1.26 ounces Amount/Serving %DV Calories 150 … Calories from Fat 35 … Total Fat 4 g … Saturated Fat 4 g … Total Carbohydrate 25 g … Sugars 11 g … Sodium 105 mg … Potassium 150 mg … Protein … … Vitamin A (Beta Carotene) 250 mcg … Vitamin C 20 mg … Calcium 83 mg … Iron 1.5 mg … Vitamin D3 1.67 mcg … Vitamin E 6.7 mg … Vitamin K 10 mcg … Thiamin 0.5 mg … Riboflavin (Riboflavin-5′-phosphate) 0.56 mg … Niacin 3.3 mg … Vitamin B6 (Pyridoxal-5′-phosphate) 667 mcg … Folate (as Quatrefolic® brand (6S)-5-methyltetrahydrofolate,glucosamine salt) 33 mcg … Vitamin B12 (Methylcobalamin) 0.5 mcg … Biotin 50 mcg … Pantothenic Acid 3.3 mg … Choline 33 mg … Phosphorus 116 mg … Iodine 16.5 mcg … Magnesium 33.5 mg … Zinc 2 mg … Selenium 18 mcg … Copper 167 mcg … Manganese 332 mcg … Molybdenum 8.25 mcg … Chloride 142 mg … ** Daily Value (DV) not established †Percent daily value is based on a 2000 calorie diet Other Ingredients dextrose, tapioca maltodextrin, medium chain triglycerides, natural flavor, l-glutamine, l-proline, l-aspartic acid, l-serine, potassium citrate, l-arginine hydrochloride, l-alanine, disodium phosphate, l-leucine, l-lysine hydrochloride, l-valine, l-glycine, calcium glycerophosphate, tricalcium phosphate, l-isoleucine, choline bitartrate, l-threonine, l-tyrosine, magnesium citrate, l-phenylalanine, l-methionine, l-histidine, magnesium glycerophosphate, l-cysteine hydrochloride, potassium chloride, l-tryptophan, sodium ascorbate, l-carnitine l-tartrate, sodium chloride, d-alpha tocopheryl acetate, ferrous gluconate, l-taurine, zinc sulfate, calcium d-pantothenate, beta carotene, niacinamide, sodium selenite, manganese citrate, phytonadione, pyridoxal-5’-phosphate, cholecalciferol, riboflavin5’-phosphate, thiamine hydrochloride, copper sulfate, Quatrefolic® ((6S)-5-methyltetrahydrofolate glucosamine salt), d-biotin, sodium molybdate, potassium iodide, methylcobalamin Physicians’ Elemental Diet™ Does Not Contain Lactose Fructose Sucrose Yeast – Derived Ingredient Gluten Corn Soy Dairy Products Artificial Colors Artificial Flavors Wheat Preservatives sorbitol Mannitol Xylitol Other Details Quatrefolic® is a registered trademark of Gnosis S.p.A. U.S. Patent No. 7,947,662. UPC: 00871791113077 Directions Physicians’ Elemental Diet™ Directions and/or Dosage Thoroughly mix each heaping scoopful (36 g) in 4-8 oz. (118 – 236 mL) chilled or room temperature water. Additional water may be added to the mixture or consumed separately as desired. Consume the mixture slowly over a period of 15 to 60 minutes or more, dependent upon individual comfort. Once mixed, any product that is not consumed after 60 minutes should be refrigerated for a maximum of 24 hours, then shaken or stirred prior to consumption. After opening, store remaining powder in a dry place at room temperature. Warning MEDICAL FOOD INTENDED FOR USE UNDER MEDICAL SUPERVISION Not intended for use in children. Physicians’ Elemental Diet™ is a 100% free form amino acid-based powdered elemental formula intended for distinctive nutritional requirements. Physicians’ Elemental Diet formula provides 150 calories per serving, consisting of 67% carbohydrate, 24% fat and amino acids equivalent to 9% protein. Keep out of reach of children. FAQs Q. How long can Physicians’ Elemental Diet be used as a sole source of nutrition? A. Physicians’ Elemental Diet is designed to maintain nutritional sustenance as a sole source of nutrition for up to four weeks. Typical use is 2-3 weeks in duration. Physicians’ Elemental Diet can also be used in certain applications for just a few days. Longer use (beyond 4 weeks) of Physicians’ Elemental Diet may be used in “half-elemental diet” scenarios, in which 50% or less of calories come from the elemental formula, and the remainder from food sources. Q. Is Physicians’ Elemental Diet hypoallergenic? A. Yes, Physicians’ Elemental Diet is strictly hypoallergenic and does not contain yeast, wheat, gluten, dairy products, fructose, sucrose, lactose, disaccharides, sorbitol, mannitol, xylitol, artificial colors, flavors, soybean oil, soy lecithin, or preservatives. Q. What are the dosing recommendations for Physicians’ Elemental Diet? A. Physicians’ Elemental Diet is designed to be used according to an individual’s caloric needs. Q. Can Physicians’ Elemental Diet be mixed with liquids other than water? A. Physicians’ Elemental Diet is designed to be mixed with water. Other liquids may contain intact proteins and/ or carbohydrates, thus changing the careful balance of macronutrients. Q. Can Physicians’ Elemental Diet be used for enteral tube feeding? A. Physicians’ Elemental Diet is not designed nor tested in enteral tube feeding settings.