Caloric Distribution
Transcription
Caloric Distribution
ProSure® Shake Therapeutic Nutrition Shake For more information, please visit Prosure.com Usage Features Availability Administration Ingredients Protein Fat Carbohydrate Fiber Vitamins and Minerals Osmotic Concentration Renal Solute Load Analysis References Usage: PROSURE Shake is therapeutic nutrition for people with cancer cachexia that contains a unique blend of an omega-3 fatty acid and protein clinically shown* to help build muscle and promote weight gain so that strength and physical activity can improve. Results in some patients may be seen in as few as 3 weeks with as little as 2 cans daily! A clinical study1-3 among people with cancer showed that drinking PROSURE Shake daily as part of overall care promoted weight gain, helped build muscle, improved quality of life, increased physical activity level, and increased strength in those who gained weight. The flavor varieties of PROSURE Shake have been selected by people with cancer. *When used as part of overall care in people with cancer z For use with oral diets or tube feedings z Not for use as a sole source of nutrition Features: Per 8-fl-oz can: z z z z z z z 1 g of EPA to help normalize metabolism 17 g of protein to help build lean body mass 300 Cal to provide energy in a small volume 3 g of dietary fiber (from fructooligosaccharides, FOS) 22 g vitamins and minerals Lactose- and gluten-free Three flavors—vanilla, banana, chocolate Caloric Distribution The caloric density of PROSURE Shake is 1.27 Cal/mL. This caloric concentration benefits people with cancer who often have a poor appetite and limited food intake, but who have high calorie needs. The higher caloric density minimizes the volume needed to provide adequate supplementation. Per 8 fl oz % Calories Calories 300 — Protein, g 17 22.7 Total Fat, g 7 20.7 Total Carbohydrate, g 44** 56.6 Water, g* 188 — * 1 g water = 1 mL water = 1 cc water ** Includes 3 g of dietary fiber (3 g FOS) Availability: 8-fl-oz cans; 4/carton; 24/case Flavor List Number Vanilla (Instit.) 57024 Vanilla (Retail) 55774 Banana (Instit./Retail) 55780 Chocolate (Instit.) 57025 Chocolate (Retail) 55777 See the Reimbursement section of Ross.com for third-party reimbursement information. The Reimbursement link can be found at the top of each page of Ross.com. Product information and values listed are subject to change. Please refer to product label or packaging for the most current information. Patients can order PROSURE Shake for home delivery by calling 1-800-986-8502 or online at www.prosure.com. Use under medical supervision. Administration: Use by date on container. For use with oral diets or tube feedings. Recommended intake is 2 cans/day. Initiate tube feeding with 2 cans/day of PROSURE Shake and make up remainder of calories with an appropriate tube feeding product, eg, Jevity® 1.2 Cal, Glucerna®, or Optimental®. PROSURE Shake has not been tested for sole-source nutrition. Not for parenteral use. Use under medical supervision. Click Here To View Administration Schedule. Ingredients: (Vanilla): Water, corn maltodextrin, sodium and calcium caseinates, milk protein isolate, sugar (sucrose), corn syrup, sardine oil, fructooligosaccharides, medium chain triglycerides, natural & artificial flavors, sodium citrate, potassium citrate, canola oil, magnesium chloride, calcium phosphate, soy oil, lecithin, magnesium phosphate, choline chloride, ascorbic acid, taurine, potassium chloride, L-carnitine, dl-alpha-tocopheryl acetate, zinc sulfate, ascorbyl palmitate, carrageenan, niacinamide, calcium pantothenate, manganese sulfate, vitamin A palmitate, mixed tocopherols, thiamine chloride hydrochloride, pyridoxine hydrochloride, riboflavin, folic acid, biotin, chromium chloride, sodium molybdate, sodium selenate, potassium iodide, phylloquinone, cyanocobalamin, and vitamin D3. (7749-01) (Chocolate): Water, corn maltodextrin, sodium and calcium caseinates, milk protein isolate, sugar (sucrose), corn syrup, sardine oil, fructooligosaccharides, cocoa powder (processed with alkali), medium chain triglycerides, sodium citrate, potassium citrate, canola oil, magnesium chloride, calcium phosphate, soy oil, natural and artificial flavor, lecithin, magnesium phosphate, choline chloride, ascorbic acid, taurine, potassium chloride, L-carnitine, dl-alpha-tocopheryl acetate, zinc sulfate, ascorbyl palmitate, carrageenan, niacinamide, calcium pantothenate, manganese sulfate, vitamin A palmitate, mixed tocopherols, thiamine chloride hydrochloride, pyridoxine hydrochloride, riboflavin, folic acid, biotin, chromium chloride, sodium molybdate, sodium selenate, potassium iodide, phylloquinone, cyanocobalamin, and vitamin D3. (7875-01) (Banana): Water, corn maltodextrin, sodium and calcium caseinates, milk protein isolate, sugar (sucrose), corn syrup, sardine oil, fructooligosaccharides, calcium caseinate, medium chain triglycerides, potassium citrate, sodium citrate, canola oil, magnesium chloride, calcium phosphate, soy oil, natural and artificial flavors, lecithin, magnesium phosphate, choline chloride, ascorbic acid, taurine, potassium chloride, L-carnitine, dl-alpha-tocopheryl acetate, zinc sulfate, ascorbyl palmitate, carrageenan, niacinamide, calcium pantothenate, manganese sulfate, vitamin A palmitate, mixed tocopherols, thiamine chloride hydrochloride, pyridoxine hydrochloride, riboflavin, folic acid, cyanocobalamin, biotin, chromium chloride, sodium molybdate, sodium selenate, potassium iodide, phylloquinone, and vitamin D3. (7749-01) Protein: PROSURE Shake contains 17 g of protein in each 8-fl-oz serving. This high-protein formula is designed to meet increased protein requirements, promote anabolism, and maintain lean body mass in patients with cancer. The total Cal/N ratio is 110:1—a ratio of 100:1 to 150:1 is appropriate to meet the needs of stressed patients.4,5 The amino acid profile of the protein system in PROSURE Shake meets or surpasses the standard for high-quality protein set by the National Academy of Sciences.6 Protein Profile Percent of total calories from protein 22.7 Protein content 17 g/8 fl oz Fat: PROSURE Shake has a low fat content—7 g of fat per 8-fl-oz serving—because many people with cancer have difficulty digesting and tolerating fats. Diets low in fat sometimes are recommended to help alleviate the side effects associated with cancer and/or cancer treatments such as delayed gastric emptying and feelings of early satiety.7 The fat source is a blend of refined, deodorized sardine oil, medium-chain triglycerides (MCTs), canola oil, soy oil, and lecithin. MCTs are helpful if fat absorption has been altered as a result of cancer treatment. They are a source of easily absorbed energy.8,9 PROSURE Shake contains 1 g of EPA, a long-chain polyunsaturated fatty acid (PUFA) of the omega-3 (n-3) family, per 8-fl-oz serving. Two cans of PROSURE Shake per day provide the optimal level of 2 g of EPA. In clinical studies, EPA has been shown to attenuate the metabolic changes associated with cancer-induced weight loss.10,11 Fat Profile Percent of total calories from fat 20.7 Total Fat 7 g/8 fl oz Polyunsaturated fatty acids 3.1 g/8 fl oz Monounsaturated fatty acids 1.4 g/8 fl oz Saturated fatty acids 2.3 g/8 fl oz Eicosapentaenoic acid 1 g/8 fl oz Carbohydrate: PROSURE Shake provides 44 g of carbohydrate per 8-fl-oz serving, 10 g of which come from sugar (sucrose). The carbohydrate and fiber sources include corn syrup solids, maltodextrin, sucrose, and fructooligosaccharides (FOS). The carbohydrate blend is relatively low in sucrose for people with cancer, who prefer less-sweet-tasting products. The carbohydrate system in PROSURE Shake is designed to provide readily digestible, absorbable carbohydrate for energy, as well as soluble fiber to promote normal bowel function and gastrointestinal health. PROSURE Shake contains 3 g of fiber per 8-fl-oz serving—FOS (fructooligosacharides)—to maintain digestive tract health. FOS are indigestible, highly fermentable carbohydrates that occur naturally in many foods, such as onions, bananas, tomatoes, honey, garlic, barley, and wheat. FOS are prebiotics that stimulate the growth of beneficial GI bacteria (eg, bifidobacteria). FOS are fermented to short-chain fatty acids (SCFAs) that perform many beneficial functions within the digestive tract,12 and help create an unfavorable environment for Clostridium difficile in at-risk patients.13-15 SCFAs are a preferred energy source for cells of the colon, helping to maintain GI tract integrity. FOS stimulate water and electrolyte uptake in the colon, which is important in the management of diarrhea. This enhanced absorption may have important implications for people with cancer who are experiencing diarrhea.16 Carbohydrate Profile Percent of total calories from carbohydrate 56.6 Total carbohydrate 44 g/ 8 fl oz Fiber: Vitamins and Minerals: PROSURE Shake contains 22 vitamins and minerals. See Vitamins and Minerals charts for further details. Osmotic Concentration: The osmotic concentration is determined by the level and form of protein and carbohydrates and the level of electrolytes. PROSURE Shake contains corn syrup solids, maltodextrin, sucrose, and FOS as the carbohydrate source, and an intact protein system. Osmolality (mOsm/kg H2O) 600 Osmolarity (mOsm/L) 475 Renal Solute Load: Renal solute load represents the solutes excreted per liter of product consumed. The major determinants of renal solute load are dietary protein and electrolytes. Each milliequivalent of sodium, potassium, and chloride contributes approximately 1 mOsm to the renal solute load; in adults, each gram of protein contributes approximately 5.7 mOsm. Renal Solute Load (RSL) 559 mOsm/L Analysis: Nutrient Facts 8-fl-oz Vanilla FAN (label number) 7749-01 Cal/mL 1.27 Energy, Cal 300 Protein, g 17 % of total Calories 22.7 Fat, g 7.0 % of total Calories 20.7 Cholesterol, mg 10 Carbohydrate, g 44 % of total Calories 56.6 Water, g* 188 Dietary Fiber, g 3.0 L-carnitine, mg 30 Taurine, mg 45 m-Inositol, mg * 1 g water = 1 mL water = 1 cc water. Dietary fiber includes 3 g of fructooligosaccharides. Vitamins 8-fl-oz Vanilla Vitamin A, IU 2530 Vitamin D, IU 160 Vitamin E, IU 15 Vitamin K, mcg 20 Vitamin C, mg 30 Folic Acid, mcg 160 Thiamin (Vitamin B1), mg 0.6 Riboflavin (Vitamin B2), mg 0.68 Vitamin B6, mg 0.8 Vitamin B12, mcg 2.4 Niacin, mg 8 Choline, mg 120 Biotin, mcg 120 Pantothenic Acid, mg 4 Minerals 8-fl-oz Vanilla Sodium, mg (mEq) 360 (15.7) Potassium, mg (mEq) 390 (10.0) Chloride, mg (mEq) 360 (10.2) Calcium, mg 350 Phosphorus, mg 250 Magnesium, mg 100 Iodine, mcg 38 Manganese, mg 1.3 Copper, mg 0.02 Zinc, mg 6 Iron, mg 0.32 Selenium, mcg 18 Chromium, mcg 30 Molybdenum, mcg 38 Amino Acids 8-fl-oz Vanilla Essential Histidine, mg 490 Isoleucine*, mg 887 Leucine*, mg 1736 Lysine, mg 1383 Methionine, mg 495 Phenylalanine, mg 895 Threonine, mg 755 Tryptophan, mg 205 Valine*, mg 1136 Nonessential Alanine, mg 560 Arginine, mg 623 Aspartic Acid, mg 1299 Cystine, mg 96 Glutamic Acid, mg 3969 Glycine, mg 3321 Proline, mg 1862 Serine, mg 1014 Tyrosine, mg 757 * Branched-chain amino acids. Fatty Acid Profile of ProSure (Vanilla) Fatty Acid mg/8 fl oz* Caprylic (8:0), mg 831 Capric (10:0), mg 623 Palmitic (16.0), mg 416 Palmitoleic (16:1n-7), mg 293 Stearic (18:0), mg 93 Oleic (18:1n-9), mg 1057 Linoleic (18:2n-6), mg 619 Alpha-Linolenic (18:3n-3), mg 164 Gamma-Linolenic (18:3n-6), mg 12 Eicosapentaenoic (20:5n-3), mg 1026 Docosapentaenoic (22:5n-3), mg 102 Docosahexaenoic (22:6n-3), mg 474 Myristic, mg 210 Lauric, mg 20 *Fatty acids equal approximately 95% of total fat. Caproic acid is not detectable. Other Values Density at 23°C, g/mL 1.107 pH 6.6 Osmolality, mosm/kg H2O 635 Osmolarity, mosm/L 503 Renal Solute Load, mosm/L 545 Cal to meet 100% RDIs mL to meet 100% RDIs Total Cal/g nitrogen 117:1 Nonprotein Cal/g nitrogen 92:1 References: Clinical Research A clinical study among people with cancer showed that drinking PROSURE Shake as part of overall care: z z z z z Promoted weight gain Helped build muscle Improved quality of life Increased physical activity level Increased strength in those who gained weight PROSURE Shake has been evaluated in a pilot study and a randomized, double-blind controlled trial. Pilot Study PROSURE Shake was given to 20 weight-losing patients with unresectable pancreatic cancer.17 Prior to enrollment in the study, patients had a median weight loss of 2.9 kg (6.4 lb)/month and were severely malnourished (82% of usual body weight). Patients were asked to drink two cans (8 fl oz/can) of PROSURE Shake per day for 7 weeks. The median consumption was 1.9 cans of PROSURE Shake per day. A significant increase in the level of EPA in plasma phospholipids verified patients were compliant with the supplement. Patients experienced significant weight gain at both 3 weeks (median 1.0 kg [2.2 lb], P = 0.024) and 7 weeks (median 2.0 kg [4.4 lb], P = 0.028). In addition, patients demonstrated a significant improvement in dietary intake, an increase of a median 372 kcal/day over baseline at 3 weeks (P = 0.002). Bioelectrical impedance analysis showed that the weight gain was predominantly lean body mass, and patients' fat mass remained stable. There was no change in total body water, which indicated weight gain was not due to edema or ascites. There also was a significant increase in functional status (Karnofsky Performance Status) and a significant reduction in resting energy expenditure (REE). This study suggests that in contrast to conventional nutritional supplements, PROSURE Shake promotes weight gain in patients with advanced pancreatic cancer. The study also showed that 88% of the patients with pancreatic cancer had proteolysis-inducing factor (PIF) present in their urine at the beginning of the study. PIF is produced by the tumor and initiates the breakdown of muscle. After 3 weeks of supplementation with PROSURE Shake, only 40% had PIF in their urine. This suggests that by decreasing the level of PIF in the urine, PROSURE Shake may have prevented the loss of lean body mass in some patients.18 After 3 weeks of supplementation with PROSURE Shake, there was also a significant decrease in IL-6 production (from median 16.5 to 13.7 ng/mL, P = 0.0015) and a trend for decrease in IL-1 production (P = 0.068).18 Randomized Trial In a randomized, double-blind controlled trial, PROSURE Shake was compared to an isonitrogenous, isocaloric nutritional supplement (control) in a study of 200 patients with pancreatic cancer.1 Before the study, these patients were losing weight at a rate of 3.3 kg (7.3 lb)/month. Patients were asked to consume two cans of PROSURE Shake or the control supplement per day for 8 weeks. Weight, lean body mass (LBM), and quality of life (EORTC QLQ-C30 and EQ-5D) were measured. Intake of PROSURE Shake significantly correlated with change in weight (r = 0.50, P < 0.001), LBM (r = 0.33, P = 0.036), and quality of life as measured by the EQ-5D index (r = 0.37, P = 0.01). Similar correlations were not observed in the control group. Thus, PROSURE Shake use was associated with improvements in weight, LBM, and quality of life. As part of this study, the effect of PROSURE Shake on physical activity level was measured in 19 subjects participating at one site.3 Total energy expenditure (TEE) was measured by doubly labeled water technique over the first 14 days of the study and again between 6 and 8 weeks. Resting energy expenditure (REE) was measured on day 14 on each occasion by indirect calorimetry. Physical activity level (PAL) was calculated (PAL = TEE/REE). Over the 8-week study period, there was no significant change in PAL in the control group (n = 12). In contrast, the PROSURE Shake group (n = 7) experienced a significant increase in PAL (P = 0.005). This study demonstrates that patients with pancreatic cancer and weight loss experience an increase in PAL with PROSURE Shake supplementation. References 1. Fearon KCH, von Meyenfeldt MF, Moses AGW, et al: Effect of a protein and energy dense n-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia. Gut 2003;53:1479-1486. 2. von Meyenfeldt MF, Ferguson M, Voss A, et al: Weight gain is associated with improved quality of life in patients with cancer cachexia consuming an energy and protein dense, high n3 fatty acid oral supplement. Proc Am Soc Clin Oncol 2002;21(1):385A. 3. Moses AGW, Slater C, Preston T, et al: Reduced total energy expenditure and physical activity in cachectic patients with pancreatic cancer can be modulated by an energy and protein dense oral supplement enriched with n-3 fatty acids. Br J Cancer 2004;90:996-1002. 4. Long CL, Schaffel N, Geiger JW, et al: Metabolic response to injury and illness: Estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN 1979;3:452456. 5. Martin C: Calorie, protein, fluid, and micronutrient requirements, in McCallum PD, Polisena CG (eds): The Clinical Guide to Oncology Nutrition. Chicago: American Dietetic Association, 2000, p 47. 6. Food and Nutrition Board, National Research Council: Recommended Dietary Allowances, ed 10. Washington, DC: National Academy of Sciences, 1989. 7. Charuhas PM: Medical nutrition therapy in bone marrow transplantation, in McCallum PD, Polisena CG (eds): The Clinical Guide to Oncology Nutrition. Chicago: American Dietetic Association, 2000, pp 90-98. 8. Akrabawi AA, Morbarhan S, Stoltz RR, Ferguson PW: Gastric emptying, pulmonary function, gas exchange, and respiratory quotient after feeding a moderate versus high fat enteral formula meal in chronic obstructive pulmonary disease patients. Nutrition 1996;12:260-265. 9. Bach AC, Babayan VK: Medium-chain triglycerides: An update. Am J Clin Nutr 1982;36:950962. 10. Wigmore SJ, Fearon KCH, Maingay JP, Ross JA: Down-regulation of the acute-phase response in patients with pancreatic cancer cachexia receiving oral eicosapentaenoic acid is mediated via suppression of interleukin-6. Clin Sci 1997;92:215-221. 11. Wigmore SJ, Barber MD, Ross JA, et al: Effect of oral eicosapentaenoic acid on weight loss in patients with pancreatic cancer. Nutr Cancer 2000;36:177-184. 12. Prosky L, Hoebregs H: Methods to determine food inulin and oligofructose. J Nutr 1999;129 (suppl 7):1418S-1423S. 13. Gibson G, Wang X: Bifidogenic properties of different types of fructooligosaccharides. Food Microbiol (London) 1994;11:491-498. 14. Cummings JH, Macfarlane GT: The control and consequences of bacterial fermentation in the human colon. J Appl Bacteriol 1991;70:443-459. 15. Macfarlane GT, Cummings JH: The colonic flora, fermentation, and large bowel digestive function, in Phillips SF, Pemberton JH, Shorter RG (eds): The Large Intestine: Physiology, Pathophysiology, and Disease. New York: Raven Press, 1991, pp 51-92. 16. Jenkins DJ, Kendall CW, Vuksan V: Inulin, oligofructose and intestinal function. J Nutr 1999;129:1431S-1433S. 17. Barber MD, Ross JA< Voss AC, et al: The effect of an oral nutritional supplement enriched with fish oil on weight-loss in patients with pancreatic cancer. Br J Cancer 1999;8(1):80-86. 18. Barber MD, Fearon KC, Tisdale MJ, et al: Effect of a fish oil-enriched nutritional supplement on metabolic mediators in patients with pancreatic cancer cachexia. Nutr Cancer 2001;40:118124.