Caloric Distribution

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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
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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.