Liquid nutritional formula for phenylketonuria patients
This is a process to make a shelf-stable, liquid, ready-to-drink, aseptic nutritional formula for the treatment of PKU, tyrosinemia or other errors of metabolism. The liquid nutritional formula has caseino-glyco-macropeptide as the primary protein source and complementary essential amino acids to complete the requirement profile. The beverage also includes vitamins and minerals sufficient to meet daily requirements. When used as a complete diet, the nutritional formula includes a carbohydrate source and a fat source. The nutritional formula has a pleasant taste.
1. A liquid nutritional formula suitable as a complete diet for phenylketonuria (PKU) comprising whey protein isolate, tyrosine, tryptophan, arginine, leucine, histidine, copper, iron, sodium hexametaphosphate (SHMP), and octenyl succinate starch (OSS), wherein the whey protein isolate consists of caseino-glycomacropeptide (cGMP).
2. The nutritional formula according to claim 1 in which the protein isolate provides 20-35% of the energy of the nutritional formula, fat provides 20% to 30% of the energy of the nutritional formula, and the carbohydrate source provides 40% to 60% of the energy of the nutritional formula.
3. The nutritional formula according to claim 1 , comprising the following complementary amino acids per gram of protein equivalent (PE),
Tyrosine (mg/gm PE)
93
Tryptophan (mg/gm PE)
14
Arginine (mg/gm PE)
90
Leucine (mg/gm PE)
200
Histidine (mg/gm PE)
24.
4. The liquid nutritional formula of claim 3 , which is an emulsion.
5. A liquid nutritional formula comprising:
Calories
200
Cal From Fat
45
Protein Equivalent, g
15
Carbohydrates, g
24
Sugar, g
19
Sugar Alcohols, g
0
Dietary Fiber, g
1
Fat, g
5.0
Saturated Fat, g
2.0
Trans Fat, g
0.0
Cholesterol, mg
0
Vitamin A, IU
900.0
Vitamin C, mg
28.0
Vitamin D, IU
250.0
Vitamin E, IU
5.0
Vitamin K, mcg
30.0
Thiamin (B1), mg
0.4
Riboflavin (B2), mg
0.4
Niacin (B3), mg
5.0
Vitamin B6, mg
0.4
Folic acid, mcg
140.0
Vitamin B12, mcg
0.8
Pantothenic Acid (B5), mg
1.8
Biotin, mcg
8.0
Choline, mg
206.0
Calcium, mg
350.0
Chromium, mcg
13.0
Copper, mg
0.2
Iodine, mcg
57.0
Iron, mg
4.5
Magnesium, mg
120.0
Manganese, mg
0.8
Molybdenum, mcg
15.0
Phosphorus, mg
315.0
Selenium, mcg
20.0
Zinc, mg
3.3
Potassium, mg
340
Sodium, mg
240
Chloride, mg
162.0
Inositol, mg
0.0
L-alanine, mg
560.0
L-arginine, mg
1560.0
L-aspartate, mg
800.0
L-cysteine, mg
10.5
L-glutamate, mg
2000.0
L-glycine, mg
107.0
L-histidine, mg
333.0
L-isoleucine, mg
970.0
L-leucine, mg
3000.0
L-lysine, mg
650.0
L-methionine, mg
152.0
L-phenylalanine, mg
27.0
L-proline, mg
1290.0
L-serine, mg
560.0
L-threonine, mg
1620.0
L-tryptophan, mg
234.0
L-tyrosine, mg
1150.0
L-valine, mg
849.0,
Calories
200
Cal From Fat
45
Protein Equivalent, g
15
Carbohydrates, g
24
Sugar, g
19
Sugar Alcohols, g
0
Dietary Fiber, g
1
Fat, g
5.0
Saturated Fat, g
2.0
Trans Fat, g
0.0
Cholesterol, mg
0
Vitamin A, IU
900.0
Vitamin C, mg
28.0
Vitamin D, IU
250.0
Vitamin E, IU
5.0
Vitamin K, mcg
30.0
Thiamin (B1), mg
0.4
Riboflavin (B2), mg
0.4
Niacin (B3), mg
5.0
Vitamin B6, mg
0.4
Folic acid, mcg
140.0
Vitamin B12, mcg
0.8
Pantothenic Acid (B5), mg
1.8
Biotin, mcg
8.0
Choline, mg
206.0
Calcium, mg
350.0
Chromium, mcg
13.0
Copper, mg
0.2
Iodine, mcg
57.0
Iron, mg
4.5
Magnesium, mg
120.0
Manganese, mg
0.8
Molybdenum, mcg
15.0
Phosphorus, mg
315.0
Selenium, mcg
20.0
Zinc, mg
3.3
Potassium, mg
340
Sodium, mg
240
Chloride, mg
162.0
Inositol, mg
0.0
L-alanine, mg
560.0
L-arginine, mg
1560.0
L-aspartate, mg
800.0
L-cysteine, mg
10.5
L-glutamate, mg
2000.0
L-glycine, mg
107.0
L-histidine, mg
333.0
L-isoleucine, mg
970.0
L-leucine, mg
3000.0
L-lysine, mg
650.0
L-methionine, mg
152.0
L-phenylalanine, mg
27.0
L-proline, mg
1290.0
L-serine, mg
560.0
L-threonine, mg
1620.0
L-tryptophan, mg
234.0
L-tyrosine, mg
1150.0
L-valine, mg
849.0,
Calories
153
Cal From Fat
30
Protein Equivalent, g
10
Carbohydrates, g
22
Sugar, g
17
Sugar Alcohols, g
0
Dietary Fiber, g
0
Fat, g
3.5
Saturated Fat, g
1
Trans Fat, g
0.0
Cholesterol, mg
0
Vitamin A, IU
850.0
Vitamin C, mg
20.0
Vitamin D, IU
250.0
Vitamin E, IU
5.0
Vitamin K, mcg
30.0
Thiamin (B1), mg
0.4
Riboflavin (B2), mg
0.4
Niacin (B3), mg
4.0
Vitamin B6, mg
0.4
Folic acid, mcg
133.0
Vitamin B12, mcg
0.8
Pantothenic Acid (B5), mg
1.8
Biotin, mcg
8.0
Choline, mg
203.0
Calcium, mg
325.0
Chromium, mcg
10.0
Copper, mg
0.2
Iodine, mcg
57.0
Iron, mg
4.0
Magnesium, mg
77.0
Manganese, mg
0.8
Molybdenum, mcg
14.0
Phosphorus, mg
315.0
Selenium, mcg
20.6
Zinc, mg
3.3
Potassium, mg
340
Sodium, mg
250
Chloride, mg
160.0
Inositol, mg
0.0
L-alanine, mg
369.0
L-arginine, mg
1029.6
L-aspartate, mg
567.0
L-cysteine, mg
6.9
L-glutamate, mg
1320.0
L-glycine, mg
76.0
L-histidine, mg
219.0
L-isoleucine, mg
640.0
L-leucine, mg
1980.0
L-lysine, mg
429.0
L-methionine, mg
100.0
L-phenylalanine, mg
18.0
L-proline, mg
851.0
L-serine, mg
369.0
L-threonine, mg
1069.0
L-tryptophan, mg
154.0
L-tyrosine, mg
759.0
L-valine, mg
560.0,
or
Calories
153
Cal From Fat
30
Protein Equivalent, g
10
Carbohydrates, g
22
Sugar, g
17
Sugar Alcohols, g
0
Dietary Fiber, g
1
Fat, g
3.5
Saturated Fat, g
1
Trans Fat, g
0.0
Cholesterol, mg
0
Vitamin A, IU
850.0
Vitamin C, mg
20.0
Vitamin D, IU
250.0
Vitamin E, IU
5.0
Vitamin K, mcg
30.0
Thiamin (B1), mg
0.4
Riboflavin (B2), mg
0.4
Niacin (B3), mg
4.0
Vitamin B6, mg
0.4
Folic acid, mcg
133.0
Vitamin B12, mcg
0.8
Pantothenic Acid (B5), mg
1.8
Biotin, mcg
8.0
Choline, mg
203.0
Calcium, mg
325.0
Chromium, mcg
10.0
Copper, mg
0.2
Iodine, mcg
57.0
Iron, mg
4.0
Magnesium, mg
77.0
Manganese, mg
0.8
Molybdenum, mcg
14.0
Phosphorus, mg
315.0
Selenium, mcg
20.6
Zinc, mg
3.3
Potassium, mg
340
Sodium, mg
250
Chloride, mg
160.0
Inositol, mg
0.0
L-alanine, mg
369.0
L-arginine, mg
1029.6
L-aspartate, mg
567.0
L-cysteine, mg
6.9
L-glutamate, mg
1320.0
L-glycine, mg
76.0
L-histidine, mg
219.0
L-isoleucine, mg
640.0
L-leucine, mg
1980.0
L-lysine, mg
429.0
L-methionine, mg
100.0
L-phenylalanine, mg
18.0
L-proline, mg
851.0
L-serine, mg
369.0
L-threonine, mg
1069.0
L-tryptophan, mg
154.0
L-tyrosine, mg
759.0
L-valine, mg
560.0
per 250 mL of formula, wherein the Protein Equivalent comprises caseino-glycomacropeptide (cGMP), and wherein the formula comprises octenyl succinate starch (OSS) and sodium hexametaphosphate (SHMP).
6. A method of producing a nutritional formula suitable as a complete diet for phenylketonuria, the method comprising:
(a) introducing, caseino-glycomacropeptide (cGMP), amino acids, vitamins and dry ingredients into a metered volume of water to produce a first mixture;
(b) introducing sodium hexametaphosphate (SHMP) and sensitive minerals into a metered volume of water to produce a second mixture;
(c) combining the first mixture and the second mixture;
(d) combining an emulsion comprising tyrosine, octenyl succinate starch (OSS), sodium steroyl lactylate (SSL), cocoa butter, vegetable oil with the product of (c); and
(e) adding Vitamin C to the product of (d), thereby producing a nutritional formula.
7. The method of claim 6 further comprising subjecting the product of (e) to high-shear mixing or blending.
8. The method of claim 7 , wherein the method further comprises the step of storing the nutritional formula under aseptic conditions.
9. The method of claim 7 , wherein the method further comprises aseptically packaging the nutritional formula.
10. A liquid, nutritional formula suitable as a complete diet for phenylketonuria comprising:
Calories
200.00
Cal from Fat
45.00
Protein Equivalent, g
15.00
Carbohydrates, g
24.00
Sugar, g
19.00
Sugar alcohols, g
0.00
Dietary Fiber, g
1.00
Fat, g
5.00
Saturated Fat, g
2.00
Trans Fat, g
0.00
Cholesterol, mg
0.00
Vitamin A, mg
900.00
Vitamin C, mg
28.00
Vitamin D, IU
250.00
Vitamin E, IU
5.00
Vitamin K, mcg
30.00
Thiamin (b1), mg
0.40
Riboflavin (B2), mg
0.40
Niacin (B3), mg
5.00
Vitamin B6, mg
0.40
Folic Acid, mcg
140.00
Vitamin B12, mcg
0.80
Pantothenic Acid (B5),
1.80
mg
Biotin, mcg
8.00
Choline, mg
206.00
Calcium, mg
350.00
Chromium, mcg
13.00
Copper, mg
0.20
Iodine, mcg
57.00
Iron, mg
4.50
Magnesium, mg
120.00
Manganese, mg
0.80
Molybdenum, mcg
15.00
Phosphorus, mg
315.00
Selenium, mcg
20.00
Zinc, mg
3.30
Potassium, mg
340.00
Sodium, mg
240.00
Chloride, mg
162.00
Inositol, mg
0.00
L-alanine, mg
560.00
L-arginine, mg
1560.00
L-aspartate, mg
800.00
L-cysteine, mg
10.50
L-glutamate, mg
2000.00
L-glycine, mg
107.00
L-histidine, mg
333.00
L-isoleucine, mg
970.00
L-leucine, mg
3000.00
L-lysine, mg
650.00
L-methionine, mg
152.00
L-phenylalanine, mg
27.00
L-proline, mg
1290.00
L-serine, mg
560.00
L-threonine, mg
1620.00
L-tryptophan, mg
234.00
L-tyrosine, mg
1150.00
L-valine, mg
849.00
per 250 mL of formula, wherein the Protein Equivalent comprises caseino-glycomacropeptide (cGMP), and wherein the formula comprises octenyl succinate starch (OSS) and sodium hexametaphosphate (SHMP).
11. A liquid, nutritional formula suitable as a complete diet for phenylketonuria comprising:
Calories
153.00
Cal from Fat
30.00
Protein Equivalent, g
10.00
Carbohydrates, g
22.00
Sugar, g
17.00
Sugar alcohols, g
0.00
Dietary Fiber, g
1.00
Fat, g
3.50
Saturated Fat, g
1.00
Trans Fat, g
0.00
Cholesterol, mg
0.00
Vitamin A, mg
850.00
Vitamin C, mg
20.00
Vitamin D, IU
250.00
Vitamin E, IU
5.00
Vitamin K, mcg
30.00
Thiamin (b1), mg
0.40
Riboflavin (B2), mg
0.40
Niacin (B3), mg
4.00
Vitamin B6, mg
0.40
Folic Acid, mcg
133.00
Vitamin B12, mcg
0.80
Pantothenic Acid (B5),
1.80
mg
Biotin, mcg
8.00
Choline, mg
203.00
Calcium, mg
325.00
Chromium, mcg
10.00
Copper, mg
0.20
Iodine, mcg
57.00
Iron, mg
4.00
Magnesium, mg
77.00
Manganese, mg
0.80
Molybdenum, mcg
14.00
Phosphorus, mg
315.00
Selenium, mcg
20.60
Zinc, mg
3.30
Potassium, mg
340.00
Sodium, mg
250.00
Chloride, mg
160.00
Inositol, mg
0.00
L-alanine, mg
369.00
L-arginine, mg
1029.60
L-aspartate, mg
567.00
L-cysteine, mg
6.90
L-glutamate, mg
1320.00
L-glycine, mg
76.00
L-histidine, mg
219.00
L-isoleucine, mg
640.00
L-leucine, mg
1980.00
L-lysine, mg
429.00
L-methionine, mg
100.00
L-phenylalanine, mg
18.00
L-proline, mg
851.00
L-serine, mg
369.00
L-threonine, mg
1069.00
L-tryptophan, mg
154.00
L-tyrosine, mg
759.00
L-valine, mg
560.00
per 250 mL of formula, wherein the Protein Equivalent comprises caseino-glycomacropeptide (cGMP), and wherein the formula comprises octenyl succinate starch (OSS) and sodium hexametaphosphate (SHMP).