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NATURAL HEALTH PRODUCT WORKOUT SUPPLEMENTS This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients described within. Notes Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant’s discretion. The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Date May 6, 2016 Proper name(s), Common name(s), and Source material(s) Group 1: Proteins Proper name(s) Common name(s) Source material Acid casein Acid casein As per NHPID 1 Alfalfa protein concentrate Alfalfa protein concentrate As per NHPID Calcium caseinate Calcium caseinate As per NHPID Calcium sodium caseinate Calcium sodium caseinate As per NHPID Hydrolyzed casein Hydrolyzed casein As per NHPID Defatted wheat germ protein Defatted wheat germ protein As per NHPID Flaxseed protein Flaxseed protein As per NHPID Hemp protein concentrate Hemp protein concentrate As per NHPID Hemp protein isolate Hemp protein isolate As per NHPID Hemp seed protein Hemp seed protein As per NHPID Casein Micelles Micellar casein As per NHPID Milk protein concentrate Milk protein concentrate As per NHPID Milk protein isolate Milk protein isolate As per NHPID Pea protein Pea protein As per NHPID Potato protein Potato protein As per NHPID

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Page 1: NATURAL HEALTH PRODUCT WORKOUT …webprod.hc-sc.gc.ca/.../dbImages/mono_workout-supplements_english.pdfWorkout Supplements Page 4 of 17 Proper name(s) ... Oral Dosage form(s) ... training

NATURAL HEALTH PRODUCT

WORKOUT SUPPLEMENTS

This monograph is intended to serve as a guide to industry for the preparation of Product Licence

Applications (PLAs) and labels for natural health product market authorization. It is not intended

to be a comprehensive review of the medicinal ingredients described within.

Notes

Text in parentheses is additional optional information which can be included on the PLA and

product label at the applicant’s discretion.

The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or

statement may be selected by the applicant.

Date May 6, 2016

Proper name(s), Common name(s), and Source material(s)

Group 1: Proteins

Proper name(s)

Common name(s)

Source material

Acid casein Acid casein As per NHPID1

Alfalfa protein concentrate Alfalfa protein

concentrate

As per NHPID

Calcium caseinate Calcium caseinate As per NHPID

Calcium sodium caseinate Calcium sodium

caseinate

As per NHPID

Hydrolyzed casein Hydrolyzed casein As per NHPID

Defatted wheat germ protein Defatted wheat germ

protein

As per NHPID

Flaxseed protein Flaxseed protein As per NHPID

Hemp protein concentrate Hemp protein

concentrate

As per NHPID

Hemp protein isolate Hemp protein isolate As per NHPID

Hemp seed protein Hemp seed protein As per NHPID

Casein Micelles Micellar casein As per NHPID

Milk protein concentrate Milk protein

concentrate

As per NHPID

Milk protein isolate Milk protein isolate As per NHPID

Pea protein Pea protein As per NHPID

Potato protein Potato protein As per NHPID

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Proper name(s)

Common name(s)

Source material

Rice protein Rice protein As per NHPID

Rice protein concentrate Rice protein

concentrate

As per NHPID

Sodium caseinate Sodium caseinate As per NHPID

Wheat protein isolate Wheat protein isolate As per NHPID

Whey protein isolate Whey protein isolate As per NHPID

Whey protein concentrate Whey protein

concentrate

As per NHPID

Whey protein hydrolysate Whey protein

hydrolysate

As per NHPID

1NHPID: Natural Health Products Ingredients Database

Group 2: Amino acids

Group 2a: Essential amino acids

Proper name(s)

Common name(s)

Source Ingredient(s)

Source Material(s)

L-Histidine L-Histidine L-Histidine

L-Histidine

L-Histidine

hydrochloride

As per NHPID1

L-Isoleucine L-Isoleucine L-Isoleucine

L-Isoleucine

hydrochloride

As per NHPID

L-Leucine L-Leucine L-Leucine

L-Leucine

hydrochloride

As per NHPID

L-Lysine L-Lysine L-Lysine

L-Lysine acetate

L-Lysine

hydrochloride

Lysine dihydrochloride

As per NHPID

L-Methionine L-Methionine L-Methionine

DL-Methionine

As per NHPID

L-Phenylalanine L-Phenylalanine L-Phenylalanine

L-Phenylalanine

methyl ester

DL-Phenylalanine

As per NHPID

L-Threonine L-Threonine L-Threonine

DL-Threonine

As per NHPID

L-Tryptophan L-Tryptophan L-Tryptophan As per NHPID

L-Valine L-Valine L-Valine As per NHPID

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Proper name(s)

Common name(s)

Source Ingredient(s)

Source Material(s)

L-Valine

hydrochloride

DL-Valine 1NHPID: Natural Health Products Ingredients Database

Group 2b: Non-essential amino acids

Proper name(s)

Common name(s)

Source Ingredient(s)

Source Material(s)

L-Alanine L-Alanine L-Alanine

L-Alanine ethyl ester

hydrochloride

DL-Alanine

As per NHPID1

L-Arginine L-Arginine L-Arginine

L-Arginine

hydrochloride

L-Arginine alpha-

ketoglutarate

L-Arginine

ketoisocaproic acid

DL-Arginine

As per NHPID

L-Asparagine L-Asparagine L-Asparagine As per NHPID

L-Aspartic acid L-Aspartic acid L-Aspartate

Potassium aspartate

Potassium magnesium

aspartate

As per NHPID

L-Cysteine L-Cysteine L-Cysteine

L-Cysteine

hydrochloride

L-Cysteine

hydrochloride

monohydrate

As per NHPID

L-Glutamic acid L-Glutamate/L-

Glutamic acid

L-Glutamic acid

L-Glutamic acid

hydrochloride

Monosodium

glutamate

As per NHPID

L-Glutamine L-Glutamine L-Glutamine

L-Glutamine ethyl

ester

As per NHPID

Aminoacetic acid Glycine Glycine

Glycine hydrochloride

As per NHPID

L-Proline L-Proline L-Proline As per NHPID

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Proper name(s)

Common name(s)

Source Ingredient(s)

Source Material(s)

L-Serine L-Serine L-Serine As per NHPID

L-Tyrosine L-Tyrosine L-Tyrosine As per NHPID 1NHPID: Natural Health Products Ingredients Database

Group 3: Carbohydrates

Proper name(s)

Common name(s)

Source material(s)

D-Fructose D-Fructose As per NHPID1

D-Galactose D-Galactose As per NHPID

D-Glucose Dextrose

(D-)Glucose

As per NHPID

Lactose Lactose As per NHPID

Maltodextrin Maltodextrin As per NHPID

D-Mannose D-Mannose As per NHPID

Solanum tuberosum Potato starch Tuber

Oryza sativa Rice starch Grain/seed

Ribose D-Ribose As per NHPID

Sucrose Sucrose

Sugar

Saccharose

As per NHPID

Triticum aestivum Wheat starch Grain/seed

Zea mays Corn Starch

Starch – Maize

Zea mays starch

Grain/seed

Zea mays Waxy maize starch Grain/seed 1NHPID: Natural Health Products Ingredients Database

Group 4: Ergogenic agents

Group 4a: Non-caffeinated ergogenic agents

Proper name(s)

Common name(s)

Source

material(s)/Ingredient(s)

Calcium beta-hydroxy-beta-

methylbutyrate

CaHMB

Calcium beta-

hydroxy-beta-

methylbutyrate

Synthetic

Levocarnitine L-Carnitine

Levocarnitine

As per NNHPD Levocarnitine

monograph

Creatine monohydrate Creatine monohydrate Synthetic

Eleutherococcus senticosus Eleuthero Root

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Siberian ginseng

Panax ginseng Asian ginseng

Chinese ginseng

Korean (red)

ginseng

Panax ginseng

Red ginseng

Ren shen

Root

Group 4b: Caffeine

Proper name(s)

Common name(s)

Source material(s)

Caffeine

Caffeine

As per NHPID1

1NHPID: Natural Health Products Ingredients Database

Group 5: Vitamins and Minerals

Proper name(s)

Common name(s)

Source material(s)

As per the NNHPD Multi-Vitamin/Mineral Supplement monograph

Group 6: Complementary ingredients

Proper name(s)

Common name(s)

Source material(s)/

Ingredient(s)

Malpighia glabra Acerola

Escobillo

Barbados cherry tree

Fruit

Piper nigrum Black pepper Fruit

Beta-Alanine Beta-Alanine As per NHPID1

2-Hydroxy-N,N,N-

trimethylethanaminium

Choline As per NNHPD Choline

AbLS

L-Citrulline (L-)Citrulline Citrulline ethyl ester

Citrulline malate

Capsicum annuum Cayenne (pepper)

Chili pepper

Paprika

Red pepper

Fruit

(all-trans)-Lycopene Lycopene As per NNHPD Lycopene

AbLS

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Proper name(s)

Common name(s)

Source material(s)/

Ingredient(s)

(S)-2,5-Diaminopentanoic acid L-Ornithine As per NHPID

Taurine Taurine As per NHPID 1NHPID: Natural Health Products Ingredients Database

Route of administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules,

chewables (e.g. gummies, tablets), gels, liquids, powders, strips or tablets.

This monograph is not intended to include foods or food-like dosage forms such as bars,

chewing gums or beverages.

Note

Liquids and solutions are not permitted for products containing Creatine monohydrate, due to

lack of stability of the finished product (Dash and Sawhney 2002).

Use(s) or Purpose(s) Statement(s) to the effect of

Note

See Ingredient Combination section below.

Products containing at least one ingredient from any of Groups 1, 2a, 2b, 3, 4a or 4b, at or above

the relevant minimum doses indicated in the Dose section below:

Workout supplement

Athletic support

Products containing at least one ingredient from Group 1, at or above the minimum dose

indicated in the Dose section below:

Source of protein for the maintenance of good health1 (CFIA 2012).

Source of protein which helps build and repair body tissues (CFIA 2012).

Source of amino acids involved in muscle protein synthesis (IOM 2002).

Assists in the building of lean muscle [tissue/mass] when combined with regular

[weight/resistance] training and a healthy balanced diet (NNHPD 2013).

Products containing at least one ingredient from Group 2a, at or above the respective minimum

dose indicated in the Dose section below:

Source of (an) essential amino acid(s) for the maintenance of good health1 (CNF 2012).

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Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (IOM

2002).

Assists in the building of lean muscle [tissue/mass] when combined with regular

[weight/resistance] training and a healthy balanced diet (NNHPD 2013).

Products containing all three of L-leucine, L-isoleucine and L-valine, at or above the respective

minimum doses indicated in the Dose section below:

Source of branched chain amino acids (BCAAs), which are involved in protein synthesis

(IOM 2002).

Products containing at least one ingredient from Group 2b, at or above the respective minimum

dose indicated in the Dose section below:

Source of (an) amino acid(s) involved in muscle protein synthesis (IOM 2002).

Products containing L-glutamine, at or above a minimum dose of 5 g per day:

:

Helps restore plasma glutamine levels depleted after periods of physical stress (e.g.

prolonged exhaustive exercise) (NHPID 2008b).

Helps to assist in muscle cell repair after exercise (NHPID 2008b; IOM 2002).

Products containing at least one ingredient from Group 3, at or above the minimum dose

indicated in the Dose section below:

Source of carbohydrates to support energy production (IOM 2002).

Source of calories which contributes to weight gain (IOM 2002).

Helps to [maintain performance/promote endurance] in extended (greater than 60 min),

high intensity exercise. (Kerksick et al. 2008).

Products containing at least one ingredient from Group 4a, at or above the relevant minimum

doses indicated in the Dose section below:

Helps increase physical performance during intensive exercise (NNHPD 2013).

Additionally, the following recommended uses may be indicated for products containing

the corresponding medicinal ingredients, at or above the relevant minimum doses

indicated in the Dose section below:

Calcium beta-hydroxy-beta-methylbutyrate:

“Enhances muscle strength in previously untrained individuals in

combination with intense resistance training exercise” (NNHPD 2013).

L-Carnitine/Levocarnitine:

Any recommended uses as per the NNHPD L-Carnitine Monograph.

Creatine monohydrate:

Any recommended uses as per the NNHPD Creatine Monohydrate

Monograph.

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Eleuthero/Siberian ginseng:

“Eleuthero/Siberian ginseng is used in Herbal Medicine to help improve

physical performance after periods of physical exertion” (NHPID 2008a).

Panax ginseng:

“(Chinese/Korean/Panax) ginseng is used in Herbal Medicine to help

enhance physical capacity/performance (in cases of physical stress)”

(NHPID 2009).

Products containing caffeine (Group 4b), at or above the minimum dose indicated in the Dose

section below:

Helps (temporarily) to relieve fatigue, to promote endurance, and to enhance motor

performance (Philip et al. 2006; Doherty and Smith 2005; Smith et al. 2005).

Products containing ingredients from Group 5, at or above the minimum doses indicated in the

Dose section below:

As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Ingredient Combinations

All ingredients included in this monograph may be combined together, across all Groups, with

the following restriction:

Products containing caffeine must indicate the recommended use or purpose for Group

4b, and may not indicate any recommended uses or purposes with the wording “for the

maintenance of good health”.

Dose(s)

Subpopulation

Adults ( ≥ 18 years)

Quantity(ies)

Note

The minimum doses indicated below must be met only for medicinal ingredients which are

directly supporting any indicated recommended uses or purposes, as per the Use(s) or Purpose(s)

section above.

Group 1 (Proteins):

The potency of protein on a ‘as is’ weight basis is required to be indicated on the Product

License Application and label for each medicinal ingredient from Group 1.

Total amount of protein on a ‘as is’ weight basis from Group 1 in the product:

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2.6-90 g, per day (NHPID 2013a; IOM 2002).

Group 2a (Essential amino acids):

Medicinal

Ingredient

Minimum (mg/day)

Maximum

(mg/day)1

Histidine 49 220

Isoleucine 66.5 1065

Leucine 147 1824

Lysine 133 3000

Methionine 66.5 1000

Phenylalanine 115.5 339

Threonine 70 301

Tryptophan 17.5 220

Valine 84 1194 Note: References for doses are from NNHPD 2013. 1 When combining individual amino acids with protein ingredients, applicants must consider the contribution of the

protein ingredient(s) to the total dose of each amino acid, in order to respect the maximum doses indicated above.

Group 2b (Non-essential amino acids):

Medicinal

Ingredient

Minimum (mg/day)

Maximum (mg/day) 1

Alanine > 0 363

Arginine > 0 9000

Asparagine > 0 93.5

Aspartic acid > 0 1000

Cysteine > 0 1000

Glutamic acid > 0 1500

Glutamine > 0 9000

Glycine > 0 1800

Proline > 0 519

Serine > 0 351

Tyrosine > 0 3600 Note: References for doses are from NNHPD 2013. 1 When combining individual amino acids with protein ingredients, applicants must consider the contribution of the

protein ingredient(s) to the total dose of each amino acid, in order to respect the maximum doses indicated above.

Group 3 (Carbohydrates):

Combined dose for all ingredients from Group 3 in the product:

6.5-180 g, per day, not to exceed 45 g per single dose (Dietitians of Canada 2013).

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Group 4a (Non-caffeinated ergogenic agents):

Medicinal

Ingredient

Minimum (g/day)

Maximum (g/day)

Calcium beta-

hydroxy-beta-

methylbutyrate1

3 6

L-Carnitine As per NNHPD L-

Carnitine monograph

As per NNHPD L-

Carnitine

monograph

Creatine monohydrate As per NNHPD

Creatine monohydrate

monograph

As per NNHPD

Creatine

monohydrate

monograph

Eleutherococcus

senticosus

0.91 6

Panax ginseng 0.5 9 Note: References for doses are from: NNHPD 2013, NHPID 2009a, 2008a; Rowlands and Thomson 2009;

Gallagher et al. 2000a,b.

Group 4b (Caffeine):

100-400 mg, per day, not to exceed 200 mg per single dose (HC 2012).

Note

Maximum daily dose of 1000 mg from NNHPD Caffeine monograph does not apply for

Workout Supplements as this maximum dose is not acceptable for prolonged use.

Group 5 (Vitamins and Minerals):

As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Group 6 (Complementary ingredients):

Medicinal Ingredient

Minimum

(mg/day)

Maximum (/day)

Malpighia glabra > 0 48 g

Piper nigrum

(non-extracted powder)

> 0 25 mg

Beta-Alanine > 0 3 g

Choline > 0 1000 mg

Citrulline > 0 3000 mg

Capsicum annuum > 0 650 mg

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Lycopene > 0 30 mg

L-ornithine > 0 1500 mg

Taurine > 0 3 g Note: References for doses are from NNHPD 2013; NHPID 2013b,c,d, 2009b,c; CNF 2012.

Directions for use

Products in powder form:

Mix product well in 1-2 cups of liquid (water, juice, etc.) immediately before consumption.

Products for increasing exercise performance (optional):

Consume 45-90 minutes before exercising (Aragon and Schoenfeld 2013).

Products for repairing body tissues/muscles and restoring plasma glutamine levels (optional):

Consume no later than 90 minutes after exercising (Aragon and Schoenfeld 2013).

Products for endurance based on ingredients from Group 3 (Carbohydrates) (optional):

Consume 30-60 g carbohydrates per hour of high intensity exercise (Saunders et al. 2007; Ivy et

al. 2003).

Duration of use

For products containing Eleutherococcus senticosus:

As per NNHPD Eleuthero monograph.

Products containing Panax ginseng:

As per the NNHPD Panax Ginseng Monograph.

Products providing 0.43-9 g per day of L-Arginine:

If you suffer from a cardiovascular disease, consult your health care practitioner for use beyond 6

weeks.

Risk information Statement(s) to the effect of

Caution(s) and warning(s)

All products:

Ensure to drink enough fluid before, during, and after exercise.

If you are pregnant or breastfeeding, consult a healthcare practitioner before using this

product.

Products containing milk derivatives (such as casein/caseinates, whey and milk proteins):

This product contains milk by-products/derivatives.

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Products containing over 30 g per day total protein and/or amino acids (including β-alanine):

If you have liver or kidney disease, consult a health care practitioner prior to use (Shils et al.

2006).

Products containing caffeine:

As per the NNHPD Caffeine Monograph.

Products containing Cayenne:

As per NNHPD Cayenne Monograph

Products containing L-arginine:

As per the NNHPD L- Arginine Monograph

Products containing L-carnitine:

As per the NNHPD L-carnitine Monograph.

Products containing Panax ginseng:

As per the NNHPD Panax Ginseng Monograph

Products containing Creatine monohydrate:

As per the NNHPD Creatine monohydrate monograph.

Products containing Calcium-HMB:

If you are taking medications for high cholesterol, consult a health care practitioner prior to use

(Nissen et al. 2000). Products containing vitamins and/or minerals:

As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Contraindication(s)

Products containing caffeine:

As per the NNHPD Caffeine Monograph.

Products containing L-arginine:

As per the NNHPD L- Arginine Monograph

Products containing Eleutherococcus senticosus:

As per the NNHPD Eleuthero Monograph.

Products containing Panax Ginseng:

As per the NNHPD Panax Ginseng Monograph

Products containing vitamins and/or minerals:

As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.

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Known adverse reaction(s)

Products containing beta-alanine:

May cause a flushing, tingling and/or prickling sensation of the skin, in which case, reduce the

dose. (Harris et al. 2006; Hill et al. 2007; Jordan et al. 2010)

Products containing caffeine:

As per the NNHPD Caffeine Monograph.

For caffeine at or above 200 mg/day:

Caffeine has been shown to reduce blood flow to the heart muscle during exercise which might

lead to cardiovascular complications such as chest pain and irregular heartbeat, even in healthy

individuals. If those symptoms occur discontinue use and consult a health care practitioner

(Higgins 2013).

Products containing Panax ginseng:

As per the NNHPD Panax Ginseng Monograph

Products containing L-arginine:

As per the NNHPD L- Arginine Monograph

Products containing vitamins and/or minerals:

As per the NNHPD Multi-Vitamin/Mineral Supplements Monograph.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and

must meet the limitations outlined in the database.

Storage conditions

Store in a cool, dry place.

Specifications

The finished product specifications must be established in accordance with the requirements

described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality

of Natural Health Products Guide.

The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

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Aragon AA, Schoenfeld BJ. Nutrient timing revisited: is there a post-exercise anabolic window?

Journal of the International Society of Sports Nutrition 2013;10(5).

CFIA 2012 : Canadian Food Inspection Agency. Guide to Food Labelling and Advertising,

Ottawa (ON): Canadian Food Inspection Agency and Health Canada. Internet. [Date modified

2013 July 22]. Available from: http://www.inspection.gc.ca/food/labelling/guide-to-food-

labelling-and-advertising/eng/1300118951990/1300118996556

CNF 2012: Canadian Nutrien File (CNF). Nutrition & Healthy Eating, Food and Nutrition,

Health Canada. [Date Modified 2012 April 26]. Available from: http://webprod3.hc-sc.gc.ca/cnf-

fce/start-debuter.do?lang=eng

Dash AK, Sawhney A. A simple LC method with UV detection for the analysis of creatine and

creatinine and its application to several creatine formulations. Journal of Pharmaceutical and

Biomedical Analysis 2002;29(5):939-945.

Dietitians of Canada 2013. Sports Drinks: Their role in hydration for athletic performance.

[Published 2013 November 12; Accessed 2013 November 10]. Available from:

http://www.dietitians.ca/Nutrition-Resources-A-Z/Factsheets/Sports-Nutrition/Sports-

Drinks.aspx

Doherty M, Smith PM. Effects of caffeine ingestion on rating of perceived exertion during and

after exercise: a meta-analysis. Scandinavian Journal of Medicine & Science in Sports

2005;15(2):69-78.

Gallagher PM, Carrithers JA, Godard MP, Schulze KE, Trappe SW. Beta-hydroxy-beta-

methylbutyrate ingestion, Part I: effects on strength and fat free mass Medicine & Science in

Sports & Exercise 2000 Dec;32(12):2109-15a

Gallagher PM, Carrithers JA, Godard MP, Schulze KE, Trappe SW. Beta-hydroxy-beta-

methylbutyrate ingestion, part II: effects on hematology, hepatic and renal function. Medicine &

Science in Sports and Exercise 2000 Dec;32(12):2116-9b

Harris RC, Tallon MJ, Dunnett M, Boobis L, Coakley J, Kim HJ, Fallowfield JL, Hill CA, Sale

C, Wise JA. The absorption of orally supplied beta-alanine and its effect on muscle carnosine

synthesis in human vastus lateralis. Amino Acids. 2006 May;30(3):279-89.

HC 2012: Caffeine in foods. Health Canada; 2012. [Accessed 2014-04-07]. Available from:

http://www.hc-sc.gc.ca/fn-an/securit/addit/caf/index-eng.php

Higgins JP, Babu KM, Caffeine reduces myocardial blood flow during exercise. Am. J. Med

2013: 126(8): 730-e 1-8.

Hill CA, Harris RC, Kim HJ, Harris BD, Sale C, Boobis LH, Kim CK, Wise JA. Influence of β-

alanine supplementation on skeletal muscle carnosine concentrations and high intensity muscle

capacity. Amino Acids 2007. 32:225-233

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IOM 2002: Institute of Medicine of the National Academies. Dietary Reference Intakes for

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