The Dietary Role of Excipients MARY A. MURRAY, PH.D. SENIOR PRINCIPAL RESEARCH SCIENTIST – AMWAY NUTRILITE HEALTH INSTITUTE AAPS ANNUAL MEETING, SAN DIEGO CA, NOVEMBER 05, 2014 NUTRILITE
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Presentation Outline
Introduction to Calories and Energy
Nutrient Categories
Regulatory View
Macronutrient Labeling Requirements for Dietary Supplements
Nutrient Value of Common and Specialty Excipients
Macronutrient Profile: Report Example for Botanical Supplement
Summary
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How much energy in this piece of cake? a. 350,000 calories b. 350 food calories c. 350 food Cal d. 350 kcal e. 1468 kilojoules (kJ)
Answer: All of the above NUTRILITE
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Definitions: Calories and Energy
The small calorie or gram calorie (symbol: cal) is the approximate amount of energy needed to raise the temperature of one gram of water by one degree Celsius at a pressure of one atmosphere. The large calorie, kilogram calorie, dietary calorie, nutritionist's calorie, nutritional calorie, Calorie (capital C) or food calorie (symbol: Cal) is approximately the amount of energy needed to raise the temperature of one kilogram of water by one degree Celsius. The large Calorie is equal to 1000 small calories or one kilocalorie (symbol: kcal) NUTRILITE
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Definitions: Calories and Energy A joule (symbol J) the heat required to raise the
temperature of 1 g of water by 0.24 K
The kilojoule (kJ) is equal to one thousand (103) joules. In nutritional contexts, the kilojoule (kJ) is the SI unit of food energy. Labels in certain countries express energy in kilojoules (kJ). However, the calorie and kilocalorie are still in common use for Nutrition and food energy NUTRILITE
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Energy Conversion: When referring to Nutrition: 1 Calorie =1 kcal = 4.18 kilojoule (kJ)
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Essential Nutrients
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RDI's and nomenclature established for the following vitamins and minerals which are essential in human nutrition: Vitamin A, Vitamin C, Calcium, Iron, Vitamin D Vitamin E Vitamin K, Thiamin, Riboflavin, Niacin Vitamin B6 Folate VitaminB12 Biotin Pantothenic acid,
5,000 International Units 60 milligrams 1,000 milligrams 18 milligrams 400 International Units 30 International Units 80 micrograms 1.5 milligrams 1.7 milligrams 20 milligrams 2.0 milligrams 400 micrograms, 6 micrograms 300 micrograms 10 milligrams
Phosphorus, Iodine Magnesium Zinc, Selenium, Copper Manganese Chromium, Molybdenum Chloride, Potassium (optional)
1,000 milligrams 150 micrograms 400 milligrams 15 milligrams 70 micrograms, 2.0 milligrams 2.0 milligrams 120 micrograms 75 micrograms 3,400 milligrams
The following synonyms may be added in parentheses immediately following the name of the nutrient or dietary component: Calories--Energy Vitamin C--Ascorbic acid Cite: 21CFR101.9
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Micronutrients (Vitamins)
There are thirteen known vitamins that fall into two groups, those that are water-soluble and those that are fat-soluble.
Water-soluble: B Vitamins (8 in all), Vitamin C
Fat-soluble: Vitamins A, D, E & K
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Minerals are classified as either Macrominerals or Microminerals (Essential Trace Minerals) Macrominerals: Ca,
Mg, P, Na, K, and Cl
Essential trace minerals (Microminerals) chromium,
copper, iodine, iron, manganese, molybdenum, selenium, and zinc NUTRILITE
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Macronutrients: Provide Energy Many commonly used excipients contribute to the macronutrient content of Nutritional Supplements Macronutrient
Calories (Kilocalories)/ gm
Kilojoules/ gm
Protein
4
16.7
Fat
9
37.7
Carbohydrate
4
16.7
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Nutrition Reporting for Dietary Supplements (Focus on Macronutrients)
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Regulatory View: Cite: 21CFR101.9 Nutrition Statements for Dietary Supplements
The term serving or serving size used ( instead of dose ) plus delivery format
Example: - tablets, capsules, stick pack , chew
A statement of Calories per serving rounded to the nearest 5
Energy amounts less than 5 calories per serving may be expressed as zero.
Energy value per serving may also be expressed in kilojoule units, added in parentheses immediately following the statement of the caloric content
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Caloric Content reported as Carbohydrates Protein,and Fat
Total Fat to the nearest gram ( < 0.5 g may be expressed as zero) Saturated Trans
Fat
Fat
Polyunsaturated
Fat (voluntary)
Monounsaturated
Fat (voluntary)
Cholesterol
to nearest 5 mg ( unless 97% (dried substance) 0 0
Sodium Calcium Iron
< 300 ppm < 50 ppm < 10 ppm
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Nutritional Yeast (Specialty Filler)
Nutritional yeasts grown specially for their nutritional value in a nutrient mixture of molasses, then killed through pasteurization and sterilization, dried and sold as powder
Valued for natural Vitamin B and protein content
Often fortified with additional nutrients added to the growth media
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Yeast Provides: micronutrients, macronutrients, macro-minerals, essential trace minerals, fiber Per 100g “As Is”
TYPICAL ANALYSIS
375-395 kcal Fat 2-6 g Saturated 48-60 g Unsaturated 6-.8 g Monounsaturated 25-35 g Polyunsaturated Yeast Provides: micronutrient, macronutrient, 25-35 g Complex Trans Fatty Acidsmacrominerals,Sugars essential