lifepak ® technical training for medical representative certification written by: carsten r. smidt,...

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LifePak ® Technical Training for Medical Representative Certification Written by: Carsten R. Smidt, Ph.D., F.A.C.N.

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LifePak®

Technical Training for Medical Representative Certification

Written by:

Carsten R. Smidt, Ph.D., F.A.C.N.

The LifePak Family

The LifePak Family

Study Materials

Copy of these slides

Draft, LifePak® Monograph

For internal use only.

Do not copy!

Nutrition 101

Present Knowledge in NutritionSeventh Edition

E. E. Ziegler and L. J. Filer, Jr.

1996, 684 pages, $50.00

ILSI Press, 202-659-0074 x123

[email protected]

Don’t fall asleep!

Possible Exam Items:

What you will learn:

Why take multivitamins? Concept of optimum supplementation LifePak’s 5-in-1 concept

• antioxidants, free radicals & heart health

• B-vitamins & homocysteine

• bone nutrients & osteoporosis

• trace elements & bioavailability

• phytonutrients

What you will learn:

LifePak & Cardiovascular Health, Glucose & Insulin Metabolism, and Immune Function

Key features of other LifePak products LifePak Directions LifePak Safety LifePak Precautions

In other words...

LifePak is the best multivitamin/mineral

supplement -- worldwide!

Why take multivitamins?

To meet the RDAs, I.e., prevent nutrient deficiencies

To improve general well-being, e.g., physical and mental performance

To stay healthy (health insurance in pill form)

Multivitamin Usage

38 % of US population are regular multivitamin users!

What shall we do with the other 62 %?

Recommended Dietary Allowances

RDA Definition: “Intake level of essential nutrients judged to be adequate to meet the needs of practically all healthy persons.”

RDAs prevent classical deficiency diseases:• Vitamin C & Scurvy

• Thiamin & Beri-Beri

RDAs have a safety margin: Less than 2/3rds of RDA = “nutrient deficiency”

RDA, RDI, DV…confusing?

RDA: Recommended Dietary Allowances, NRC Food and Nutrition Board 1989.

NRC Food and Nutrition Board 1998-?

RDI: Recommended Daily Intake,FDA, for labeling, based on 1978 RDAs.

% DV: Daily Value, FDA, % of RDI present in a serving of a food or supplement.

Why take multivitamins?

In a survey of 21,500 people*, not a single person consumed a 100% of RDA for the 10 most important nutrients!

Over 70% of people did not even meet 2/3rds of RDA for one or more nutrients.**

* USDA National Food Consumption Survey 1977-78.

** USDA National Food Consumption Survey 1987-88.

Percent of Adults Not Meeting RDA

0

10

20

30

40

50

60

70

80

90

Vitam

in A

Vitam

in E

Vitam

in C

Thiam

in

Ribofla

vin

Niaci

n

Vitam

in B

6

Folate

Vitam

in B

12

Calci

um

Mag

nesiu

mIro

nZi

nc

Males

Females

Source: USDA 1994-96 CSFII

Eat More Fruits & Vegetables!

Eat Fruits & Vegetables! National Cancer Institute: Eat 5-10

servings to prevent cancer! 90% of Americans eat less than 5 servings

a day.* U.S. average is 3.2 servings/day.* Fruits & vegetables contain vitamins,

minerals, thousands of phytonutrients, dietary fiber and potassium.

*NHANES II data

Are RDAs adequate?

RDAs do not consider optimum intakes.• Vitamin E: 100-400 IU

• Vitamin C: 200-500 mg

• Chromium: 200 mcg

Optimum RDAs are under development by the NRC Food and Nutrition Board (NRC FNB)

Optimum Supplementation

Ensures RDA levels

+

Considers typical dietary intakes

+

Optimum nutrient levels for long-term health

+

Non-essential, beneficial nutrients

What is LifePak?

LifePak is a comprehensive nutritional supplementation program delivering the optimal amounts of all essential vitamins, antioxidants, minerals, and trace elements, as well as beneficial phytonutrients.

LifePak 5-in-1 Concept

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

LifePak Advantages

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

What are Free Radicals?

Free radicals are highly reactive, short-lived compounds that can destroy the body’s fats, proteins and nucleic acids (DNA).

Free radicals are involved in the etiology of:• cardiovascular disease

• cancer

• cataract, macular degeneration

• aging process

What are Free Radicals?

There are many types of free radicals...• HO• hydroxyl radical, 10-9 seconds

• RO• alkoxyl radical, 10-6 seconds

• ROO• peroxyl radical, 7 seconds

• NO• nitric oxide radical, 1-10 seconds

• O2-• superoxide anion radical, enzymic

…and reactive oxygen species (ROS):• 1O2 singlet oxygen, 10-5 seconds

• ONOO- peroxinitrite, 0.05-1 seconds

• H2O2 hydrogen peroxide, enzymic

Free Radical Sources

Environmental pollution Radiation: UV light, X-ray, -ray Smoking: 1016 free radicals/cigarette Normal oxidative metabolism of

carbohydrates, fats & proteins for energy production.

Antioxidants

Capture/neutralize free radicals • (e.g., vitamin E in cell membranes, etc.)

Intrinsic Antioxidants:• albumin, uric acid, a-ox enzymes (GPX, SOD,

catalase), and others.

Extrinsic (Dietary) Antioxidants:• a-ox vitamins, trace element cofactors,

carotenoids, flavonoids, and others.

Antioxidant Effects Decrease free radical damage (oxidation)

• especially in people with high oxidative stress:» smokers, elderly, people in polluted urban areas

Improve cardiovascular health:• Reduce LDL-Oxidation & atherosclerosis

Slow down aging process:• Less DNA & protein damage

Help prevent cancer:• Protect DNA; promote normal cell growth

Antioxidants

Many types of antioxidants must work together (in synergy) to

afford effective protection from free radical damage.

“Antioxidant defense system”

LifePak Antioxidants

Vitamin C, 500 mg Vitamin E, 300 IU, natural Selenium, Zinc, Copper, Manganese alpha-Lipoic acid Phytonutrients:

• Carotenoids

• Flavonoids

Objective of LifePak Studies

Does LifePak supplementation improve antioxidant status and decrease LDL-oxidation in healthy non-smokers consuming typical U.S. diets?

LifePak Antioxidant Studies

Two double-blind studies (FDA-GCP):• 140-subject parallel design (Houston, TX)

• 46-subject cross-over design (Evansville, IN)

• LifePak or placebo for 6 weeks

• Both studies evaluated antioxidant status and LDL oxidizability.

FASEB J. 13(4): A546 (cross-over study) other publications forthcoming.

LifePak Antioxidant Studies

Inclusion/Exclusion Criteria for Subjects: healthy non-smokers men & women, ages 18-65 on typical U.S. Diets <

5 servings of fruits & vegetables per day no other dietary supplements or medications

Serum -Carotene(nmol/L)

(means +/- SD)

331299

335

716

0

200

400

600

800

1000

1200

Baseline Endpoint

PLMVMS

p < 0.001

Serum -Carotene(nmol/L)

(means +/- SD)

122 8577

592

0

200

400

600

800

1000

Baseline Endpoint

PLMVMS

p < 0.001

Serum Vitamin C(mol/L)

(means +/- SD)

70.667.4

94.3

68.1

0

20

40

60

80

100

120

140

Baseline Endpoint

PLMVMS

p < 0.001

Serum Vitamin E (mol/L)

(means +/- SD)

20.619.9

36.9

20

0

10

20

30

40

50

Baseline Endpoint

PLMVMS

p < 0.001

Serum Selenium (mol/L)

(means +/- SD)

2.32.2

2.52.1

0

1

2

3

4

Baseline Endpoint

PLMVMS

p < 0.01

LDL Oxidation

LDL are prone to oxidation by free radicals.

Oxidized LDL tend to adhere to artery walls more than non-oxidized LDL.

Antioxidants can improve LDL’s resistance against free-radical oxidation

Blood Sample

PlasmaLDL isolation

LDL

Copper Ion

Solution

LDL LDL

LDL

LDL Oxidizability

LDL Oxidizability

Time

Oxi

dat

ion

Lag Time

Rate

LDL Oxidizability, lag time(min)

(means +/- SD)

42.1 4243.4

50.9

0

10

20

30

40

50

60

Baseline Endpoint

PLMVMS

p < 0.001

LDL Oxidizability, Rate(mol/min x g protein)

(means +/- SD)

12.7 12.912.5

11.4

0

2

4

6

8

10

12

14

16

18

20

Baseline Endpoint

PLMVMS

p < 0.001

LP Studies: Conclusions

LifePak improved antioxidant status.

LifePak increased LDL’s resistance against free-radical oxidation, and thus, may have cardiovascular benefits.

LifePak is safe and well-tolerated.

LifePak Advantages

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

LifePak B-Vitamins

Balanced accdg. to optimum requirements. Optimum amounts for normal

homocysteine metabolism.• Homocysteine: Undesirable amino acid by-

product from methionine metabolism

• impairs vascular function, atherogenic

• independent risk factor for cardiovascular disease

• B12, Folate & B6 help control homocysteine.

LifePak B-Vitamins

Regular LifePak B-Vitamins: Thiamin (vitamin B1) 3 mg 200 % DV

Riboflavin (vitamin B2) 3.4 mg 200 % DV

Niacin 40 mg 200 % DV

Vitamin B6 (pyridoxine) 10 mg 500 % DV

Folic Acid 600 mcg 150 % DV

Vitamin B12 30 mcg 500 % DV

Pantothenic Acid 30 mg 300 % DV

Biotin 300 mcg 100 % DV

LifePak Advantages

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

Bone Nutrition: Calcium

Calcium (Ca) is the major bone mineral, and it helps prevent osteoporosis.

Calcium intake: 55% of men and 78% of women do not meet the RDA!

Calcium RDA = RDI (DV): 1,000 mg/day 1 gl. of milk = 300 mg calcium = 30 % DV LifePak has 500 mg Ca = 50 % DV

Bone Nutrition

Calcium alone is not the answer!

LifePak Bone NutrientsMagnesium: Like Ca, a structural component 60 % of body’s Mg is in bone Mg supplementation increases BMD Mg also promotes heart rhythm, blood pressure

and muscle function (ATP action). Mg intake: 66% of men and 76% of women do

not meet the RDA! LifePak: 250 mg Mg = 62.5 % DV

LifePak Bone Nutrients

Vitamin D: Fat-soluble vitamin helps regulate Ca, Mg, and bone metabolism functions as a hormone Deficiency is common Experts recommend supplementation with

400 IU daily from multivitamins All LifePaks have 400 IU vitamin D

LifePak Bone Nutrients

Vitamin K: Fat-soluble vitamin promotes Ca incorporation into bone

Boron and Silicon: trace elements support normal bone metabolism

Soy Isoflavones (Phytoestrogens): promote bone mineralization

LifePak Bone Nutrients

Calcium 500 mg 50 % DV

Magnesium 250 mg 62.5 % DV

Vitamin D 400 IU 100 % DV

Vitamin K 40 mcg 50 % DV

Boron 3 mg n/a

Silicon 3 mg n/a

Soy Isoflavones 10 mg n/a

LifePak Advantages

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

LifePak Trace Elements

Key Features:

Highly bioavailable (utilized by the body)

Excellent tolerance

Complete spectrum at optimum amounts

LifePak TraceElements

Top Quality Sources (Amino Acid Chelates, Albion Labs, etc.)

Zinc AA Chelate Iron AA Chelate Copper AA Chelate Iodine (iodide) Vanadium (sulfate) Selenium (SeMet, selenite)

Chromium AA Chelate Manganese AA Chelate Molybdenum AA

Chelate Silicon (metasilicate) Boron (citrate)

LifePak Trace ElementsHighlights: Chromium (200 mcg):

• normal insulin and blood glucose levels

• 90 % of US diets may be low in chromium

• effective in non-insulin-dependent diabetes

Selenium (100 mcg):• essential cofactor for glutathione peroxidase, an

antioxidant enzyme

• may prevent prostate cancer

Chelates & Bioavailability

Bioavailability = the body’s ability to utilize a nutrient = absorption + tissue uptake + metabolic functions.

Amino acid chelates tend to have the highest bioavailability and solubility of all mineral forms.

Amino acid chelates are often better tolerated than inorganic mineral salts.

Chelates & Bioavailability

Chelates Amino Acid Chelates• Pseudo-chelates: mixtures of mineral salts and

hydrolyzed proteins; “proteinates” etc.

• LifePak: covalently-bound, fully reacted amino acid chelates (Albion Laboratories)

M O

O

NH2

H2N CH2

H2C

C=OO=C

LifePak Advantages

LifePak is FIVE formulas in one:1. high potency antioxidant formula

2. balanced B-vitamin formula

3. complete bone support formula

4. complete trace element supplement

5. phytonutrient formula

A.k.a. phytochemicals or secondary plant metabolites.

Non-essential plant compounds with health benefits.

Over 12,000 phytonutrients have been isolated from foods.

Phytonutrients

LifePak Phytonutrients

LifePak provides a broad spectrum of:

Carotenoids Flavonoids (Polyphenols)

LifePak Phytonutrients

Carotenoids: over 600 carotenoids present in nature safe vitamin A sources (a- & b-carotene) fat-soluble antioxidants (1O2 quenchers)

promote immune function (b-carotene) prevent prostate cancer (lycopene) prevent macular degeneration (lutein)

Phytonutrients

Beta-Carotene: Friend or Foe? high-dose (20-30 mg) synthetic beta-carotene

may promote existing lung tumors (ATBC study, CARET study).

Population studies: beta-carotene decreases risk for most cancers, incl. lung cancer.

Other carotenoids have been ignored in research. Most are more potent antioxidants.

Phytonutrients

Beta-Carotene: Friend or Foe?

Recommendations: Eat more fruits & vegetables! Pharmanex - IDN position:

Supplementation is beneficial: with a broad spectrum of dietary carotenoids at physiologic levels reflecting carotenoids from fruits & vegetables

LifePakPhytonutrients

LifePak Carotenoids:

beta-Carotene (D.salina) 6 mg (10,000 IU)

lutein (Marigold extract) 2 mg

lycopene (Tomato extract) 1 mg

alpha-Carotene 2 mg

Zeaxanthin

beta-Cryptoxanthin

(extracts conform to Pharmanex 6S Process)

O

LifePak Phytonutrients

Flavonoids: over 5,000 flavonoids

known in nature, 600 present in our diets. water/alcohol soluble plant products powerful antioxidants many enhance microcirculation (blood flow) many appear to prevent cancer

(epidemiological, animal studies)

LifePak Phytonutrients

LifePak Flavonoids (145 mg total): From 5 well-researched stdzd. extracts:

OPC from grape seed extract Hesperidin & Naringenin from citrus extract Quercetin Isoflavones (genistein, etc.) from soy extract Curcumin (polyphenols) from turmeric extract

Amount 5-10 servings of fruits & veggies All extracts conform to 6S Process

Synopsis: Health Benefits

LifePak: optimum supplementation for: addressing common nutrient deficiencies bone nutrition cardiovascular health glucose and insulin metabolism immune function

LifePak &Cardiovascular Health

Antioxidants: lower LDL-oxidizability

Calcium & Magnesium: maintain normal blood pressure & heart rhythm

B-Vitamins: maintain normal blood homocysteine

Flavonoids: promote normal platelet aggregation and blood microcirculation

LifePak &Insulin/Glucose Metabolism Vitamin C, 500 mg:

• promotes normal sorbitol metabolism

Vitamin E, 300 IU:• promotes normal platelet aggregation

• keeps protein glycosylation in balance

Chromium, 200 mcg:• essential for normal insulin function

LifePak & Immune Function

Promoting normal immune function Vitamins C & E:

• promotes cell-mediated specific and non-specific immunity

beta-Carotene, carotenoids:• promotes natural killer cell activity

Vitamin A, vitamin B6 & zinc:• essential for immune function

LifePak Women

LifePak Women

Young, Pre-Menopausal WomenKey Features: Bone Nutrition: 1,000 mg calcium & 500 mg

magnesium (2x LifePak!), & extra silicon;• National Insitutes of Health: 1,000 - 1,500 mg Ca/day

• About 80% of young women do not meet RDA (1,000 mg)

• FDA Health Claim: Calcium prevents osteoporosis

Extra Iron: 10 mg, amino acid chelate• iron deficiency is more common in young women; over 70%

do not meet RDA!

LifePak WomenKey Features, continued Folate and Inositol: For women in their child-

bearing years;• Folate prevents neural tube defects (FDA health claim)

Extra Vitamin B6: 20 mg• 65 % of women don’t meet the RDA for vitamin B6

Special Phytonutrients: • 25 mg soy isoflavones: same as in 25 grams soy protein

• gamma-linolenic acid-rich oils.

LifePak Prime

LifePak Prime

For Post-Menopausal Women & Men Over Age 40

Key Features: Bone Nutrition: 1,000 mg calcium & 500 mg

magnesium (2x LifePak!), & extra silicon• NIH: 1,000 - 1,500 mg calcium per day

Extra Zinc: 20 mg amino acid chelate• zinc promotes healthy immune function

• over 85% of the elderly do not meet the RDA

LifePak Prime

Key Features, continued: Glucosamine: 200 mg

• promotes joint structure & function

• 200 mg doubles average dietary intake

Special Antioxidants: glutathione, N-acetyl-cysteine, coenzyme Q10

Extra Phytonutrients: More curcumin, grape seed OPCs; added stdzd. Ginkgo extract and Milk Thistle extract.

LifePak PreNatal

LifePak PreNatal

For Pregnant & Lactating WomenKey Features: Optimum Antioxidants: 150 IU natural vitamin E &

300 mg buffered vitamin C• may prevent pre-eclampsia (gestational hypertension)• pre-eclampsia affects 5-15 % of pregnant women

Bone Nutrition: 650 mg Calcium & 350 mg Magnesium• pregnancy: fetal bone growth• lactation: milk production

LifePak PreNatalKey Features, continued: Folate and Inositol: 800 mcg, 500 mg

• prevent neural tube defects

Extra Iron: 30 mg, Amino Acid Chelate• best tolerated and most bioavailable form of iron• higher demands due to fetal blood & muscle formation• high risk for iron deficiency anemia

Chromium: 180 mcg, Amino Acid Chelate• promotes normal insulin and blood glucose metabolism• benefits in gestational diabetes mellitus

LifePak PreNatalKey Features, continued: Vitamin A: 5,000 IU is safe and effective

• Supplementation with more than 10,000 IU of preformed vitamin A may increase the risk for fetal damage (teratogenic effects).

Carotenoids: Natural beta-carotene (5,000 IU), alpha-carotene, lutein & lycopene.

LifePak TeenTM

Optimum Supplementation for 9-18 year olds

THE PROBLEM:

Over 60% of teen boys and over 80% of girls don’t meet the RDA for calcium or magnesium*

*USDA CSFII 1994-96 Survey Data

THE SOLUTION:

LifePak TeenBone Nutrients:500 mg Calcium200 mg Magnesium400 IU Vitamin D40 mcg Vitamin K3 mg Boron3 mg Silicon

THE SOLUTION:

LifePak TeenAntioxidants5,000 IU Vitamin A3 mg -carotene100 IU Vitamin E 200 mg Vitamin C70 mcg Selenium

THE PROBLEM:

Not enough antioxidant vitamins: Over 60% of teens don’t get the RDA for vitamins A & E*

*USDA CSFII 1994-96 Survey Data

THE PROBLEM:

Not enough iron: 72.5% of girls ages 12-19 don’t meet the RDA for iron*

*USDA CSFII 1994-96 Survey Data

THE SOLUTION:

LifePak Teen9 mg iron as amino acid chelate;50% of Daily Value

THE PROBLEM:

Not enough zinc: Over 65% of teens don’t meet the RDA for zinc*

*USDA CSFII 1994-96 Survey Data

THE SOLUTION:

LifePak Teen15 mg zinc as amino acid chelate;100% of Daily Value

LifePak Safety

All vitamin & mineral levels are below the NOAEL (No Observed Adverse Effect Level) established by the CRN (Council for Responsible Nutrition, 1998).

Phytonutrients are added at levels that are documented safe.

Clinical studies showed no adverse effects to LifePak

LifePak Directions

One packet twice daily with meals• meals enhance absorption (vitamins) and

improve tolerance (minerals)

• twice daily promotes steady nutrient delivery, e.g., plasma levels of vitamin B6:

7:30 AM 6:30 PM

LifePak Precautions

“Pregnant & lactating women, diabetics, hypoglycemics, and people with known medical conditions should consult with a physician before taking supplements”

LifePak Substantiation

Over 1,000 peer-reviewed scientific papers on file documenting the efficacy and safety of all nutrients in LifePak.

LifePak Substantiation

No other complete multi-nutrient supplement has ever been subjected to two well-designed double-blind clinical studies to show antioxidant effects in healthy people.

In other words...

LifePak is the best multivitamin/mineral

supplement -- worldwide!