EDiT 1.0 N

2011

PHYSICIANS'DESK

REFERENCE®CEO: Edward Fotsch. MD

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i26®(polyvalent hyperim~u~e egg)Dietary Supplement_ r

Hyperimmune E~ (HIE) Powder -

DESCRIPTION

i26 (polyvalent: "hyperimmuiio" egg) is whole egg pro-tein(HIE).l Along with· the generation of specific antibodies,

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Complimentary CME for PDR-listed products at PDR.net

increased levels of bioactive ·molecules are produced.2,3 Invitro, in vivo, and human trials, suggest that the naturally-occuiring immune components in hyperimmune egg are uti-lized by the body to help it achieve immune homeostasis.The biological factors in i26 help the body maintain immunehomeostasis by partnering to help it modulate immunolog-ical responses, especially those of an autoimmune orinflammatory nature.BACKGROUNDUpon oral administration of hyperimmune egg, a widerange of immune components, both of a specific and non-specific nature, are passively transferred to the recipient.Although the intact immunoglobulins are confined to the lu-men, other smaller, bioactive immune components maywork systemically. This may occur: a) indirectly by activa-ting cells in the GALT which then migrate with the appro-priate message, or b) by directly crossing the GI barrier andcirculating throughout the body to help it appropriatelymodulate immunological reactions.STUDIESJoint Comfort and Flexibility •.An open-label clinical trial conducted at The Hospital forSpecial Surgery in New York, NYC, demonstrated that thedaily consumption of 4.5g of HIE resulted in statisticallysignificant changes in the daily aches and discomfort asso-ciated with daily life.4 Combining hyperimmune egg withcertain forms of glucosamine-HCI results in a synergisticjoint support effect.5Circulatory and Cardiovascular HealthHyperimmune egg has been demonstrated to help the bodycontrol several key indices of cardiovascular health both invivo, and in a double-blind, placebo-controlled humantrial.6,7Gastrointestinal HealthAdministration of hyperimmune egg significantly helps thebody support healthy digestive function 8 and intestinaltransit.9 It also appears to help maintain overall health ofthe gastrointestinallining.10, 11Maintaining Healthy Weight in Populations At RiskHyperimmune egg helps maintain or increase lean musclemass in individuals experiencing involuntary weightchanges.Iz-l-tQuality of Life

~ Subjects with poor quality of life, that consumeds.Og ofhy-perimrmine egg showed marked: changes in energy, weight,appetite, sleep quality, gastrointestinal and pulmonaryareas as well as blood counts.12-14Enhanced Athletic Performance, Stamina, RecoveryIn a randomized, double-blind, placebo-controlled univer-sity trial, subjects utilizing 13.5g daily of hyperimmune eggexperienced greater athletic performance as measured byendurance, recovery and strength. Hyperimmune egg altpeared to help the body lower intrinsic heart rates, andstimulate muscle growth and repair resulting in better per-formance. Subjects reported higher levels of both anaerobicand aerobic performance, with less effort when usinghyperimmune egg.15,16 Professional athletes report similarfindings.

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INDICATIONS AND USAGE

i26 is defined under the Dietary Supplements Health andEducation Act (DSHEA) as a dietary supplement and assuch is not intended to diagnose, prevent, treat, or cure dis-ease. ~ independent panel of experts has conferred self-affirmed GRAS ("generally recognized as safe") status tohyp,erimmune .egg. The FDA has issued a Food Master FileNumber for this ingredient -,Statements as to function have not been evaluated by theFood and Drug Administration but the following structurefunction claims for i26 have been submitted to the Agency:Balances and supports the immune systemHelps the body maintain:digestive tract healthflexible and healthy jointshealthy levels of cholesterolcardiovascular function and healthy circulatory systems

Helps increase energy levelsHelps enhance a sense of well-beingNote: Hyperimmune egg may be used concomitantly withprescription medications. '

every few days until desired serving is achieved. Diabeticsmay wish to monitor their blood glucose levels more fre- ~quently while introducing hyperimmune egg into their di-ets, since some individuals appear to reach glucose homeo-stasis rapidly as they start to approach:' immunehomeostasis.

CONTRAINDICATION

Hyperimmune egg is contraindicated in individuals with ahistory of extreme hypersensitivity or life-threatening al-lergy to orally administered egg.

PRECAUTIONS

Although reactions are rare, it is prudent for individualswith "sensitive" .digestive, systems to introducehyperimmune egg gradually. Start with 0.5g (118 of a scoop)of i26/day for 3-4 days successively and double the amount

ADVERSE REACTIONSAdverse reactions rarely occur. In two randomized double-blind, placebo-controlled trials (one with the US Military,the other at a University) the hyperimmune egg was well-tolerated. There was 82% compliance in a Us Military studyand 100% compliance in the University study.

ADMINISTRATIONRecommended servings are 4.5g-9g1daily for maintenance,more as desired. Some of the larger l)ioactive immune com-ponents in hyperimmune egg are heat-labile, but other thanhigh temperature foods or beverages, InE can be added toalmost all other foods or beverages (e.g., puddings, yogurts,salads, juices, ice cream, etc.).The eqnivalent of one serving (4.5g) ofhyperimmune egg isfound in: one scoop of i26, 9 capsules, 3 Chewables, 1. scoopof i26 COMPLEl'E Support, or 2 scoops of i26 FIT.

HOW SUPPLIED• i26 - pure hyperimmune egg powder (31 sei:vings)• i26 Capsules - pure hyperimmune egg in capsules (1.5servings) J

• i26 Chewables- hyperimmune egg in flavored tablets(vanilla, banana) (15 servings)

• i26 COMPLETE Support - hyperimmune egg with vita-mins and minerals (chocolate, strawberry, vanilla) (31servings) [to be reconstituted with liqnid]

• i26 FIT - hyperimmune egg with protein, fiber, vitaminsand minerals (15 servings)[to be reconstituted with liquid, preferably skiin milk]

Stability and StorageStore in a dry cool location with the lid tightly shut.

REFERENCES1 Hens are stimulated multiple times with more than 26whole inactivated bacteria of human interest including Sal-monella, Staphylococcus, Streptococcus, Escherichia coli,Klebsiella pneumoniae, Pseudomonas, Proteus, Propioni-bacterium acnes, and Hemophilus influenzae.2 US Patent # 6,420,337 Highly purified cytokine activat-ing factor and methods of use ..3 US Patent # 7,083,809 Purified cytokine inhibitory factor4 Greenblatt HC Adalsteinsson 0 & LKagen, Administra-tion to Arthritis Patients of a Dietary Supplement Contain-ing Immune Egg: An Open-Label Pilot Study, 1998.J MedFood 1:1715 US Patent # 6,706,267 Glucosamine and egg for reducinginflammation6 Wilborn WH Effect of Immune Egg Protein on SerumCholesterol in Rabbits on Atherogenic Diets 1997 unpub-~ed • r7 Karge WH et al. Pilot Study on the effect of Hyperim-mune Egg Protein on Elevated Cholesterol Levels and Car-diovascular Risk Factors 1999 J Med Food 2:518 Morningstar MW Hyperimmune Egg Powder For TheTreatment Of Irritable Bowel Syndrome: A Case Series 2004J .Chircpr Med 3:12-49 Jacoby, ill Moore G and G Wnorowski Inhibition of'Diar-rhea by Immune Egg: A Castor Oil Mouse Model J NutrFunct 2001 Med Foods 3:4710 US Patent # 6,803,035 Anti-diarrheal and method forusing the same .11 US Patent # 5,772,999 Method of Preventing, Counter-ing or Reducing NSAID-Induced Gastrointestinal Damageby Administering Milk or Egg Products from Hyperimmu-nized Animals12 Ambekar R Chungi V Hyperimmune Egg: Its Ability toMaintain Weight and Lean Muscle Mass in Individuals withCachexia 1998 unpublished13 Okullo J An Assessment of Effectiveness and Acceptabil-ity ofimmune26 in the Management of the Sick in Uganda2002 unpublished14 Kizito FB Improvements in Quality of Life for HNIAIDSPatients Using Hyperimmune Egg (Immune 26™) - TheTASO Study 3rd Inter AIDS Soc Conf HIV Pathogenesisand Treatment 2005 Abstract No. MoPe11.2C4315 Scheett TM, et al. Hyperimmune Egg Protein DecreasesSubmaximal Heart Rate and Increases Peak Power 2007Med Sci Sports Med Exerc 39:S36516 Scheett TM, et al. Increased Muscular Strength and En-hanced Muscle Repair with Hyperimmune Egg Protein Sup-plementation 2007 J Strength Cond Res 21:e41

Shown in Product Identification Guide, page 310

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