module 1 intro to leap - 9-14

Module 1: Introduction to LEAP Module 1: Introduction to LEAP A Highly EffectiveA Highly Effective

Dietary Management Program forDietary Management Program forImproving Outcomes inImproving Outcomes in

IBS, Migraine & FibromyalgiaIBS, Migraine & Fibromyalgia

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Module 1: Intro to LEAP/OxfordModule 2: Intro to Adverse Food ReactionsModule 3: Diagnostic Testing For Adverse Food Reactions Module 4: Irritable Bowel SyndromeModule 5: Migraine Headaches/FibromyalgiaModule 6: Dietary TrainingModule 7: Building Your Practice With LEAPModule 8: Enrollment, Payment, Insurance,

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LEAP Training LEAP Training Outline:Outline:

Introduce the key concepts related to LEAP

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Learning ObjectivesLearning ObjectivesIntroduction to Introduction to LEAP/Oxford:LEAP/Oxford:

List the key members of the Oxford Medical Advisory Board

List the key credentials of Oxford Biomedical Technologies, Inc.

WHAT WHAT CAUSESCAUSES IBS & MIGRAINE SYMPTOMS? IBS & MIGRAINE SYMPTOMS? In Many Cases: In Many Cases: FOOD INTOLERANCEFOOD INTOLERANCEPage 1051, MERCK MANUAL of Diagnosis and Therapy:

"Recently Food Intolerance was found to be responsible for symptoms of some patients* with the IRRITABLE BOWEL SYNDROME, confirmed by double-blind food challenge. An increase in

rectal prostaglandin levels was noted when a reaction occurred .”

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Allergy 1995; 50 (20 Suppl): 78-81“Mechanisms in Adverse Reactions to Food: The Brain.” Anderson JA.

Division of Allergy & Clinical ImmunologyHenry Ford Hospital, Detroit, Michigan, USA

Specific chemical mediator release such as histamine and the prostaglandins (PG2a or PGD2) associated with headaches has been found in a few patients who were repeatedly challenged

with specific foods, using Double blind Placebo Controlled Food Challenge techniques.

Headache. 1998 June;38(6):465-7“Cytokines and Migraine: Increase of IL-5 and IL-4 Plasma Levels”

Munno I, Centonze V, Marinaro M, Bassi A, Lacedra G, et al

“…we observed a strong increase of IL-5 levels in 84.3% as well as increased IL-4 levels in 37.5% of patients with migraine without aura. These results…may support the growing

arguments of an immunoallergic mechanism in the pathophysiology of migraine.”

Histamine Serotonin Prostaglandin

s Leukotreines

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Foods and Food Additives Trigger Non-Foods and Food Additives Trigger Non-ALLERGIC (Non-IgE Mediated) Immune ALLERGIC (Non-IgE Mediated) Immune Reaction Causing Mediator Release by Reaction Causing Mediator Release by Associated Leukocytes. Associated Leukocytes.

This in Turn Leads to physiologic effects of released proinflammatory and proalgesic mediators:

IBS:Inflammation, Smooth Muscle Contraction, Diarrhea, Pain, Cramping, and Visceral Hypersensitivity

Migraine:Changes in blood flow (vasoconstriction or vasodilation), inflammation, WBC activation, pain receptor activation leading to severe headache.

Cytokines Dopamine Peroxidase Many more

IDENTIFYINGReactive Foods & Chemicals

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The Biggest Problem Concerning The Biggest Problem Concerning Non-IgE Mediated Immunologic Non-IgE Mediated Immunologic

Food SensitivitiesFood Sensitivities

•Delayed Reactions•Dosage Dependent•Patient Specific• Many Reactive Foods & Chemicals

Quantify the Common End-Point of ANY Cellular Reaction with the

Patented Mediator Release Test (MRT)

Mediator Release is the Direct Cause of Symptom Manifestation in Immune Mediated Food & Chemical Sensitivities•Histamine•Prostaglandins•Serotonin•Cytokines

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How Do You Isolate Which Foods Or Additives How Do You Isolate Which Foods Or Additives Provoke These Reactions?Provoke These Reactions?

B efo re R ea ctio n A fter R ea ctio n

Reactive Moderately Reactive Non-ReactiveMRT Test Reaction Levels

carrotasparagusbeetcucumbereggplantgreen peppermushroomonionyellow squashpumpkinspinachcauliflowercelerystring beanbroccolicabbagesweet potatotomatowhite potatolettucezucchini

Vegetables Reaction Level

Digestive Diseases 2001; 19 (30): 244-40 Update In The Therapeutic Update In The Therapeutic

Management of Irritable Bowel Management of Irritable Bowel SyndromeSyndrome

…It is not likely that one single treatment will help every IBS patient. Many of them will need a more complex approach, with multidisciplinary therapy including:

1. Dietary Modification2. “Psychotherapeutics”3. Medication “PRN”

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Elements of the LEAP Elements of the LEAP Dietary Management Dietary Management

Program for IBSProgram for IBS

LEAP Includes ALL the elements Recommended in TheCurrent Literature for IBS Disease Management:

1. Highly Patient Specific Dietary Modification Plan, based on patient-specific food or chemical response

2. Patient Self Directed Stress and Anxiety Reduction Therapy Program on Compact Disc (see Authors)

3. Pharmacotherapy is reduced or eliminated.4. Tools for Patient Selection and Outcome

Assessment

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"As a Board Certified Family Physician operating a busy family practice , I commonly run across Migraine and Irritable Bowel Syndrome . I was introduced to the LEAP Disease Management Program approximately 1-1/2 years ago and have been very pleased with the results. Roughly 50% of the patients I've put on the LEAP Program report tremendous improvement in their chief complaint and global symptoms. Another 25% report noticeable benefits. I have a special interest in therapies targeted towards migraine because I too am a long time migraine sufferer. In addition to helping my patients, LEAP has also identified my own trigger foods and food additives, helping to decrease the frequency and intensity of my own migraines. I highly recommend the LEAP Program to any physicians concerned with improving outcomes for their IBS and Migraine patients."

Jeffrey F. Klein, M .D., F.A.A.F.P.Westlake Village, CAAssociate Clinical Professor of Family MedicineUCLA School of Medicine

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LEAP Affiliate Physician Experiences…LEAP Affiliate Physician Experiences…

“We have been using the LEAP Program for well over a year now and have had phenomenal results. Our most impressive results have been with irritable bowel syndrome and Migraine, though we have had very impressive results as well with other conditions such as fibromyalgia, depression, and gastroesophageal reflux disease….Overall our experience has been a tremendous success and I would highly recommend it to any physician who deals with any of these problems."

W. Brad Wilson, M.D.Internal Medicine

LEAP Is Easily Integrated LEAP Is Easily Integrated Into A Dietitian’s Practice Into A Dietitian’s Practice

1. Market To Current Referral Sources2. Initial Consult

1. Nominal fee2. Designed to build motivation & commitment

3. Verify Insurance Coverage (Free Service) if Applicable

4. Blood Draw1. Can usually be done at referring physician’s

office5. Schedule Patient to Get Results 10 – 14 days after

Blood Draw6. Dietitian Works with Patient7. Outcomes Periodically Reported to Referral

Physician 09-14 11

What Can Patients

Expect On The LEAP

Program?

RESULTS!!!09-14 12

What LEAP What LEAP Patients Say…Patients Say…

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Last September, before I started the LEAP Program, my stomach was a mess! I had diarrhea for over 40 consecutive days, sometimes up to 13 times in one day. I had a constant bloated feeling. I consumed Zantec (150 mg) and over-the-counter medicines to no avail. My doctor could not get me under control, and proposed all sorts of intrusive testing.

I couldn’t believe the claim your people made that taking me off certain foods (in my case wheat and onions) would help my problems. But what a difference the LEAP Program has done for me. Only ONE instance of diarrhea in the three months I’ve been on the Program (I learned that I can’t drink cola with ice). No medicines! No bloatedness! And I’ve lost 9 pounds as a bonus!

You have been most helpful to me in getting “with the program” and paying attention to the labels. I’m on many new and different foods, and food preparation and shopping can be a pain, but the results have made a new person out of me. Ask my husband!

Best regards,Elaine DavisHollywood, Florida


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I chose the LEAP Program hoping to get some sort of relief from my digestive problems and chronic diarrhea. My condition had gradually worsened over the past year and had become very uncomfortable and humiliating for me. I was surprised when after only 4 days on the LEAP Program I started to feel results. Eliminating harmful foods from my body has made me feel like a new person. I now have normal bowel movements, no bloating, lower blood pressure, a truly great sense of well being and new found energy! The LEAP Program really works!!

Karen Baird


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Dear Drs. Nolen and Male,

It has been almost 5 months since I have been on the LEAP ImmunoCalm Diet…Before I started the diet, I had severe digestive disturbances, constant headaches, weight imbalances, food cravings, coughing, mood swings, unable to sleep at times. I am happy to report that all of these symptoms are gone since about the 10th day of the diet. I have lost 6 lbs. I cook everything from scratch now, strictly adhere to the diet and feel so much healthier. Please continue to use this method of treatment on others with these problems. It has been a life saver for me. I thank you from the bottom of my heart.

Gladys Hunting

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What Can Dietitians What Can Dietitians Expect By Using Expect By Using

LEAP in Their LEAP in Their Practice?Practice?

Improved Clinical Outcomes

New Patient ReferralsEnhanced RevenueFull Product Support

RevenueRevenue OpportunitiesOpportunitiesFor DietitiansFor Dietitians

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Initial Consult $25-$50Test Markup $150Follow-up Consults $300

5 new LEAP patients per week @ $475/patient= $2375 per week

= $123,500 per year additional revenue

Why LEAP?Why LEAP?

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Because LEAP is Win–Win–Win • Patient Gets More Effective Treatment

• Physician Has An Appropriately Targeted Treatment Option That Doesn’t Take His Time Or Resources

•Dietitian Has Access to a New and Substantial Market of Motivated Patients, and Can Earn Significant Revenue.

Oxford Biomedical Oxford Biomedical Technologies, Inc.Technologies, Inc.

• Federally & State of Florida Licensed Medical Reference Laboratory

• Founded in 1993• Developed LEAP in Research and Development

Clinics from 1996 to 2001• Patented MRT• Member of Disease Management Association

of America

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Medical Advisory Medical Advisory BoardBoard

Jonathan Brostoff, MD, MA, DM, DSc(med), FRCP, FRCPath Position:Principal International Consultant in Immunology and AllergologySelected Vitae:Professor Emeritus of Allergy and Environmental HealthKing’s College School of Medicine, London Council Member, British Society for Allergy and Clinical ImmunologyCouncil Member and Past President, Clinical Immunology and Allergy Section, Royal Society of

MedicineCommittee Member, British Society for ImmunologyEuropean Academy of Allergy and Clinical Immunology, Committee on Adverse Reactions to Foods,

Committee on Standardization of In Vitro Tests for AllergyMedical Advisor, United Kingdom Ministry of Agriculture, Food and Fisheries For Food and Chemical

Sensitivity

Editorial Boards:Clinical Reviews in Allergy; Clinics in Allergy and Immunology; Perspectives in ENT ImmunologyCurrent Opinion in Immunology; Clinical Immunotherapeutics

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Jeffrey F. Klein, MDMedical Director, Crossroads in HealthPrivate Family PracticeWestlake Village, CaliforniaGraduate: UCLA School of Medicine Position:Principal Consultant, Family Practice, Allopathic Medicine Selected Vitae:Assistant Clinical Professor of MedicineUCLA School of Medicine Fellow, American Academy of Family PhysiciansAdvisory Board, Ventura County Regional Occupational ProgramFormer Physician Advisor, Medical Department/Utilization Review Blue Cross of CaliforniaPharmacy and Infection Control Committee, Los Robles Medical CenterFormer Member, Board of Directors, California Academy of Family PhysiciansEditor, Drug and Disease Digest, Community Medical GroupFormer Delegate, A.A.F.P. Congress of Delegates

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William T. Kniker, M.D.Private Allergy PracticeAllergy, Asthma & Immunology Associates of South Texas, P.A.San Antonio, TexasGraduate: University of Texas

Position:Principal U.S. Consultant, Allergy & Immunology, Adverse Reactions to Foods

Selected Vitae:Adjunct Professor of Environmental Sciences, University of Texas School of Public HealthMember of Board of Directors, Autism Treatment Centers of TexasPresident, San Antonio Allergy SocietyVice-President, San Antonio Allergy SocietySecretary Treasurer, San Antonio Allergy SocietyMember of Chancellor’s Council of the University of Texas SystemVice-President and Board Member American In-Vitro Allergy/Immunology SocietyBella Schick Lectureship and Award, American College of AllergistsPresident, San Antonio Pediatric SocietyFellow Distinguished Award, American College of AllergistsMu Delta Award, University of Texas Medical BranchOutstanding Resident AwardValedictorian, University of Texas Medical Branch

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William T. Kniker, M.D. Continued American College of Allergy, Asthma, and ImmunologyChairperson of Adverse Reactions to Foods Committee, now a regular memberContributing Editor, Annals of AllergyCo-Chairman Literature Review CommitteeMember, Editorial Board & Publications Committee Annals of AllergyMember of the International Literature Review CommitteeChairman of the International Food Allergy Symposium CommitteeCo-editor of Journal Club Allergy/Immunology: monthly feature of Annuals of AllergyChairman of the Training Director’s CommitteeMember of the Scientific & Educational CouncilMember of the annuals of Allergy Liaison CommitteeMember of the Food Allergy CommitteeMember International Food Allergy Symposium Committee

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Jeffrey D. Rettig, DOPrivate Practice Primary Care, Rural Health PracticeGroesbeck, TexasGraduate: Kirksville College Osteopathic Medicine Position:Principal Consultant, Osteopathic Medicine

Selected Vitae:Faculty, University of North Texas, Health Science Center, Ft. Worth, TexasChief of Staff, Parkview Regional HospitalCounty Health Officer, Limestone County, TexasMedical Director, Spring Seasons Nursing HomeMedical Director, Windsor Manor Nursing Home

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Fred H. Williams, MDPrivate PracticeGateway GastroenterologySt. Louis, MissouriGraduate: Johns Hopkins University School of Medicine

Position:Principal Consulant, GastroenterologyMedical Director, LEAP HomeCare Program

Selected Vitae:Former Asst. Chairman, Dept. Of Gastroenterology, Wilford Hall USAF Medical Center, Lackland AFB, TexasFormer Asst. Professor of Medicine, Medical University of South Carolina, Charleston, South CarolinaFormer Assistant Professor of Medicine, University of Texas, San Antonio, San Antonio, TexasFormer Assistant Professor of Medicine, Uniformed Services University of Health Sciences, Bethesda, Maryland

Memberships:American College of Gastroenterology, American Gastroenterology Association, American Society of

Gastrointestinal Endoscopy, American Association for the Study of Liver Diseases

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Concluding Concluding RemarksRemarks

module 1 intro to leap - 9-14

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