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The Story of Kamut Pasta

 

History and information about this great grain, from the Kamut Association of North America.

History of Kamut®
Nutrition Analysis
Physician Recommendations

 

pict kamut
Assessment of Allergenic Reactivity of Kamut® Versus Common Wheat

International Food Allergy Association

822 South Maple Avenue, Suite 101
Oak Park, Illinois 60304
(708) 386-9090
FAX (708) 386-9097

CLINICAL TRIAL STUDIES



OCTOBER 11, 1991



BY

EILEEN RHUDE YODER, Ph.D.
PRESIDENT
INTERNATIONAL FOOD ALLERGY ASSOCIATION

ABSTRACT: A clinical study to measure the allergenic reactivity of wheat-sensitive individuals to Kamut versus common wheat using Double Blind Placebo Controlled Food Challenges (DBPCFC) and other clinically derived immune parameters.

RESEARCH PERSONNEL: Eileen Rhude Yoder, Ph.D., Team Leader and Author, Food Allergy Specialist, ; Anne Spzindor Watson, M.D., Board Certified Allergist, Cindy Dubanowich, Food Allergy Technician,; Gary Kitos, Ph.D., Laboratory director, Allergy Testing Laboratories.

ABBREVIATIONS: (DBPCFC) Douple Blind Placebo Controlled Food Challenges


INTRODUCTION

        Recently, there has been renewed interest in the new “ancient” grains to see if there is enough of a biological difference in these grains to allow them to be tolerated by wheat-sensitive individuals. Different ancient grains (amaranth, quinoa, spelt and Kamut) were reviewed to see if any would be a good substitute for common wheat.

        Based on a survey of food allergy patients in our practice, Kamut appeared to cause the least allergenic reactions in wheat-sensitive individuals (possibly due to its recent introduction in the America diet). In addition, Kamut (Triticum polonium) is slightly different taxonomically from common wheat (Triticum sativum); therefore Kamut was chosen for this study.

        Two studies were undertaken. The first preliminary study was conducted to determine if Kamut is different enough biologically from common wheat so that it may be tolerated by wheat-sensitive individuals.

        Randomly chosen food allergy patients had RAST IgG tests done to both common wheat and Kamut. Tests which indicated negatives to both common wheat and Kamut or which had equal test scores were rejected. Reports of one hundred patients with a positive test score to common wheat and/or Kamut were then evaluated. Seventy IgG RAST tests indicated higher test scores to common wheat than Kamut.

        Based on these results, a second study was conducted. A small number of patients were chosen with positive tests (RAST and/or Skin Tests) indicating a possible wheat allergy. Stage One of the second study included oral food challenges to common wheat on these patients. Ten patients with moderate positive reaction to common wheat were then chosen for Stage Two (DBPCFC to Kamut).

        The overall objective of this study was to evaluate the acceptability of Kamut in wheat-sensitive individuals. Specifically, IgG4 antibodies were measured in a group of children and adults with food allergy involving the skin, respiratory tract and the gastrointestinal tract. These findings were correlated with history, skin testing and the results of double-blind oral food challenge(s).


PATENT SELECTION AND INCLUSION CRITERIA

        The study population consisted of 20 children and adults ranging from 5 to 54 years of age who had clinical symptoms of wheat allergy. Clinical symptoms included the following organ systems: (1) dermatologic: itching and burning of skin; (2) respiratory tract; asthma, hacking cough, tightness in chest, sneezing, rhinorrhea, wheezing; (3) gastrointestinal tract: diarrhea, indigestion, nausea, abdominal cramps; (4) ophthalmic: allergic shiners, blurred vision; (5) otologic; dizziness, pain and pressure in ears; (6) cardiovascular; tachycardia,; (7) muscular: muscle spasms, pains in joints; (8) urological; frequent urination; (9) psychological: depression, severe fatigue, mental confusion; and (10) neurological: headaches including a migraine.

Shown below are the inclusion criteria for the study.

Age: 5 to 55
Sex: male or female
Refrain from Hisminal for three months
Refrain from other anti histamines, corticosteroid or sodium cromolyn for 3 days prior to food challenges and skin tests
a positive immunological test score to wheat (either by skin test, RAST tests or well documented food diaries
No history of anaphylactic shock
Specific exclusions: other diseases or condition, pregnant females, or long-term steroids
No infection for last four weeks

CLINICAL TRIAL DESIGN

STUDY ONE


Comparative Study of Wheat and Kamut IgG RAST

        A preliminary study was conducted to determine if Kamut is different enough biologically from common wheat so it may be tolerated by wheat-sensitive individuals.

        One hundred and thirty-two randomly chosen food allergy patients had RAST IgG tests done to both common wheat and Kamut. The choice of RAST IgG were twofold. First, most food reactions are of a delayed nature (90% of all food allergies are of a delayed response as compared to 10% for immediate reactions). Second, patients did not have to stop any medications to have the RAST blood test done. With skin tests, patients have to stop antihistamines for at least three days prior to the testing.
        Of these, 32 had either negative or equal scores to common wheat and /or Kamut. One hundred had a positive score to either or both wheat and Kamut. Seventy IgG RAST tests indicated higher test scores to common wheat than Kamut.

        On the average, wheat test scores indicated a higher average score as compared to Kamut. Of these, 70 tests had higher wheat scores than Kamut, 30 had higher scores to Kamut than wheat. The average mean of common wheat was 2.5 with Kamut being 1.9 with a range 0.0 to 6+. See Tables below.

Table 1. 100 RAST IgG wheat and Kamut Scores

NO. KAMUT WHEAT VALUE   NO. KAMUT WHEAT VALUE
001 2.0 2.1 +.01   050 3.0 1.0 -2.0
002 1.0 0.0 -1.0   051 3.5 1.5 -2.0
003 3.3 1.6 -1.7   052 1.8 1.1 -0.7
004 2.1 2.4 +0.3   053 1.2 1.1 -0.1
005 4.4 5.8 +1.4   054 1.2 0.0 -1.2
006 1.1 0.0 -1.1   055 0.0 1.3 +1.3
007 2.5 1.3 -1.2   056 1.9 0.0 -1.9
008 1.7 3.0 +1.3   057 4.5 5.5 +1.0
009 1.4 1.0 -0.4   058 1.1 2.4 +1.3
010 1.8 3.5 +1.7   059 0.0 2.0 +2.0
011 0.0 1.2 +1.2   060 2.2 3.0 +0.8
012 2.3 3.8 +1.5   061 2.9 4.0 +1.1
013 2.1 2.0 -0.1   062 3.4 3.0 -0.4
014 2.8 3.0 +0.2   063 0.0 2.0 +2.0
015 1.4 2.0 +0.6   064 1.1 2.1 +1.0
016 3.8 5.4 +1.6   065 2.8 4.2 +1.4
017 3.3 5.7 +2.4   066 1.2 1.3 +0.1
018 1.2 2.1 +0.9   067 1.5 4.5 +3.0
019 3.2 4.4 +1.1   068 0.0 3.4 +3.4
020 0.0 1.1 +1.5   069 0.0 1.2 +1.2
021 4.6 5.4 +1.6   070 5.3 6+ +0.7
022 2.4 3.8 +2.1   071 1.3 4.2 +2.9
023 0.0 2.0 +0.9   072 0.0 1.3 +1.3
024 5.1 6+ +1.3   073 1.6 1.7 +0.1
025 2.0 3.1 +1.0   074 0.0 1.0 +1.0
026 0.5 0.0 -2.0   075 3.3 3.4 +0.1
027 1.2 2.8 +1.0   076 1.4 1.1 -0.3
028 2.1 4.2 +0.7   077 1.2 1.6 +0.4
029 3.5 4.4 +0.4   078 2.5 2.0 -0.5
030 0.0 1.3 +1.2   079 2.5 1.4 -1.1
031 0.0 1.0 +1.5   080 2.0. 5.2 +3.2
032 0.0 2.0 +0.7   081 2.6 3.6 +1.0
033 0.0 1.0 +1.0   082 2.5 2.0 -0.5
034 1.2 1.9 +1.7   083 0.0 2.4 +2.4
035 2.8 2.4 -0.6   084 2.8 4.6 +1.8
036 1.2 0.0 -1.2   085 1.1 4.2 +3.1
037 1.3 2.8 +1.5   086 0.0 2.5 +2.5
038 2.8 3.5 +0.7   087 3.2 4.4 +1.2
039 1.0 0.0 -1.0   088 0.0 1.6 +1.6
040 2.5 4.2 +1.7   089 0.0 1.4 +1.4
041 1.8 2.4 +0.6   090 2.5 2.5 +1.0
042 0.0 2.0 +2.0   091 1.4 0.0 -1.4
043 3.5 3.1 -0.4   092 2.7 3.5 +0.8
044 2.0 0.0 -2.0   093 0.0 1.2 +1.2
045 2.2 1.3 -0.9   094 2.2 0.0 -2.2
046 1.1 0.0 -1.1   095 5.2 6+ +0.8
047 4.5 4.0 -0.5   096 2.4 3.0 +0.6
048 2.0 3.0 +1.0   097 3.7 3.9 +0.2
049 1.1 0.0 -1.1   098 0.0 4.4 +4.4
          100 4.5 5.5 +1.0
Mean 1.9 2.5 +0.6          

Table 2. Average Scores of wheat and Kamut Rast Tests

  Wheat Kamut
Total Rast Scores 249.2 185.0
Average Mean 2.5 1.9
Total Positives 70 30

Table 3. Total Differences in Wheat and Kamut Rast Tests

  Wheat Kamut Total
Total Difference in score 249.2 185.0 +64.2
Lowest score 0.0 0.0  
Highest score 6+ 5.3  



Techniques of Immune Analysis Used

        The radioallergosorbent test (RAST) was used as the primary immune clinical test. The RAST is an in-vitro assay and offers a means of measuring a patient’s circulating antigen-specific IgG with no risk to the patient. The findings of these antibodies has been shown to correlate in general with clinical sensitivity. (5)

        In addition, IgE skin testing or RAST (IgG and/or IgE for wheat was done on all patients.

        Dr. Gary Kitos oversaw all the laboratory tests and prepared the necessary samples of Kamut for the RAST tests. Blood serum from two patients were used as the positive and negative controls for the RAST test. One patient, who had a very serious reaction to Kamut was used as the positive control and a second patient, who has been eating Kamut for over a year, was used as the negative control.

Materials and Methods

        Shown in Figure 1 is a schematic representation of the experimental design of the second study. Preliminary screening of all subjects consisted of a physical, history, skin testing, and in vitro tests to identify potential subjects for the study. Twenty patients with known wheat food allergies were recruited from among patients attending our allergy clinic. All the patients studied had a clinical history of allergy and/or asthma, positive reactions (Skin test and/or RAST test) to wheat and meet all the required criteria. Patients allergic to pollens were studied outside the ragweed season. They were selected over a period of six months. Since all of the patients have multiple food allergies, they did not know which food was being challenged. The most common foods and chemicals challenged at the office included milk, egg, wheat, corn, soy, tartarzine, mono-sodium glutamate and sulfites.

        If the subject met the entrance criteria they were then given an elimination diet for 2 weeks or more which was free of wheat and any known or suspected food allergen to allow clearing of the allergen and to be symptom-free. In most cases, patients have avoided wheat from one month to a year. To protect all patients who may experience anaphylactic shock, all DBPCFC were done at our office. They were also expected to keep a food diary during this time. A detailed explanation of all the risks involved in this study was presented to the patient also with a consent form acknowledging the dangers of a food challenge. A release of information form was signed by the patient.

        Each individual was clinically monitored on a continuous basis during all food challenges. Patients were also seen at specific intervals throughout the study to observe for any delayed reactions.

        Of the twenty patients, ten were excluded from the study because they (a) did not elicit any symptoms to wheat during the wheat challenge, or (b) they had such a severe reaction to wheat that they refused to continue with the study. The remaining ten patients had moderate reactions, chose to eliminate wheat from their diet have an oral challenge to Kamut. The patients, however, did not know when a placebo or Kamut was being challenged.

RESULTS

Table 4 indicates the type of diagnosis used for wheat and their reactions to both the common wheat and Kamut challenges. Overall, seven patients (70%) were able to tolerate Kamut.

Table 4. Comparative Reactions Between Wheat and Kamut Food Challenges among 10 patients

DIAGNOSTIC TESTS FOR WHEAT CHALLENGE REACTION: WHEAT CHALLENGE REACTION: KAMUT
PT TYPE RESULT IMMED DELAYED IMMED DELAYED ALLOWED
1 IgG4 1.2 + - + - No
2 IgG4 5.9 + - - - Yes
3 IgG 3.0 + + - - Yes
4 IgG4 2.7 + + - - Yes
5 Sympt +++ + + + - No
6 ST 2+ + - + + No
7 ST 2+ + + - - Yes
8 Sympt ++ - + - - Yes
9 IgG 6+ + + - - Yes
10 IgG4 1.1 - + - - Yes


DIAGNOSTIC TEST RANGE:

IgG4: 1-6+
IgG: 0 (low), + (moderate), 0/+ (high)
ST: Skin Tests 1-4+
Symptom: These patients were on Hisminal or Prednisone at the time of the initial evaluation, but had a strong history of allergic reactions to wheat. During the challenges they were off these medications.

Two of the patients had no reaction. Five patients had very minor symptoms such as a runny or itchy nose, a mild headache (1+ out of a possible score of 10+ with 10+ being a migraine) lasting less than a half hour and an earache (1+). Three of the ten patients had serious reactions to the Kamut. The reactions consisted of a decreased Pulmonary Function Test of 20 %, pains in the joints, an asthma attack and anaphalatic shock. Two of these three patients were sick for more than a week and needed to take Prednisone and other medications to control their symptoms.

Table 5. Comparative Analysis Between Wheat and Kamut Food Challenges with 10 patients.

A histogram displaying the proportion of reactions between wheat and Kamut food challenges. As can be seen by the histogram, every patient had a greater reaction to wheat than to Kamut. Eight patients developed abdominal cramps, spasms, and pain to wheat, whereas only two had these symptoms to Kamut. Seven patients complained of both fatigue and headaches to wheat, whereas only two developed these symptoms to Kamut. The most important difference between the wheat and Kamut challenge is that half (five) of the patients developed asthma, tightness in the chest and/or wheezing to wheat. However, no one developed these asthmatic symptoms to Kamut. Another interesting observation is that three patients developed itching and hives to Kamut and only one patient developed these symptoms after challenging Kamut.

SYMPTOMS

1. Abdominal cramps/pain/spasms 8. Hyperactivity/jittery
2. Fatigue 2+ - 10+ 9. Chills/perspiration
3. Headaches 5+ - 10+ /migraines 10. Numbness in hands, lips, throat
4. Joint pain spasms 11. Diarrhea
5. Asthma/wheezing/tightness in chest 12. Dizziness
6. Runny nose/post nasal drip 13. Itching/hives
7. Nausea/indigestion 14. Coughing/difficulty in swallowing

CONCLUSION

It appears that a majority of patients with IgG Delayed reactions to common wheat can tolerate Kamut better than patients who have IgE immediate reactions to wheat. Since most patients have delayed IgG reactions to all foods, it appears that Kamut can be an excellent substitution for common wheat if eaten on a rotational basis. However, everyone with a serious food allergy to wheat should be evaluated carefully by their physician before trying any new grains.

REFERENCES

1) Atkins, F.M., Steinburg, S.S. and D.D. Metcalfe.: I. Evaluation of immediate adverse reactions to foods in adult patients. II. A detailed analysis of reaction patterns during oral food challenge. J. Allergy Clin. Immunol.. 75:356, 1985.

2) Klein, G.G., Miller, M. And R.W. Ziering.: A Simplified Food Challenge for Allergic Rhinitis and Atopic Dermatitis. Immunology & Allergy Practice 39:373, 1985

3) Leinhas, J.L., McCaskill, C.C., and H.A. Sampson.:Food Allergy Challenges: Guidelines and Implications. Research 87:604, 1987.

4) Pelikan, S. And M. Pelikan-Filipek.: Bronchial response to the Food Ingestion Challenge. Annals of Allergy 58:164, 1987.

5) Sampson, H. and R. Albergo.: Comparison of Results of Skin Tests, RAST, and Double-Blind, Placebo-Controlled Food Challenges in Children with Atopic Dermatitis. J. Allergy Clin. Immunol.. 74:28, 19984.

6)Yoder, E.: Maintaining Patent Compliance During the Elimination Diet. Handbook of Food Allergy. Marcell-Dekker Chapter 13, 1987.


* Kamut is a registered trademark of Kamut International, Ltd.

 

QUALITY FACTS


CERTIFIED ORGANIC WHOLE GRAINS - grown without synthetic chemicals.
STONE GROUND FLOURS - cold-milled, to preserve nutrients.
ROLL-AND-CUT - prepared following a Japanese process that allows more fiber content.
AIR-DRIED - to protect the freshly made flavor and texture.
FRESHLY MADE - to order, so it always tastes fresh.

*Made from grain organically grown and OCIA Third Party Certified Organic.

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