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 patients 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.
|