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Criteria both raw and baked foods?

Comments should be validated.

4. Does the method measure proteins from all relevant foods?

The cereal grains associated with celiac disease include wheat, barley, rye, and their cross-bred hybrids. Oats may be of concern for some celiac patients.

5. Does the method measure both gliadins and glutenins?

The storage proteins in cereal grains (generally referred to as gluten) include both prolamin proteins (gliadins) and glutelin proteins (glutenins). Ideally, both of these should be measured.

6. Is the method practical?

The method should use common laboratory equipment and be reasonably priced.

e. Oral Challenge Studies. The criteria used to evaluate the available gluten oral challenge studies are provided in Table IV-9 and applied in Appendix 5. Only a limited number of gluten or gliadin challenge studies have been conducted. Of these, many have monitored the subjects’ acute responses to a single high dose of gluten or gliadin. These acute studies were not designed to establish a NOAEL or (in most cases) a LOAEL, and the results may not be directly applicable to the chronic, low-level exposures that may lead to long-term consequences. Moreover, most clinical studies only test one or two dose levels and do not directly measure daily intestinal responses to gluten. Based on the criteria in Table IV-9, two currently available studies are considered to be of high utility. The data in these studies can be used to calculate LOAELs for short-term exposures. Although one study retrospectively assessed the effects of trace amounts of gluten consumption in diets of individuals for up to 10 years (Collin et. al., 2004), there are no prospective data on the impact of chronic or long-term consumption of lower gluten levels.

Table IV-9. Specific Criteria for Evaluating Gluten Oral Challenge Studies

Criteria

Comments

1. Has the study been published in a peer-

Published, peer-reviewed studies are

reviewed journal?

preferred although unpublished studies may be considered.

2. Were the criteria for selecting the test population clearly and completely described?

This information is needed to evaluate how the study results apply to the at-risk population.

3. Was the tested food material clearly and completely described?

It is important to know the level of gluten in the test material.

4. Was the dose regime clearly and

A study designed to measure chronic

Revised Threshold Report Page 60 of 108

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