Advanced Technology in Food Production

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ATFP: Human Consumption of Plant Foods Produced Using Genetic Engineering (GE) Technologies (2015)

Citation:
Yum HY, Lee SY, Lee KE, Sohn MH, Kim KE. Genetically modified and wild soybeans: an immunologic comparison. Allergy Asthma Proc. 2005; 26 (3): 210-216. PubMed ID: 16119037
 
Study Design:
Non-Randomized Crossover Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
The purpose of this study was to assess the allergenicity of GMOs, we compared genetically modified organisms (GMOs) soybeans and wild soybeans in terms of their immunologic and physicochemical characteristics and quantified immunoglobulin E (IgE) and performed immunoblotting in sensitive patients.
Inclusion Criteria:
Pediatric patients visiting the allergy clinic.
Exclusion Criteria:
None specifically mentioned.
Description of Study Protocol:
  • Recruitment: Pediatric patients at the allergy clinics of Severance Hospital, Yonsei University and Ajou University
  • Design: Nonrandomized crossover trial
  • Blinding used: Implied with measurements.

Intervention

  • Skin-prick testing was performed using 60 different antigens, including soybeans
  • IgE immunoblotting
  • Crude extracts of GMO and wild soybeans prepared.

Statistical Analysis
Not described.

Data Collection Summary:

Timing of Measurements

Step-wise testing process

  • Measure One: Crude Antigen Prep/SDS-PAGE (sodium dodecyl sulfate-polyacrylamide gel electrophoresis)
  • Measure Two: Heat and Chemical Treatment
  • Measure Three: Polymerase Chain Reaction
  • Measure Four: Skin testing
  • Measure Five: Capsulated Allergen Product Test
  • Measure Six: IgE Immunoblotting.

Dependent Variables

  • SDS-PAGE Observations
  • PCR Expression
  • Skin prick allergenicity response
  • IgE Binding.

Independent Variables

GMO vs. wild soybean antigen.
Description of Actual Data Sample:
  • Initial N: 49 children
  • Attrition (final N): 49 children
  • Age: Not mentioned
  • Ethnicity: Korean.

Other Relevant Demographics
Sera pools

  • Lane One: N=5; under two years of age; with atopic dermatitis or food allergy
  • Lane Two: N=4; over two years of age; with respiratory allergy.

Location
Korea.

Summary of Results:

Key Findings

  • Crude antigen preparation: GMO soybeans revealed a distinct protein band at 80kDa and wild soybeans revealed a distinct protein band at 50kDa. Below 40kDa, the two samples showed similar protein band distributions.
  • Heat and chemical treatment
    • No differences were observed between GMO and wild soybean, when treated with heat
    • No differences were observed with chemical treatment between GMO and wild soybean, when compared to a whey protein control.
  • PCR GMO confirmation: Findings showed a 195-bp fragment and 570-bp fragment, which are consistent to the GMO soybean gene EPSP. This was confirmed with commercial products containing the gene as well.
  • Skin testing and IgE immunoblotting
    • Out of 49 children, 13 reacted to wild soybean and eight reacted to GMO soybean. Only one child showed a positive reaction to GMO only.
    • Sera from nine patients with positive skin tests to the crude extract and a positive capsulated allergen product test to the soybean antigen were used for the immunoblotting of GMO and wild soybeans
    • GMO soybeans revealed a unique strong immunoglobulin E-binding band at 25kDa in some patients and wild soybeans showed a strong immunoglobulin E-binding band at 30kDa to 36kDa.
Author Conclusion:
To assess the allergenicity of GMOs, further research is needed using a more extensive collection of patients with a convincing clinical history and using materials prepared in a controlled environment.
Funding Source:
Government: Ministry of Health and Welfare of the Republic of Korea
University/Hospital: Pochon CHA University, Ajou University, Yonsei University.
Reviewer Comments:
  • The author indicates that the major shortcoming is that the guidelines recommended by the Food and Agriculture Organization/World Health Organization indicate that there needs to be more than25 serum samples showing high IgE
  • There was also a limitation with collecting sera from children who did not have any severe clinical symptoms to soybeans.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? No
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? No
  2.2. Were criteria applied equally to all study groups? N/A
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? ???
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  8.3. Were statistics reported with levels of significance and/or confidence intervals? No
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? No
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? No