2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets
By Suzanne Barker, MS, RDN, LDN, CGP, clinical coordinator for clinical trials, Vibrant Wellness
Designing clinical trials centered around food and diets can be difficult. Yet, with nearly 20% of U.S. adults believing they have food allergies, the need for these studies requires that we persevere. The scientific community’s understanding of food reactivity has become more nuanced, and studies now suggest food sensitivities may be distinct from food allergies both in symptoms and the underlying immune response. Regardless of category, it’s crucial that patients who suspect their diets may be negatively impacting their health receive confirmatory testing and diagnosis.
With this goal in mind, Vibrant Wellness recently conducted one of the first clinical trials examining food sensitivity, with results currently in pre-print. The study used innovative peptide microarrays to design personalized elimination diets for each of the 52 participants. Multiple endpoints, including biomarkers and quality of life surveys, were then captured at four weeks to assess the effectiveness of the approach. In this article, we discuss the challenges faced and insights gleaned during the design and execution of the study, in the hopes of facilitating more clinical trials in this important and emerging field.
Targeted Intervention, Grounded In Data
Food sensitivities, independent of allergies, are estimated to affect at least 20% of the global population. Driven by IgA and IgG antibody responses, food sensitivities cause abdominal pain, bloating, brain fog, joint pain, and other symptoms of chronic inflammation that negatively impact quality of life. Diagnosing food sensitivities is challenging, as these symptoms overlap with a number of other gastrointestinal diseases. Even with appropriate diagnosis, the gradual development of these symptoms due to repeated exposure to the offending food makes it difficult for patients and clinicians to pinpoint the dietary cause.
The current standard of treatment is an elimination diet. The protocol is strict and difficult to adhere to, and the process can take months or even years to complete, as foods are systematically reintroduced in a guess-and-check manner. To address these issues, Vibrant Wellness developed a proprietary peptide microarray that can detect IgA and IgG antibodies to 262 peptide and whole protein antigens. This allows clinicians to not only detect food sensitivities but also accurately inform patients of which dietary components they are sensitive to.
The food sensitivity clinical trial was designed to determine whether tailored elimination diets (informed by the results of the peptide microarray) were an effective intervention for food sensitivity symptoms. We relied on three different readouts for assessing the outcomes of this study: a patient completed questionnaire known as the Food Sensitivity-Symptom Severity Scale (FS-SSS), a clinician-assigned score on the Food Sensitivity-Global Improvement Scale (FS-GIS), and IgA and IgG antibody titers measured by the Vibrant Wellness peptide microarray.
These readouts are consistent with measurements used in other clinical trials on food sensitivity and food allergy. By including both patient and clinician assessment of symptoms, we hoped to accurately capture any changes in the patient’s quality of life. Antibody titers were included as a quantifiable measurement of the intervention’s efficacy. Together, we felt this would give us reliably robust insights for this exploratory clinical trial.
Building A Strong Network
One of the most important components of clinical research is recruiting physicians, clinics, and healthcare professionals willing to support your study and help gather data. To do this, it’s crucial to clearly communicate the benefits of your research to clinicians and their patients, who were recruited via healthcare practices. For this study, we secured partnerships with providers because we offered access to a technology that addressed an underserved need. Providers were excited to use our peptide microarray to help patients identify the source of their symptoms, which some participants had been dealing with for years.
By clearly demonstrating this benefit, our study secured collaboration with eight different practices across the U.S. Chosen practices provided a representative cross-section of country demographics and had a dedicated contact point for trial coordination and managing logistics, which included education about the study forms, when to fill them out, and explanation on why the patients need to fill out these forms, etc. This sole point of contact allowed us to have constant two-way conversations throughout the study. It’s hard to overstate the value of clear and open communication with providers and their practices. Whether it’s recruiting patients, collecting data, or ensuring providers are equipped with the appropriate supplies, clinical trials live and die on the strength of the communication between research teams.
Two Major Challenges Of Food Sensitivity Studies
We faced several challenges during trial design. The first was participant adherence to clinical trial interventions, which must always factor heavily into trial design. This was particularly important for our diet-based intervention, as we knew that a longer study would increase the likelihood of deviations and potential re-exposure to inflammatory dietary components. However, we also knew our trial must allow enough time for interventions to demonstrate results, in both symptoms and antibody titer. For example, IgG has a half-life between 15 and 30 days, depending on the subtype. After discussion, we landed on a four-week trial to effectively balance these competing needs.
The second challenge was whether to use a control group. One of the enrollment criteria was that patients were presenting with GI symptoms and distress. Participants in this study were tested for food sensitivity using our proprietary peptide microarray. For those that had reactive antibodies to dietary components, we felt it would have been unethical to ask them to continue consuming those foods. While broad, non-specific elimination diets were also considered, we felt patient participation and retention would have suffered due to the difficulty of adhering to such a strict diet. For these reasons, we chose not to include a control group, which added to the complexity of interpreting our data but was the correct decision for patient well-being.
Since our study was observational and lacked a control group due to ethical concerns, we implemented baseline comparison analysis to ensure the robustness and accuracy of our data and conclusions. Participants’ antibody levels and symptoms were compared before and after the elimination diet, allowing us to evaluate changes within each individual and effectively use each participant as their own control. We transparently acknowledged the absence of a control group in our study and contextualized our findings within this limitation in the discussion section of our report. While these measures do not substitute for a traditional control group, they provide a scientifically rigorous interpretation of the observational data we collected. We believe these methods ensure that our conclusions about the effectiveness of the elimination diet are as robust as possible under the circumstances.
Conclusion
As we continue to explore the emerging field of food sensitivity, our hope is that the success of this study prompts future studies with longer observation periods, supplemental data on gut microbiota, and larger cohorts. It’s important to recognize that trade-offs will always be necessary in clinical trials, and the safety, health, and satisfaction of those involved should be prioritized.
About The Author:
Suzanne Barker, clinical coordinator for clinical trials with Vibrant Wellness, is an advocate for health and wholeness, with a dedicated focus on helping individuals achieve optimal well-being. With a master’s in nutrition and a bachelor's in animal science from Texas A&M University, Suzanne brings over 20 years of experience in functional nutrition, coupled with 14 years in lab education and research. Driven by a desire to provide comprehensive care, Suzanne earned a Ph.D. in counseling, blending expertise in nutrition and mental health to offer holistic support.