Food Sensitivity
Conditions
Keywords
Food Sensitivity, Elimination diet
Brief summary
The goal is to identify food sensitivity in patients and assess whether the avoidance of the reaction-inducing foods via an 'elimination diet' leads to improvement in patient symptoms and overall well-being.
Detailed description
After seeking appropriate consent, patients' blood samples will be tested for the reactivity toward 262 foods using peptide and protein microarrays. Food protein extraction will be carried out in different solvents such as water and alcohol. The peptide microarrays will synthesize the entire food proteins as peptides in situ while the protein microarrays will test for water-soluble and alcohol-soluble fractions. Thus, food sensitivity testing will be carried out at 3 different levels including water-soluble proteins, alcohol-soluble proteins, and peptides. Patients' blood samples can be tested at all 3 levels or a combination of these. This decision lies at the discretion of the physician. Based on the test results and as per the physician's recommendations, a suitable elimination diet will be suggested to the patient. Personalized diet suggestions for each patient will be made by the physician. The patient will follow the diet for 4 weeks and blood samples will be tested again on completion of the diet, using peptides and protein microarrays. Additionally, based on the physician's recommendations, the time duration for which a patient follows the personalized elimination diet can be modified. The patients will periodically have to fill out diagnostic questionnaires which will help assess the changes in their food sensitivity-related symptoms. Changes in the blood biomarkers and improvement in symptoms will be monitored during the study.
Interventions
BEHAVIORALElimination Diet
An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.
Sponsors
Vibrant America Clinical Lab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
It is a single group study in which a single group of subjects will receive a single intervention and the outcomes will be assessed over time.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 to 65 years. * Patients suffering from food sensitivity symptoms * Patients having Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-mediated food reactions leading to food sensitivity * Patients agreeing to follow the diet per testing * Patients willing to provide an informed consent
Exclusion criteria
* Patients suffering from chronic medical conditions like cancer * Pregnant subjects * Patients who have recently used antibiotics * Patients who have previously undergone treatments for food allergies/sensitivities * Patients who have been assigned an elimination diet before * Patients who are already following a restricted diet of any kind * Patients unwilling/unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in blood biomarker profile | Baseline - 4 weeks | The peptide and protein microarrays will be used to test patients' blood samples prior to and post-employment of the elimination diet, and changes in the blood biomarker profile will be monitored. Testing will be carried out at baseline and then after 4 weeks, on completion of the diet. |
| Improvement in severity of food sensitivity symptoms | Baseline; Week 1; Week 2; Week 3; Week 4 | Food Sensitivity - Symptom Severity Scale (FS - SSS) is a 16-item questionnaire that will assess the severity of the patient's food sensitivity-related symptoms. The scores range from 0 (none) to 5 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Sensitivity - Quality of Life Questionnaire (FS-QoL) | Baseline; Week 4 | The FS-QoL is a 21-item measure assessing the degree to which Food Sensitivity-related symptoms interfere with a patient's quality of life. Each item is rated on a 5-point Likert scale. |
| Food sensitivity - Global Improvement Scale (FS-GIS) | Week 4 | The FS-GIS is a single-item assessment of overall Food Sensitivity symptoms and improvement. This questionnaire will be filled out by the physician to report the patient's response to the given intervention. It poses the question to the physician Compared to the patient's condition during admission to the project \[prior to intervention initiation\], has the patient's food sensitivity-related symptoms been: The physician can select: 1 = Substantially Improved, 2 = Moderately Improved, 3 = Slightly Improved, 4 = No change, 5 = Slightly Worse, 6 = Moderately Worse, 7 = Substantially Worse. |
Countries
United States
Outcome results
None listed