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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elimination Diet | Experimental | Participants will be suggested an 'Elimination diet' that will be devoid of the reaction-inducing foods and it shall be followed for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elimination Diet | Behavioral | An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in blood biomarker profile | 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. | Baseline - 4 weeks |
| Improvement in severity of food sensitivity symptoms | 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). | Baseline; Week 1; Week 2; Week 3; Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Food Sensitivity - Quality of Life Questionnaire (FS-QoL) | 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. | Baseline; Week 4 |
| Food sensitivity - Global Improvement Scale (FS-GIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hari K Krishnamurthy, M.S. | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Natural Health | Gilbert | Arizona | 85298 | United States | ||
| Inside Out Aesthetics |
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| ID | Term |
|---|---|
| D000073923 | Food Intolerance |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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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. |
| Week 4 |
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Vitality MD's | Scottsdale | Arizona | 85258 | United States |
| Mr. Hari Krishnamurthy | San Carlos | California | 94070 | United States |
| Vitality Health and Wellness | Miami Beach | Florida | 33139 | United States |
| Institute for Hormonal Balance | Orlando | Florida | 32819 | United States |
| One Agora Integrative Health | Bloomington | Minnesota | 55431 | United States |
| Turnpaugh Health and Wellness Center - Manheim | Manheim | Pennsylvania | 17545 | United States |
| Turnpaugh Health and Wellness Center - Mechanicsburg | Mechanicsburg | Pennsylvania | 17050 | United States |