Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms
- Conditions
- Food Sensitivity
- Interventions
- Behavioral: Elimination Diet
- Registration Number
- NCT05389683
- Lead Sponsor
- Vibrant America Clinical Lab
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elimination Diet Elimination Diet Participants will be suggested an 'Elimination diet' that will be devoid of the reaction-inducing foods and it shall be followed for 4 weeks.
- Primary Outcome Measures
Name Time Method 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).
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (9)
Hope Natural Health
🇺🇸Gilbert, Arizona, United States
Inside Out Aesthetics
🇺🇸Scottsdale, Arizona, United States
Vitality Health and Wellness
🇺🇸Miami Beach, Florida, United States
Mr. Hari Krishnamurthy
🇺🇸San Carlos, California, United States
Institute for Hormonal Balance
🇺🇸Orlando, Florida, United States
One Agora Integrative Health
🇺🇸Bloomington, Minnesota, United States
Turnpaugh Health and Wellness Center - Manheim
🇺🇸Manheim, Pennsylvania, United States
Turnpaugh Health and Wellness Center - Mechanicsburg
🇺🇸Mechanicsburg, Pennsylvania, United States
Vitality MD's
🇺🇸Scottsdale, Arizona, United States