Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

Vibrant

Status: Completed

Conditions: Food Sensitivity

Treatments: Behavioral: Elimination Diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05389683

IRB # 1-1586736-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Elimination Diet

Experimental group

Description:

Participants will be suggested an 'Elimination diet' that will be devoid of the reaction-inducing foods and it shall be followed for 4 weeks.

Treatment:

Behavioral: Elimination Diet