Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2024-02-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Food Sensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Elimination Diet

Intervention Type BEHAVIORAL

An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.

Interventions

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Elimination Diet

An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No