Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

Last updated: June 17, 2024
Sponsor: Vibrant America Clinical Lab
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Allergy

Treatment

Elimination Diet

Clinical Study ID

NCT05389683
IRB # 1-1586736-1
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 foodreactions leading to food sensitivity

  • Patients agreeing to follow the diet per testing

  • Patients willing to provide an informed consent

Exclusion

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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Elimination Diet
Phase:
Study Start date:
January 02, 2023
Estimated Completion Date:
February 24, 2024

Study 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.

Connect with a study center

  • Hope Natural Health

    Gilbert, Arizona 85298
    United States

    Site Not Available

  • Causenta Wellness

    Scottsdale, Arizona 85250
    United States

    Active - Recruiting

  • Inside Out Aesthetics

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Vitality MD's

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Mr. Hari Krishnamurthy

    San Carlos, California 94070
    United States

    Site Not Available

  • Vitality Health and Wellness

    Miami Beach, Florida 33139
    United States

    Site Not Available

  • Athletic Sports Medicine and Wellness

    Orlando, Florida 32832
    United States

    Active - Recruiting

  • Institute for Hormonal Balance

    Orlando, Florida 32819
    United States

    Site Not Available

  • One Agora Integrative Health

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Turnpaugh Health and Wellness Center - Manheim

    Manheim, Pennsylvania 17545
    United States

    Site Not Available

  • Turnpaugh Health and Wellness Center - Mechanicsburg

    Mechanicsburg, Pennsylvania 17050
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.