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NCT Number: NCT05389683

Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

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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Key information

Conditions

Food Sensitivity Food Intolerance Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hope Natural Health, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elimination Diet

Behavioral

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

Primary outcomes

  1. Improvement in blood biomarker profile

    Time frame: 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.

  2. Improvement in severity of food sensitivity symptoms

    Time frame: 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).

Secondary outcomes

  1. Food Sensitivity - Quality of Life Questionnaire (FS-QoL)

    Time frame: 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.

  2. Food sensitivity - Global Improvement Scale (FS-GIS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vibrant America Clinical Lab

Industry

Registry information

Official study title

Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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