Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

Food Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389683
• Other study ID #: IRB # 1-1586736-1
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: February 24, 2024

Study information

• Verified date: June 2024
• Source: Vibrant America Clinical Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 24, 2024
• Est. primary completion date: February 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Sensitivity
• Hypersensitivity

Intervention

Behavioral:
• Elimination Diet
An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.

Locations

Country	Name	City	State
United States	One Agora Integrative Health	Bloomington	Minnesota
United States	Hope Natural Health	Gilbert	Arizona
United States	Turnpaugh Health and Wellness Center - Manheim	Manheim	Pennsylvania
United States	Turnpaugh Health and Wellness Center - Mechanicsburg	Mechanicsburg	Pennsylvania
United States	Vitality Health and Wellness	Miami Beach	Florida
United States	Institute for Hormonal Balance	Orlando	Florida
United States	Mr. Hari Krishnamurthy	San Carlos	California
United States	Inside Out Aesthetics	Scottsdale	Arizona
United States	Vitality MD's	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vibrant America Clinical Lab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in blood biomarker profile	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.	Baseline - 4 weeks
Primary	Improvement in severity of food sensitivity symptoms	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).	Baseline; Week 1; Week 2; Week 3; Week 4
Secondary	Food Sensitivity - Quality of Life Questionnaire (FS-QoL)	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.	Baseline; Week 4
Secondary	Food sensitivity - Global Improvement Scale (FS-GIS)	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.	Week 4