Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

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

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.

Study Overview

• Status: Completed
• Conditions: Food Sensitivity
• Intervention / Treatment: Behavioral: Elimination Diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85298
      • Hope Natural Health
    • Scottsdale, Arizona, United States, 85254
      • Inside Out Aesthetics
    • Scottsdale, Arizona, United States, 85258
      • Vitality MD's
  • California
    • San Carlos, California, United States, 94070
      • Mr. Hari Krishnamurthy
  • Florida
    • Miami Beach, Florida, United States, 33139
      • Vitality Health and Wellness
    • Orlando, Florida, United States, 32819
      • Institute for Hormonal Balance
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • One Agora Integrative Health
  • Pennsylvania
    • Manheim, Pennsylvania, United States, 17545
      • Turnpaugh Health and Wellness Center - Manheim
    • Mechanicsburg, Pennsylvania, United States, 17050
      • Turnpaugh Health and Wellness Center - Mechanicsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Elimination Diet; An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Vibrant America Clinical Lab
• Investigators: Principal Investigator: Hari K Krishnamurthy, M.S., PI

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): February 24, 2024
• Study Completion (Actual): February 24, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Food Sensitivity; Elimination diet
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: IRB # 1-1586736-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No