We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05389683
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : January 4, 2023
Information provided by (Responsible Party):
Hari Krishnamurthy, Vibrant America Clinical Lab

Brief 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.

Condition or disease Intervention/treatment Phase
Food Sensitivity Behavioral: Elimination Diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet
Actual Study Start Date : January 2, 2023
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.

Primary Outcome Measures :
  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 15-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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389683

Layout table for location contacts
Contact: Hari K Krishnamurthy, M.S. 5094325707 hari@vibrantsci.com

Layout table for location information
United States, Arizona
Hope Natural Health Recruiting
Gilbert, Arizona, United States, 85298
Contact: Erin Ellis    480-630-1665    drellis@hopenaturalhealth.com   
Principal Investigator: Erin Erin, ND         
Causenta Wellness Recruiting
Scottsdale, Arizona, United States, 85250
Contact: Tom Incledon    480-247-8377    thomasincledon@causenta.com   
Principal Investigator: Tom Incledon, PhD         
Inside Out Aesthetics Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Shasti Cooper    480-307-9901    shasti@insideoutaesthetics.com   
Principal Investigator: Burt Webb, MD         
Vitality MD's Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Janis Rustad    480-425-8700    jrustad@vitalitymds.com   
Principal Investigator: Burt Webb, MD         
United States, California
Mr. Hari Krishnamurthy Recruiting
San Carlos, California, United States, 94070
Contact: Hari K Krishnamurthy, M.S.    509-432-5707    hari@vibrantsci.com   
United States, Florida
Vitality Health and Wellness Recruiting
Miami Beach, Florida, United States, 33139
Contact: Andrew Levinson    305-466-1100    yogimd@vitalitywellness.com   
Principal Investigator: Andrew Levinson, MD, APRN         
Institute for Hormonal Balance Recruiting
Orlando, Florida, United States, 32819
Contact: Rebecca Murray    860-608-5352    rebeccamurrayaprn@gmail.com   
Principal Investigator: Edwin Lee, MD         
Principal Investigator: Rebecca Murray, APRN         
Athletic Sports Medicine and Wellness Recruiting
Orlando, Florida, United States, 32832
Contact: Cyd C Williams    407-413-4984    infinitehealth@drcydcharisse.com   
Principal Investigator: Cyd C Williams, MD, APRN         
United States, Minnesota
One Agora Integrative Health Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Shannon Rosenbaum    952-234-5898    info@oneagorahealth.com   
Principal Investigator: Meaghan Kirschling, DC         
United States, Pennsylvania
Turnpaugh Health and Wellness Center - Manheim Recruiting
Manheim, Pennsylvania, United States, 17545
Contact: Brianna Bloomer    717-879-9899    brianna@turnpaughhwc.com   
Principal Investigator: Chris Turnpaugh, DC         
Principal Investigator: Cynthia West, MD         
Turnpaugh Health and Wellness Center - Mechanicsburg Recruiting
Mechanicsburg, Pennsylvania, United States, 17050
Contact: Brianna Bloomer    717-879-9899    brianna@turnpaughhwc.com   
Principal Investigator: Chris Turnpaugh, DC         
Principal Investigator: Cynthia West, MD         
Sponsors and Collaborators
Vibrant America Clinical Lab
Layout table for investigator information
Principal Investigator: Hari K Krishnamurthy, M.S. PI
Layout table for additonal information
Responsible Party: Hari Krishnamurthy, Director - Biomedical Engineering, Vibrant America Clinical Lab
ClinicalTrials.gov Identifier: NCT05389683    
Other Study ID Numbers: 20213576
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hari Krishnamurthy, Vibrant America Clinical Lab:
Food Sensitivity
Elimination diet
Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases