Clinical trial NCT05389683: Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms
Official title: Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Sensitivity
Keywords: Food Sensitivity
Elimination diet
Lead sponsor: Vibrant America Clinical Lab
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in blood biomarker profile
timeFrame: Baseline - 4 weeks
measure: Improvement in severity of food sensitivity symptoms
timeFrame: Baseline; Week 1; Week 2; Week 3; Week 4
Secondary outcomes:
measure: Food Sensitivity - Quality of Life Questionnaire (FS-QoL)
timeFrame: Baseline; Week 4
measure: Food sensitivity - Global Improvement Scale (FS-GIS)
timeFrame: Week 4
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Hope Natural Health
state: Arizona
city: Scottsdale
country: United States
facility: Inside Out Aesthetics
state: Arizona
city: Scottsdale
country: United States
facility: Vitality MD's
state: Arizona
city: San Carlos
country: United States
facility: Mr. Hari Krishnamurthy
state: California
city: Miami Beach
country: United States
facility: Vitality Health and Wellness
state: Florida
city: Orlando
country: United States
facility: Institute for Hormonal Balance
state: Florida
city: Bloomington
country: United States
facility: One Agora Integrative Health
state: Minnesota
city: Manheim
country: United States
facility: Turnpaugh Health and Wellness Center - Manheim
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Turnpaugh Health and Wellness Center - Mechanicsburg
state: Pennsylvania
Study officials:
affiliation: PI
name: Hari K Krishnamurthy, M.S.
role: PRINCIPAL_INVESTIGATOR
References: