Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

NCT05389683 | Completed

• 1 other identifier: IRB # 1-1586736-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

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.

Conditions

Food Sensitivity

Keywords

Food Sensitivity; Elimination diet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Food Sensitivity - Quality of Life Questionnaire (FS-QoL)

  Baseline; Week 4

• Food sensitivity - Global Improvement Scale (FS-GIS)

  Week 4

Study Arms (1)

Elimination Diet

EXPERIMENTAL

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

Interventions

Elimination Diet BEHAVIORAL

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

Elimination Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vibrant America Clinical Lab: lead

Study Sites (9)

Hope Natural Health

Gilbert, Arizona, 85298, United States

Location

Inside Out Aesthetics

Scottsdale, Arizona, 85254, United States

Location

Vitality MD's

Scottsdale, Arizona, 85258, United States

Location

Mr. Hari Krishnamurthy

San Carlos, California, 94070, United States

Location

Vitality Health and Wellness

Miami Beach, Florida, 33139, United States

Location

Institute for Hormonal Balance

Orlando, Florida, 32819, United States

Location

One Agora Integrative Health

Bloomington, Minnesota, 55431, United States

Location

Turnpaugh Health and Wellness Center - Manheim

Manheim, Pennsylvania, 17545, United States

Location

Turnpaugh Health and Wellness Center - Mechanicsburg

Mechanicsburg, Pennsylvania, 17050, United States

Location

MeSH Terms

Conditions

Food Intolerance

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hari K Krishnamurthy, M.S.

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Biomedical Engineering

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: January 2, 2023
• Primary Completion: February 24, 2024
• Study Completion: February 24, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)