NCT05389683

Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vibrant America Clinical Lab · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Food Sensitivity

Interventions

Type	Name	Description
BEHAVIORAL	Elimination Diet	An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.

Timeline

• Start date: 2023-01-02
• Primary completion: 2024-02-24
• Completion: 2024-02-24
• First posted: 2022-05-25
• Last updated: 2024-06-18

Locations

9 sites across 1 country: United States