Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms
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| ClinicalTrials.gov Identifier: NCT05389683 |
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Recruitment Status :
Recruiting
First Posted : May 25, 2022
Last Update Posted : January 4, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Food Sensitivity | Behavioral: Elimination Diet | Not Applicable |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Elimination Diet
An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks. |
- 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.
- 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).
- 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.
- 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.
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.
| 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
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
| Contact: Hari K Krishnamurthy, M.S. | 5094325707 | hari@vibrantsci.com |
| United States, Arizona | |
| Hope Natural Health | Recruiting |
| Gilbert, Arizona, United States, 85298 | |
| Contact: Erin Ellis 480-630-1665 drellis@hopenaturalhealth.com | |
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| 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 | |
| Principal Investigator: | Hari K Krishnamurthy, M.S. | PI |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Food Sensitivity Elimination diet |
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Hypersensitivity Immune System Diseases |