Food SensitivityNCT05389683
Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms
A study testing Elimination Diet in people with Food Sensitivity, run by Vibrant America Clinical Lab at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Food Sensitivity
- What is being tested?
- Elimination Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Jan 2023to 24 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
One Agora Integrative Health
Bloomington, Minnesota, 55431
Hope Natural Health
Gilbert, Arizona, 85298
Turnpaugh Health and Wellness Center - Manheim
Manheim, Pennsylvania, 17545
Turnpaugh Health and Wellness Center - Mechanicsburg
Mechanicsburg, Pennsylvania, 17050
Vitality Health and Wellness
Miami Beach, Florida, 33139
Institute for Hormonal Balance
Orlando, Florida, 32819
Mr. Hari Krishnamurthy
San Carlos, California, 94070
Inside Out Aesthetics
Scottsdale, Arizona, 85254
Vitality MD's
Scottsdale, Arizona, 85258
About this study
Official title: Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet
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.
Read the 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
- Being tested
- Elimination Diet
- Keywords
- Food Sensitivity, Elimination diet
- Medical subject headings
- Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elimination DietBehavioural
An 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline; Week 1; Week 2; Week 3; Week 4
Secondary outcomes (2)
Food Sensitivity - Quality of Life Questionnaire (FS-QoL)
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.
Measured: Baseline; Week 4
Food sensitivity - Global Improvement Scale (FS-GIS)
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start2 Jan 2023
- Primary completion24 Feb 2024
- Study completion24 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant America Clinical Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hari Krishnamurthy, Vibrant America Clinical Lab
- Investigators
- Hari K Krishnamurthy, M.S., Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389683
- Sponsor's protocol ID
- IRB # 1-1586736-1
- Status last verified
- Jun 2024
- First submitted
- 19 May 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet
- ClinicalTrials.gov ID
- NCT05389683
- Acronym / sponsor ID
- IRB # 1-1586736-1
- Conditions
- Food Sensitivity
- Keywords
- Food Sensitivity, Elimination diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vibrant America Clinical LabIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 24 Feb 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Elimination Diet | Experimental | Behavioral: Elimination DietParticipants will be suggested an 'Elimination diet' that will be devoid of the reaction-inducing foods and it shall be followed for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elimination DietAn 'elimination diet' devoid of the reaction-inducing foods will be suggested for 4 weeks. | Behavioural | Elimination Diet |
Primary outcome
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 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).
2 secondary outcomes
Food Sensitivity - Quality of Life Questionnaire (FS-QoL)
Time frame: Baseline; Week 4
Food sensitivity - Global Improvement Scale (FS-GIS)
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hari K Krishnamurthy, M.S. principal investigator
PI
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elimination Diet in people with Food Sensitivity, run by Vibrant America Clinical Lab at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in blood biomarker profile (time frame: Baseline - 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.