IgG-mediated Food Test for Weight Loss

Study Overview
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Brief Summary
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This study assessed the effect of an IgG-mediated food sensitivity test in combination with a food elimination diet on body composition and secondary outcomes in people who were overweight.

Detailed Description
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This study looked at foods that stimulated IgG food antibody production, which may play a role in certain conditions, such as irritable bowel syndrome, obesity, type I diabetes, and migraine headaches. Using a proprietary blood test, the Immuno Bloodprint, to determine which foods stimulate IgG food antibodies in each person, this study detailed a personalized list of reactive foods that stimulated such antibodies for each participant. The participant was then advised to eliminate as much as possible the reactive foods for 90 days.

Official Title
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Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Replace reactive foods with non-reactive foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI above 20 Express an interest in losing weight Exclusion Criteria: Less than 18 years of age Currently participating in another research trial for weight loss Suffering from serious medical complications that might limit their participation, such as recent heart attack, stroke, or chronic kidney disease Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replace reactive w/ non-reactive foods<br>Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods' | Other: Replace reactive foods with non-reactive foods<br>* Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements per the Immuno Bloodprint results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) | Measure of body composition: weight (kg). | 30, 60 and 90 days from baseline | 
| Body Mass Index | Measure of body composition: height and weight to assess BMI. | 30, 60 and 90 days from baseline | 
| Waist Circumference | Measure of body composition: waist circumference (cm). | 30, 60 and 90 days from baseline | 
| Hip Circumference | Measure of body composition: hip circumference (cm). | 30, 60 or 90 days from baseline | 
| Waist-Hip Ratio (WHR) | Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR). | 30, 60 or 90 days from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Systolic and diastolic blood pressure measured. | 30, 60 and 90 days from baseline | 
| Heart Rate | Heart rate measured. | 30, 60 and 90 days from baseline | 
| Quality of Life | Quality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life. | 30, 60 or 90 days from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food sensitivity, IgG, obesity, overweight, body composition, reactive foods