IgG-mediated Food Test for Weight Loss
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons|
- Weight (kg) [ Time Frame: 30, 60 and 90 days from baseline ]Measure of body composition: weight (kg).
- Body Mass Index [ Time Frame: 30, 60 and 90 days from baseline ]Measure of body composition: height and weight to assess BMI.
- Waist Circumference [ Time Frame: 30, 60 and 90 days from baseline ]Measure of body composition: waist circumference (cm).
- Hip Circumference [ Time Frame: 30, 60 or 90 days from baseline ]Measure of body composition: hip circumference (cm).
- Waist-Hip Ratio (WHR) [ Time Frame: 30, 60 or 90 days from baseline ]Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).
- Blood Pressure [ Time Frame: 30, 60 and 90 days from baseline ]Systolic and diastolic blood pressure measured.
- Heart Rate [ Time Frame: 30, 60 and 90 days from baseline ]Heart rate measured.
- Quality of Life [ Time Frame: 30, 60 or 90 days from baseline ]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.
|Study Start Date:||October 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Replace reactive w/ non-reactive foods
Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods'
Other: Replace reactive foods with non-reactive foods
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592071
|United States, Florida|
|University of Miami CRB|
|Miami, Florida, United States, 33136|
|Principal Investigator:||John E Lewis, PhD||University of Miami|