IgG-mediated Food Test for Weight Loss
|ClinicalTrials.gov Identifier: NCT01592071|
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : March 31, 2014
Last Update Posted : March 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Other: Replace reactive foods with non-reactive foods||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592071
|United States, Florida|
|University of Miami CRB|
|Miami, Florida, United States, 33136|
|Principal Investigator:||John E Lewis, PhD||University of Miami|