IgG-mediated Food Test for Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Replace reactive foods with non-reactive foods

Detailed Description

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami CRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Immuno Laboratories
• Investigators: Principal Investigator: John E Lewis, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: obesity; overweight; body composition; food sensitivity; IgG; reactive foods
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 20080670

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No