IgG-mediated Food Test for Weight Loss

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Replace reactive foods with non-reactive foods

• Registration Number: NCT01592071
• Lead Sponsor: University of Miami

Brief Summary

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

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-07
• Results First Submitted: 2012-08-23
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Results First Posted: 2014-03-31
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Replace reactive w/ non-reactive foods	Replace reactive foods with non-reactive foods	Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods'

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	30, 60 and 90 days from baseline	Systolic and diastolic blood pressure measured.
Heart Rate	30, 60 and 90 days from baseline	Heart rate measured.
Quality of Life	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.

Trial Locations

Locations (1)

University of Miami CRB; 🇺🇸 Miami, Florida, United States