IgG-mediated Food Test for Weight Loss

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592071
• Other study ID #: 20080670
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: February 14, 2014
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami CRB	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Immuno Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (kg)	Measure of body composition: weight (kg).	30, 60 and 90 days from baseline	No
Primary	Body Mass Index	Measure of body composition: height and weight to assess BMI.	30, 60 and 90 days from baseline	No
Primary	Waist Circumference	Measure of body composition: waist circumference (cm).	30, 60 and 90 days from baseline	No
Primary	Hip Circumference	Measure of body composition: hip circumference (cm).	30, 60 or 90 days from baseline	No
Primary	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	No
Secondary	Blood Pressure	Systolic and diastolic blood pressure measured.	30, 60 and 90 days from baseline	No
Secondary	Heart Rate	Heart rate measured.	30, 60 and 90 days from baseline	No
Secondary	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	No