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IgG-mediated Food Test for Weight Loss

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Replace reactive foods with non-reactive foods
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring food sensitivity, IgG, obesity, overweight, body composition, reactive foods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami CRB

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Replace reactive w/ non-reactive foods

Arm Description

Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods'

Outcomes

Primary Outcome Measures

Weight (kg)
Measure of body composition: weight (kg).
Body Mass Index
Measure of body composition: height and weight to assess BMI.
Waist Circumference
Measure of body composition: waist circumference (cm).
Hip Circumference
Measure of body composition: hip circumference (cm).
Waist-Hip Ratio (WHR)
Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).

Secondary Outcome Measures

Blood Pressure
Systolic and diastolic blood pressure measured.
Heart Rate
Heart rate measured.
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.

Full Information

First Posted
May 1, 2012
Last Updated
February 14, 2014
Sponsor
University of Miami
Collaborators
Immuno Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01592071
Brief Title
IgG-mediated Food Test for Weight Loss
Official Title
Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Immuno Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
food sensitivity, IgG, obesity, overweight, body composition, reactive foods

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Replace reactive w/ non-reactive foods
Arm Type
Experimental
Arm Description
Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods'
Intervention Type
Other
Intervention Name(s)
Replace reactive foods with non-reactive foods
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight (kg)
Description
Measure of body composition: weight (kg).
Time Frame
30, 60 and 90 days from baseline
Title
Body Mass Index
Description
Measure of body composition: height and weight to assess BMI.
Time Frame
30, 60 and 90 days from baseline
Title
Waist Circumference
Description
Measure of body composition: waist circumference (cm).
Time Frame
30, 60 and 90 days from baseline
Title
Hip Circumference
Description
Measure of body composition: hip circumference (cm).
Time Frame
30, 60 or 90 days from baseline
Title
Waist-Hip Ratio (WHR)
Description
Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).
Time Frame
30, 60 or 90 days from baseline
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic and diastolic blood pressure measured.
Time Frame
30, 60 and 90 days from baseline
Title
Heart Rate
Description
Heart rate measured.
Time Frame
30, 60 and 90 days from baseline
Title
Quality of Life
Description
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.
Time Frame
30, 60 or 90 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Lewis, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami CRB
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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IgG-mediated Food Test for Weight Loss

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