IgG-mediated Food Test for Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Immuno Laboratories
Information provided by (Responsible Party):
John E. Lewis, University of Miami
ClinicalTrials.gov Identifier:
NCT01592071
First received: May 1, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Overweight and Obesity
Other: Replace reactive foods with non-reactive foods

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Weight (kg) [ Time Frame: 30, 60 and 90 days from baseline ] [ Designated as safety issue: No ]
    Measure of body composition: weight (kg).

  • Body Mass Index [ Time Frame: 30, 60 and 90 days from baseline ] [ Designated as safety issue: No ]
    Measure of body composition: height and weight to assess BMI.

  • Waist Circumference [ Time Frame: 30, 60 and 90 days from baseline ] [ Designated as safety issue: No ]
    Measure of body composition: waist circumference (cm).

  • Hip Circumference [ Time Frame: 30, 60 or 90 days from baseline ] [ Designated as safety issue: No ]
    Measure of body composition: hip circumference (cm).

  • Waist-Hip Ratio (WHR) [ Time Frame: 30, 60 or 90 days from baseline ] [ Designated as safety issue: No ]
    Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 30, 60 and 90 days from baseline ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure measured.

  • Heart Rate [ Time Frame: 30, 60 and 90 days from baseline ] [ Designated as safety issue: No ]
    Heart rate measured.

  • Quality of Life [ Time Frame: 30, 60 or 90 days from baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592071

Locations
United States, Florida
University of Miami CRB
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Immuno Laboratories
Investigators
Principal Investigator: John E Lewis, PhD University of Miami
  More Information

No publications provided

Responsible Party: John E. Lewis, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01592071     History of Changes
Other Study ID Numbers: 20080670
Study First Received: May 1, 2012
Results First Received: August 23, 2012
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
food sensitivity
IgG
obesity
overweight
body composition
reactive foods

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014