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: NA

Last verified: May 2012

History: No changes posted

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:

Body composition [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Measures of body composition, including: height and weight to assess BMI and hip and waist circumference to calculate waist/hip ratio (WHR)

Secondary Outcome Measures:

Quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Quality of life measured with the SF-36 Health Survey

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: Non-reactive foods Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.	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.

Arms

Assigned Interventions

Experimental: Non-reactive foods

Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.

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 between 20 and 33 and who expressed 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

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

Publications:

Finn R, Smith MA, Youngs GR, Chew D, Johnson PM, Barnes RM. Immunological hypersensitivity to environmental antigens in the irritable bowel syndrome. Br J Clin Pract. 1987 Dec;41(12):1041-3.

Wilders-Truschnig M, Mangge H, Lieners C, Gruber H, Mayer C, März W. IgG antibodies against food antigens are correlated with inflammation and intima media thickness in obese juveniles. Exp Clin Endocrinol Diabetes. 2008 Apr;116(4):241-5. Epub 2007 Dec 10.

Kohno T, Kobashiri Y, Sugie Y, Takai S, Watabe K, Kaino Y, Kida K. Antibodies to food antigens in Japanese patients with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2002 Jan;55(1):1-9.

Pacor ML, Nicolis F, Cortina P, Peroli P, Venturini G, Andri L, Corrocher R, Lunardi C. [Migraine and food]. Recenti Prog Med. 1989 Feb;80(2):53-5. Italian.

Responsible Party:	John E. Lewis, Director of Research for Complementary and Integrative Medicine, University of Miami
ClinicalTrials.gov Identifier:	NCT01592071 History of Changes
Other Study ID Numbers:	20080670
Study First Received:	May 1, 2012
Last Updated:	May 1, 2012
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 May 19, 2013

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