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Completed

NCT Number: NCT01592071

IgG-mediated Food Test for Weight Loss

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.

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Key information

Conditions

Overweight and Obesity Body Weight Food Intolerance Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami CRB

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Replace reactive foods with non-reactive foods

Other

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 outcomes

  1. Weight (kg)

    Time frame: 30, 60 and 90 days from baseline

    Measure of body composition: weight (kg).

  2. Body Mass Index

    Time frame: 30, 60 and 90 days from baseline

    Measure of body composition: height and weight to assess BMI.

  3. Waist Circumference

    Time frame: 30, 60 and 90 days from baseline

    Measure of body composition: waist circumference (cm).

  4. Hip Circumference

    Time frame: 30, 60 or 90 days from baseline

    Measure of body composition: hip circumference (cm).

  5. Waist-Hip Ratio (WHR)

    Time frame: 30, 60 or 90 days from baseline

    Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).

Secondary outcomes

  1. Blood Pressure

    Time frame: 30, 60 and 90 days from baseline

    Systolic and diastolic blood pressure measured.

  2. Heart Rate

    Time frame: 30, 60 and 90 days from baseline

    Heart rate measured.

  3. Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Immuno Laboratories

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 7, 2012
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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