Overweight and Obesity
Conditions
Keywords
food sensitivity, IgG, obesity, overweight, body composition, reactive foods
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.
Interventions
OTHERReplace 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.
Sponsors
Immuno Laboratories
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist-Hip Ratio (WHR) | 30, 60 or 90 days from baseline | Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR). |
| Body Mass Index | 30, 60 and 90 days from baseline | Measure of body composition: height and weight to assess BMI. |
| Waist Circumference | 30, 60 and 90 days from baseline | Measure of body composition: waist circumference (cm). |
| Hip Circumference | 30, 60 or 90 days from baseline | Measure of body composition: hip circumference (cm). |
| Weight (kg) | 30, 60 and 90 days from baseline | Measure of body composition: weight (kg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 30, 60 and 90 days from baseline | Heart rate measured. |
| Quality of Life | 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. |
| Blood Pressure | 30, 60 and 90 days from baseline | Systolic and diastolic blood pressure measured. |
Countries
United States
Participant flow
Recruitment details
Recruitment between 2008 and 2010. Blood draws and discussion of results of blood draws performed at UM Clinical Research Building
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Non-reactive Foods |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants |
| Age, Continuous | 45.5 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 120 participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Body Mass Index
Measure of body composition: height and weight to assess BMI.
Time frame: 30, 60 and 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Body Mass Index | BMI (90 days) | 27.2 kg/m^2 | Standard Deviation 5.6 |
| Non-reactive Foods | Body Mass Index | BMI (Baseline) | 29.0 kg/m^2 | Standard Deviation 5.5 |
| Non-reactive Foods | Body Mass Index | BMI (30 days) | 27.7 kg/m^2 | Standard Deviation 5.6 |
| Non-reactive Foods | Body Mass Index | BMI (60 days) | 27.4 kg/m^2 | Standard Deviation 5.6 |
Primary
Hip Circumference
Measure of body composition: hip circumference (cm).
Time frame: 30, 60 or 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Hip Circumference | Hip Circumference (60 days) | 103.4 centimeters | Standard Deviation 13.5 |
| Non-reactive Foods | Hip Circumference | Hip Circumference (Baseline) | 106.4 centimeters | Standard Deviation 11.4 |
| Non-reactive Foods | Hip Circumference | Hip Circumference (30 days) | 103.1 centimeters | Standard Deviation 12.4 |
| Non-reactive Foods | Hip Circumference | Hip Circumference (90 days) | 102.9 centimeters | Standard Deviation 11.2 |
Primary
Waist Circumference
Measure of body composition: waist circumference (cm).
Time frame: 30, 60 and 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Waist Circumference | Waist Circumference (Baseline) | 91.7 centimeters | Standard Deviation 14.5 |
| Non-reactive Foods | Waist Circumference | Waist Circumference (30 days) | 85.9 centimeters | Standard Deviation 12.7 |
| Non-reactive Foods | Waist Circumference | Waist Circumference (60 days) | 85.1 centimeters | Standard Deviation 11.7 |
| Non-reactive Foods | Waist Circumference | Waist Circumference (90 days) | 84.3 centimeters | Standard Deviation 12.4 |
Primary
Waist-Hip Ratio (WHR)
Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).
Time frame: 30, 60 or 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Waist-Hip Ratio (WHR) | Waist-Hip Ratio (Baseline) | 0.86 ratio | Standard Deviation 0.11 |
| Non-reactive Foods | Waist-Hip Ratio (WHR) | Waist-Hip Ratio (30 days) | 0.84 ratio | Standard Deviation 0.12 |
| Non-reactive Foods | Waist-Hip Ratio (WHR) | Waist-Hip Ratio (60 days) | 0.83 ratio | Standard Deviation 0.09 |
| Non-reactive Foods | Waist-Hip Ratio (WHR) | Waist-Hip Ratio (90 days) | 0.82 ratio | Standard Deviation 0.08 |
Primary
Weight (kg)
Measure of body composition: weight (kg).
Time frame: 30, 60 and 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Weight (kg) | Weight (Baseline) | 80 kilograms | Standard Deviation 17.2 |
| Non-reactive Foods | Weight (kg) | Weight (30 days) | 76.6 kilograms | Standard Deviation 15.8 |
| Non-reactive Foods | Weight (kg) | Weight (60 days) | 74.7 kilograms | Standard Deviation 16 |
| Non-reactive Foods | Weight (kg) | Weight (90 days) | 75 kilograms | Standard Deviation 17.7 |
Secondary
Blood Pressure
Systolic and diastolic blood pressure measured.
Time frame: 30, 60 and 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Blood Pressure | Systolic BP (Baseline) | 123.2 mm Hg | Standard Deviation 17.2 |
| Non-reactive Foods | Blood Pressure | Systolic BP (30 days) | 119.0 mm Hg | Standard Deviation 12.7 |
| Non-reactive Foods | Blood Pressure | Systolic BP (60 days) | 119.0 mm Hg | Standard Deviation 15.1 |
| Non-reactive Foods | Blood Pressure | Systolic BP (90 days) | 115.7 mm Hg | Standard Deviation 13.7 |
| Non-reactive Foods | Blood Pressure | Diastolic BP (Baseline) | 79.0 mm Hg | Standard Deviation 12.1 |
| Non-reactive Foods | Blood Pressure | Diastolic BP (30 days) | 75.9 mm Hg | Standard Deviation 9.1 |
| Non-reactive Foods | Blood Pressure | Diastolic BP (60 days) | 75.0 mm Hg | Standard Deviation 9.6 |
| Non-reactive Foods | Blood Pressure | Diastolic BP (90 days) | 74.0 mm Hg | Standard Deviation 7.3 |
Secondary
Heart Rate
Heart rate measured.
Time frame: 30, 60 and 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Heart Rate | Heart Rate (Baseline) | 73.6 bpm | Standard Deviation 10.7 |
| Non-reactive Foods | Heart Rate | Heart Rate (30 days) | 72.1 bpm | Standard Deviation 9.9 |
| Non-reactive Foods | Heart Rate | Heart Rate (60 days) | 73.3 bpm | Standard Deviation 8.9 |
| Non-reactive Foods | Heart Rate | Heart Rate (90 days) | 72.5 bpm | Standard Deviation 8.4 |
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.
Time frame: 30, 60 or 90 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-reactive Foods | Quality of Life | Physical Functioning (Baseline) | 86.5 Scores on a scale | Standard Deviation 17.9 |
| Non-reactive Foods | Quality of Life | Physical Functioning (30 days) | 91.8 Scores on a scale | Standard Deviation 11.5 |
| Non-reactive Foods | Quality of Life | Physical Functioning (60 days) | 91.7 Scores on a scale | Standard Deviation 9.9 |
| Non-reactive Foods | Quality of Life | Physical Functioning (90 days) | 93.8 Scores on a scale | Standard Deviation 7 |
| Non-reactive Foods | Quality of Life | Physical Role Functioning (Baseline) | 83.9 Scores on a scale | Standard Deviation 21.4 |
| Non-reactive Foods | Quality of Life | Physical Role Functioning (30 days) | 91.6 Scores on a scale | Standard Deviation 16.5 |
| Non-reactive Foods | Quality of Life | Physical Role Functioning (60 days) | 88.3 Scores on a scale | Standard Deviation 14.1 |
| Non-reactive Foods | Quality of Life | Physical Role Functioning (90 days) | 95.6 Scores on a scale | Standard Deviation 6.1 |
| Non-reactive Foods | Quality of Life | Emotional Role Functioning (Baseline) | 85.9 Scores on a scale | Standard Deviation 19.2 |
| Non-reactive Foods | Quality of Life | Emotional Role Functioning (30 days) | 91.7 Scores on a scale | Standard Deviation 16.2 |
| Non-reactive Foods | Quality of Life | Emotional Role Functioning (60 days) | 95.5 Scores on a scale | Standard Deviation 9.5 |
| Non-reactive Foods | Quality of Life | Emotional Role Functioning (90 days) | 93.3 Scores on a scale | Standard Deviation 9.6 |
| Non-reactive Foods | Quality of Life | Mental Health (Baseline) | 75.6 Scores on a scale | Standard Deviation 15.9 |
| Non-reactive Foods | Quality of Life | Mental Health (30 days) | 83.0 Scores on a scale | Standard Deviation 15.1 |
| Non-reactive Foods | Quality of Life | Mental Health (60 days) | 81.7 Scores on a scale | Standard Deviation 12.7 |
| Non-reactive Foods | Quality of Life | Mental Health (90 days) | 86.5 Scores on a scale | Standard Deviation 10.1 |
| Non-reactive Foods | Quality of Life | Social Functioning (Baseline) | 80.1 Scores on a scale | Standard Deviation 22.8 |
| Non-reactive Foods | Quality of Life | Social Functioning (30 days) | 87.5 Scores on a scale | Standard Deviation 20.3 |
| Non-reactive Foods | Quality of Life | Social Functioning (60 days) | 88.5 Scores on a scale | Standard Deviation 14.2 |
| Non-reactive Foods | Quality of Life | Social Functioning (90 days) | 94.4 Scores on a scale | Standard Deviation 10.3 |
| Non-reactive Foods | Quality of Life | Vitality (Baseline) | 57.7 Scores on a scale | Standard Deviation 17.8 |
| Non-reactive Foods | Quality of Life | Vitality (30 days) | 69.9 Scores on a scale | Standard Deviation 16.2 |
| Non-reactive Foods | Quality of Life | Vitality (60 days) | 68.0 Scores on a scale | Standard Deviation 13.7 |
| Non-reactive Foods | Quality of Life | Vitality (90 days) | 70.3 Scores on a scale | Standard Deviation 14.7 |
| Non-reactive Foods | Quality of Life | Bodily Pain (Baseline) | 67.3 Scores on a scale | Standard Deviation 22.3 |
| Non-reactive Foods | Quality of Life | Bodily Pain (30 days) | 78.4 Scores on a scale | Standard Deviation 14.3 |
| Non-reactive Foods | Quality of Life | Bodily Pain (60 days) | 79.4 Scores on a scale | Standard Deviation 9.6 |
| Non-reactive Foods | Quality of Life | Bodily Pain (90 days) | 78.5 Scores on a scale | Standard Deviation 13.6 |
| Non-reactive Foods | Quality of Life | General Health (Baseline) | 70.9 Scores on a scale | Standard Deviation 19.6 |
| Non-reactive Foods | Quality of Life | General Health (30 days) | 82.4 Scores on a scale | Standard Deviation 13.8 |
| Non-reactive Foods | Quality of Life | General Health (60 days) | 79.3 Scores on a scale | Standard Deviation 13.4 |
| Non-reactive Foods | Quality of Life | General Health (90 days) | 81.1 Scores on a scale | Standard Deviation 11 |