Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Immuno Laboratories | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Replace reactive w/ non-reactive foods | Experimental | Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (kg) | Measure of body composition: weight (kg). | 30, 60 and 90 days from baseline |
| Body Mass Index | Measure of body composition: height and weight to assess BMI. | 30, 60 and 90 days from baseline |
| Waist Circumference | Measure of body composition: waist circumference (cm). | 30, 60 and 90 days from baseline |
| Hip Circumference | Measure of body composition: hip circumference (cm). | 30, 60 or 90 days from baseline |
| Waist-Hip Ratio (WHR) | Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR). | 30, 60 or 90 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic and diastolic blood pressure measured. | 30, 60 and 90 days from baseline |
| Heart Rate | Heart rate measured. | 30, 60 and 90 days from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John E Lewis, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami CRB | Miami | Florida | 33136 | United States |
Not provided
Recruitment between 2008 and 2010. Blood draws and discussion of results of blood draws performed at UM Clinical Research Building
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight (kg) | Measure of body composition: weight (kg). | Posted | Mean | Standard Deviation | kilograms | 30, 60 and 90 days from baseline |
|
|
Not provided
Serious or Other (non-serious) Adverse Events were collected/assessed, but none observed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Lewis | University of Miami | (305) 243-6227 | jelewis@miami.edu |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000073923 | Food Intolerance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 30, 60 or 90 days from baseline |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Blood Pressure | Systolic and diastolic blood pressure measured. | Posted | Mean | Standard Deviation | mm Hg | 30, 60 and 90 days from baseline |
|
|
|
| Primary | Body Mass Index | Measure of body composition: height and weight to assess BMI. | Posted | Mean | Standard Deviation | kg/m^2 | 30, 60 and 90 days from baseline |
|
|
|
| Primary | Waist Circumference | Measure of body composition: waist circumference (cm). | Posted | Mean | Standard Deviation | centimeters | 30, 60 and 90 days from baseline |
|
|
|
| Secondary | Heart Rate | Heart rate measured. | Posted | Mean | Standard Deviation | bpm | 30, 60 and 90 days from baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 30, 60 or 90 days from baseline |
|
|
|
| Primary | Hip Circumference | Measure of body composition: hip circumference (cm). | Posted | Mean | Standard Deviation | centimeters | 30, 60 or 90 days from baseline |
|
|
|
| Primary | Waist-Hip Ratio (WHR) | Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR). | Posted | Mean | Standard Deviation | ratio | 30, 60 or 90 days from baseline |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| Title | Measurements |
|---|---|
|
| Systolic BP (90 days) |
|
| Diastolic BP (Baseline) |
|
| Diastolic BP (30 days) |
|
| Diastolic BP (60 days) |
|
| Diastolic BP (90 days) |
|
|
| BMI (90 days) |
|
| Title | Measurements |
|---|---|
|
| Waist Circumference (90 days) |
|
| Title | Measurements |
|---|---|
|
| Heart Rate (90 days) |
|
|
| Physical Functioning (90 days) |
|
| Physical Role Functioning (Baseline) |
|
| Physical Role Functioning (30 days) |
|
| Physical Role Functioning (60 days) |
|
| Physical Role Functioning (90 days) |
|
| Emotional Role Functioning (Baseline) |
|
| Emotional Role Functioning (30 days) |
|
| Emotional Role Functioning (60 days) |
|
| Emotional Role Functioning (90 days) |
|
| Mental Health (Baseline) |
|
| Mental Health (30 days) |
|
| Mental Health (60 days) |
|
| Mental Health (90 days) |
|
| Social Functioning (Baseline) |
|
| Social Functioning (30 days) |
|
| Social Functioning (60 days) |
|
| Social Functioning (90 days) |
|
| Vitality (Baseline) |
|
| Vitality (30 days) |
|
| Vitality (60 days) |
|
| Vitality (90 days) |
|
| Bodily Pain (Baseline) |
|
| Bodily Pain (30 days) |
|
| Bodily Pain (60 days) |
|
| Bodily Pain (90 days) |
|
| General Health (Baseline) |
|
| General Health (30 days) |
|
| General Health (60 days) |
|
| General Health (90 days) |
|
| Title | Measurements |
|---|---|
|
| Hip Circumference (90 days) |
|
|
| Waist-Hip Ratio (90 days) |
|