An interventional study of Replace reactive foods with non-reactive foods in Overweight and Obesity, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-31.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 120 is above the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Weight (kg)
Measure of body composition: weight (kg).
Time frame: 30, 60 and 90 days from baseline
Body Mass Index
Measure of body composition: height and weight to assess BMI.
Time frame: 30, 60 and 90 days from baseline
Waist Circumference
Measure of body composition: waist circumference (cm).
Time frame: 30, 60 and 90 days from baseline
Hip Circumference
Measure of body composition: hip circumference (cm).
Time frame: 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).
Time frame: 30, 60 or 90 days from baseline
Blood Pressure
Systolic and diastolic blood pressure measured.
Time frame: 30, 60 and 90 days from baseline
Heart Rate
Heart rate measured.
Time frame: 30, 60 and 90 days from baseline
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
Recruitment between 2008 and 2010. Blood draws and discussion of results of blood draws performed at UM Clinical Research Building
| Milestone | Non-reactive Foods |
|---|---|
| Started | 120 |
| Completed | 120 |
| Not completed | 0 |
Measure of body composition: weight (kg).
| kilograms | Non-reactive Foods |
|---|---|
| Weight (Baseline) | 80 ± 17.2 |
| Weight (30 days) | 76.6 ± 15.8 |
| Weight (60 days) | 74.7 ± 16 |
| Weight (90 days) | 75 ± 17.7 |
Systolic and diastolic blood pressure measured.
| mm Hg | Non-reactive Foods |
|---|---|
| Systolic BP (Baseline) | 123.2 ± 17.2 |
| Systolic BP (30 days) | 119.0 ± 12.7 |
| Systolic BP (60 days) | 119.0 ± 15.1 |
| Systolic BP (90 days) | 115.7 ± 13.7 |
| Diastolic BP (Baseline) | 79.0 ± 12.1 |
| Diastolic BP (30 days) | 75.9 ± 9.1 |
| Diastolic BP (60 days) | 75.0 ± 9.6 |
| Diastolic BP (90 days) | 74.0 ± 7.3 |
Measure of body composition: height and weight to assess BMI.
| kg/m^2 | Non-reactive Foods |
|---|---|
| BMI (Baseline) | 29.0 ± 5.5 |
| BMI (30 days) | 27.7 ± 5.6 |
| BMI (60 days) | 27.4 ± 5.6 |
| BMI (90 days) | 27.2 ± 5.6 |
Measure of body composition: waist circumference (cm).
| centimeters | Non-reactive Foods |
|---|---|
| Waist Circumference (Baseline) | 91.7 ± 14.5 |
| Waist Circumference (30 days) | 85.9 ± 12.7 |
| Waist Circumference (60 days) | 85.1 ± 11.7 |
| Waist Circumference (90 days) | 84.3 ± 12.4 |
Heart rate measured.
| bpm | Non-reactive Foods |
|---|---|
| Heart Rate (Baseline) | 73.6 ± 10.7 |
| Heart Rate (30 days) | 72.1 ± 9.9 |
| Heart Rate (60 days) | 73.3 ± 8.9 |
| Heart Rate (90 days) | 72.5 ± 8.4 |
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.
| Scores on a scale | Non-reactive Foods |
|---|---|
| Physical Functioning (Baseline) | 86.5 ± 17.9 |
| Physical Functioning (30 days) | 91.8 ± 11.5 |
| Physical Functioning (60 days) | 91.7 ± 9.9 |
| Physical Functioning (90 days) | 93.8 ± 7.0 |
| Physical Role Functioning (Baseline) | 83.9 ± 21.4 |
| Physical Role Functioning (30 days) | 91.6 ± 16.5 |
| Physical Role Functioning (60 days) | 88.3 ± 14.1 |
| Physical Role Functioning (90 days) | 95.6 ± 6.1 |
| Emotional Role Functioning (Baseline) | 85.9 ± 19.2 |
| Emotional Role Functioning (30 days) | 91.7 ± 16.2 |
| Emotional Role Functioning (60 days) | 95.5 ± 9.5 |
| Emotional Role Functioning (90 days) | 93.3 ± 9.6 |
| Mental Health (Baseline) | 75.6 ± 15.9 |
| Mental Health (30 days) | 83.0 ± 15.1 |
| Mental Health (60 days) | 81.7 ± 12.7 |
| Mental Health (90 days) | 86.5 ± 10.1 |
| Social Functioning (Baseline) | 80.1 ± 22.8 |
| Social Functioning (30 days) | 87.5 ± 20.3 |
| Social Functioning (60 days) | 88.5 ± 14.2 |
| Social Functioning (90 days) | 94.4 ± 10.3 |
| Vitality (Baseline) | 57.7 ± 17.8 |
| Vitality (30 days) | 69.9 ± 16.2 |
| Vitality (60 days) | 68.0 ± 13.7 |
| Vitality (90 days) | 70.3 ± 14.7 |
| Bodily Pain (Baseline) | 67.3 ± 22.3 |
| Bodily Pain (30 days) | 78.4 ± 14.3 |
| Bodily Pain (60 days) | 79.4 ± 9.6 |
| Bodily Pain (90 days) | 78.5 ± 13.6 |
| General Health (Baseline) | 70.9 ± 19.6 |
| General Health (30 days) | 82.4 ± 13.8 |
| General Health (60 days) | 79.3 ± 13.4 |
| General Health (90 days) | 81.1 ± 11.0 |
Measure of body composition: hip circumference (cm).
| centimeters | Non-reactive Foods |
|---|---|
| Hip Circumference (Baseline) | 106.4 ± 11.4 |
| Hip Circumference (30 days) | 103.1 ± 12.4 |
| Hip Circumference (60 days) | 103.4 ± 13.5 |
| Hip Circumference (90 days) | 102.9 ± 11.2 |
Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).
| ratio | Non-reactive Foods |
|---|---|
| Waist-Hip Ratio (Baseline) | 0.86 ± 0.11 |
| Waist-Hip Ratio (30 days) | 0.84 ± 0.12 |
| Waist-Hip Ratio (60 days) | 0.83 ± 0.09 |
| Waist-Hip Ratio (90 days) | 0.82 ± 0.08 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-reactive Foods | — | 0/120 (0%) | 0/120 (0%) |
| Age, Categorical(Participants) | Non-reactive Foods |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 116 |
| >=65 years | 4 |
| Age, Continuous(years) | Non-reactive Foods |
|---|---|
| Mean | 45.5 ± 12.2 |
| Sex: Female, Male(Participants) | Non-reactive Foods |
|---|---|
| Female | 101 |
| Male | 19 |
| Region of Enrollment(participants) | Non-reactive Foods |
|---|---|
| United States | 120 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.