Overweight and ObesityNCT01592071
IgG-mediated Food Test for Weight Loss
A study testing Replace reactive foods with non-reactive foods in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Replace reactive foods with non-reactive foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI above 20
- Express an interest in losing weight
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Replace reactive foods with non-reactive foods
- Keywords
- food sensitivity, IgG, obesity, overweight, body composition, reactive foods
- Medical subject headings
- Overweight, Obesity, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replace reactive foods with non-reactive foodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Replace reactive w/ non-reactive foods | Experimental | Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods' Receives: Other: Replace reactive foods with non-reactive foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
Measure of body composition: weight (kg).
Measured: 30, 60 and 90 days from baseline
Body Mass Index
Measure of body composition: height and weight to assess BMI.
Measured: 30, 60 and 90 days from baseline
Waist Circumference
Measure of body composition: waist circumference (cm).
Measured: 30, 60 and 90 days from baseline
Hip Circumference
Measure of body composition: hip circumference (cm).
Measured: 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).
Measured: 30, 60 or 90 days from baseline
Secondary outcomes (3)
Blood Pressure
Systolic and diastolic blood pressure measured.
Measured: 30, 60 and 90 days from baseline
Heart Rate
Heart rate measured.
Measured: 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.
Measured: 30, 60 or 90 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Immuno Laboratories
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John E Lewis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592071
- Sponsor's protocol ID
- 20080670
- Status last verified
- Feb 2014
- First submitted
- 1 May 2012
- Last updated
- 31 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons
- ClinicalTrials.gov ID
- NCT01592071
- Acronym / sponsor ID
- 20080670
- Conditions
- Overweight and Obesity
- Keywords
- food sensitivity, IgG, obesity, overweight, body composition, reactive foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Immuno Laboratories
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replace reactive w/ non-reactive foods | Experimental | Other: Replace reactive foods with non-reactive foodsTest results, individual dietary plan: 'Replace reactive foods with non-reactive foods' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI above 20
- Express an interest in losing weight
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replace reactive foods with non-reactive foodsSubjects 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. | Other | Replace reactive w/ non-reactive foods |
Primary outcome
Weight (kg)
Time frame: 30, 60 and 90 days from baseline
Measure of body composition: weight (kg).
Body Mass Index
Time frame: 30, 60 and 90 days from baseline
Measure of body composition: height and weight to assess BMI.
Waist Circumference
Time frame: 30, 60 and 90 days from baseline
Measure of body composition: waist circumference (cm).
Hip Circumference
Time frame: 30, 60 or 90 days from baseline
Measure of body composition: hip circumference (cm).
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).
3 secondary outcomes
Blood Pressure
Time frame: 30, 60 and 90 days from baseline
Heart Rate
Time frame: 30, 60 and 90 days from baseline
Quality of Life
Time frame: 30, 60 or 90 days from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Lewis, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replace reactive foods with non-reactive foods in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (kg) (time frame: 30, 60 and 90 days from baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.