NCT01592071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 31, 2014

Completed
Last Updated

March 31, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

May 1, 2012

Results QC Date

August 23, 2012

Last Update Submit

February 14, 2014

Conditions

Overweight and Obesity

Keywords

food sensitivityIgGobesityoverweightbody compositionreactive foods

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (3)

  • Blood Pressure

    30, 60 and 90 days from baseline

  • Heart Rate

    30, 60 and 90 days from baseline

  • Quality of Life

    30, 60 or 90 days from baseline

Study Arms (1)

Replace reactive w/ non-reactive foods

EXPERIMENTAL

Test results, individual dietary plan: 'Replace reactive foods with non-reactive foods'

Other: Replace reactive foods with non-reactive foods

Interventions

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.

Replace reactive w/ non-reactive foods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI above 20
  • Express an interest in losing weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami CRB

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

OverweightObesityFood Intolerance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Results Point of Contact

Title
Dr. John Lewis
Organization
University of Miami
jelewis@miami.edu
(305) 243-6227

Study Officials

  • John E Lewis, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 7, 2012

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 31, 2014

Results First Posted

March 31, 2014

Record last verified: 2014-02

Locations

US(1)