Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study

Study Overview
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Brief Summary
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Screened subjects will be tested for hidden food allergies. Subjects will eliminate all food that showed leukocyte reactions for 90-days. Subjects will then also be invited to use the Willis Exercise protocol. Body composition testing and Body Mass Index calculation will be accomplished at enrollment and after completion of the 90-day study.

Detailed Description
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Subjects will first be screened for cardiovascular pathologies and then tested for hidden food allergies. After the results subjects will eliminate all food that showed leukocyte reactions for 90-days. Subjects will then also be invited to use the Willis Exercise protocol (Aerobic-surge exercise > 75% max heart rate, for 2-minutes, 5/day. Body composition testing and Body Mass Index calculation will be accomplished at enrollment and after completion of the 90-day study.

Official Title
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Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Food Allergy Elimination + Willis Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is > 20 years of age and is willing and able to provide signed informed consent. The subject has a BMI > 30. The subject is between the ages of 20 to 75 years of age. Exclusion Criteria: Cardiovascular Heart Disease and this includes but is not limited to history of myocardial infarction, atrial fibrillation, etc. History of cerebral vascular event (stroke), traumatic brain injury, Parkinson's disease or any other neural injury or disease. Diabetes Mellitus (Type I or II) Pregnancy Participation in any other weight loss protocols, diets, or medication.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Food Allergen Elimination only | |
| Allergen Elimination + Willis Exercise<br>Subjects will have food allergens eliminated and also perform Aerobic-surge, brief high intensity exercise > 75% max HR), five times/day. | Behavioral: Food Allergy Elimination + Willis Exercise<br>* Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)<br>* Other names: Willis exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | measure Kg | 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat % | Percentage of fat vs lean mass | 90-days | 
| Change in Body Mass Index (BMI) | BMI calculation | 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Hypersensitivity, Exercise