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

• Conditions: Obesity
• Interventions: Behavioral: Food Allergy Elimination + Willis Exercise

• Registration Number: NCT03821818
• Lead Sponsor: Galveston Clinical Research Foundation

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2018-05-31
• Primary Completion: 2018-08-15
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. The subject is > 20 years of age and is willing and able to provide signed informed consent.
2. The subject has a BMI > 30.
3. The subject is between the ages of 20 to 75 years of age.

Exclusion Criteria

1. Cardiovascular Heart Disease and this includes but is not limited to history of myocardial infarction, atrial fibrillation, etc.
2. History of cerebral vascular event (stroke), traumatic brain injury, Parkinson's disease or any other neural injury or disease.
3. Diabetes Mellitus (Type I or II)
4. Pregnancy
5. Participation in any other weight loss protocols, diets, or medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergen Elimination + Willis Exercise	Food Allergy Elimination + Willis Exercise	Subjects will have food allergens eliminated and also perform Aerobic-surge, brief high intensity exercise \> 75% max HR), five times/day.

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	90-days	measure Kg

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI)	90-days	BMI calculation
Change in Body Fat %	90-days	Percentage of fat vs lean mass

Trial Locations

Locations (1)

Galveston Clinical Research Foundation; 🇺🇸 Galveston, Texas, United States