Clinical trial NCT03821818: Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study
Official title: Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Food Hypersensitivity
Exercise
Lead sponsor: Galveston Clinical Research Foundation
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, obese subjects

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Weight
timeFrame: 90-days
Secondary outcomes:
measure: Change in Body Fat %
timeFrame: 90-days
measure: Change in Body Mass Index (BMI)
timeFrame: 90-days
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Galveston Clinical Research Foundation
state: Texas
Study officials:
affiliation: Galveston Clinical Research Foundation
name: Frank B Willis, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
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