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

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ClinicalTrials.gov Identifier: NCT03821818
Recruitment Status : Unknown
Verified January 2019 by Galveston Clinical Research Foundation.
Recruitment status was:  Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Galveston Clinical Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment
Obesity Behavioral: Food Allergy Elimination + Willis Exercise

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : August 15, 2018
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Control
Food Allergen Elimination only
Allergen Elimination + Willis Exercise
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
Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)
Other Name: Willis exercise


Outcome Measures
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Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: 90-days ]
    measure Kg


Secondary Outcome Measures :
  1. Change in Body Fat % [ Time Frame: 90-days ]
    Percentage of fat vs lean mass

  2. Change in Body Mass Index (BMI) [ Time Frame: 90-days ]
    BMI calculation


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, obese subjects
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821818


Contacts
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Contact: Frank B Willis, MBBS, PhD 409-457-7894 DocWillis@yahoo.com
Contact: Tina West RN, RN 888-621-5557 TinaWestRN@yahoo.com

Locations
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United States, Texas
Galveston Clinical Research Foundation Recruiting
Galveston, Texas, United States, 77551
Contact: Dr FB Willis, MBBS, PhD    409-457-7894    DocWillis@yahoo.com   
Contact: Tina West, RN         
Sponsors and Collaborators
Galveston Clinical Research Foundation
Investigators
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Principal Investigator: Frank B Willis, MBBS, PhD Galveston Clinical Research Foundation
  Study Documents (Full-Text)

Documents provided by Galveston Clinical Research Foundation:
Study Protocol  [PDF] February 1, 2018

More Information
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Publications:

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Responsible Party: Galveston Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT03821818    
Other Study ID Numbers: 2018.04
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galveston Clinical Research Foundation:
Food Hypersensitivity
Exercise
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight