Recruiting

Food Allergen Eliminations

Sponsor:

Galveston Clinical Research Foundation

Code:

NCT03821818

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Food Allergy Elimination + Willis Exercise

Study Details

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.

Conditions

Obesity

Study ID

NCT03821818

Start date

Mar 5, 2018

Status verified date

Jan, 2019

Completion date

Aug 30, 2019

Anticipated

Primary completion date

Aug 15, 2018

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Food Allergy Elimination + Willis Exercise

Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)

Primary outcome measure

  • Change in Body Weight [ Time Frame: 90-days ]

Central Contacts and Locations

Central contacts

Frank B Willis, MBBS, PhD

409-457-7894DocWillis@yahoo.com

Tina West RN, RN

888-621-5557TinaWestRN@yahoo.com

Locations

Galveston Clinical Research Foundation

Recruiting

Galveston, Texas, United States, 77551

Contacts

Dr FB Willis, MBBS, PhD

409-457-7894DocWillis@yahoo.com

More Information

Sponsor

Galveston Clinical Research Foundation

Last update posted

Jan 30, 2019

Last verified

Jan, 2019

Keywords

  • Food Hypersensitivity
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Galveston Clinical Research Foundation on 2019-01-30.