- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03821818
Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study
January 28, 2019 updated by: Galveston Clinical Research Foundation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77551
- Recruiting
- Galveston Clinical Research Foundation
-
Contact:
- Dr FB Willis, MBBS, PhD
- Phone Number: 409-457-7894
- Email: DocWillis@yahoo.com
-
Contact:
- Tina West, RN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy, obese subjects
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: 90-days
|
measure Kg
|
90-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Fat %
Time Frame: 90-days
|
Percentage of fat vs lean mass
|
90-days
|
Change in Body Mass Index (BMI)
Time Frame: 90-days
|
BMI calculation
|
90-days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frank B Willis, MBBS, PhD, Galveston Clinical Research Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
- Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.
- Alpay K, Ertas M, Orhan EK, Ustay DK, Lieners C, Baykan B. Diet restriction in migraine, based on IgG against foods: a clinical double-blind, randomised, cross-over trial. Cephalalgia. 2010 Jul;30(7):829-37. doi: 10.1177/0333102410361404. Epub 2010 Mar 10.
- Aydinlar EI, Dikmen PY, Tiftikci A, Saruc M, Aksu M, Gunsoy HG, Tozun N. IgG-based elimination diet in migraine plus irritable bowel syndrome. Headache. 2013 Mar;53(3):514-25. doi: 10.1111/j.1526-4610.2012.02296.x. Epub 2012 Dec 6.
- Kesman RL, Ebbert JO, Harris KI, Schroeder DR. Portion control for the treatment of obesity in the primary care setting. BMC Res Notes. 2011 Sep 9;4:346. doi: 10.1186/1756-0500-4-346.
- Torbahn G, Gellhaus I, Koch B, von Kries R, Obermeier V, Holl RW, Fink K, van Egmond-Frohlich A. Reduction of Portion Size and Eating Rate Is Associated with BMI-SDS Reduction in Overweight and Obese Children and Adolescents: Results on Eating and Nutrition Behaviour from the Observational KgAS Study. Obes Facts. 2017;10(5):503-516. doi: 10.1159/000480517. Epub 2017 Oct 31.
- Iwao S, Mori K, Sato Y. Effects of meal frequency on body composition during weight control in boxers. Scand J Med Sci Sports. 1996 Oct;6(5):265-72. doi: 10.1111/j.1600-0838.1996.tb00469.x.
- Harris NK, Dulson DK, Logan GRM, Warbrick IB, Merien FLR, Lubans DR. Acute Responses to Resistance and High-Intensity Interval Training in Early Adolescents. J Strength Cond Res. 2017 May;31(5):1177-1186. doi: 10.1519/JSC.0000000000001590.
- Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. doi: 10.1001/jama.289.3.323.
- Jakicic JM, Otto AD. Treatment and prevention of obesity: what is the role of exercise? Nutr Rev. 2006 Feb;64(2 Pt 2):S57-61. doi: 10.1111/j.1753-4887.2006.tb00235.x.
- Sijie T, Hainai Y, Fengying Y, Jianxiong W. High intensity interval exercise training in overweight young women. J Sports Med Phys Fitness. 2012 Jun;52(3):255-62.
- Stoner L, Rowlands D, Morrison A, Credeur D, Hamlin M, Gaffney K, Lambrick D, Matheson A. Efficacy of Exercise Intervention for Weight Loss in Overweight and Obese Adolescents: Meta-Analysis and Implications. Sports Med. 2016 Nov;46(11):1737-1751. doi: 10.1007/s40279-016-0537-6.
- Willis FB, Smith FM, Willis AP. Frequency of exercise for body fat loss: a controlled, cohort study. J Strength Cond Res. 2009 Nov;23(8):2377-80. doi: 10.1519/JSC.0b013e3181b8d4e8.
- Poulsen SK, Due A, Jordy AB, Kiens B, Stark KD, Stender S, Holst C, Astrup A, Larsen TM. Health effect of the New Nordic Diet in adults with increased waist circumference: a 6-mo randomized controlled trial. Am J Clin Nutr. 2014 Jan;99(1):35-45. doi: 10.3945/ajcn.113.069393. Epub 2013 Nov 20.
- Palmer DJ, Huang RC, Craig JM, Prescott SL. Nutritional influences on epigenetic programming: asthma, allergy, and obesity. Immunol Allergy Clin North Am. 2014 Nov;34(4):825-37. doi: 10.1016/j.iac.2014.07.003. Epub 2014 Aug 21.
- Hurtado-Barroso S, Tresserra-Rimbau A, Vallverdu-Queralt A, Lamuela-Raventos RM. Organic food and the impact on human health. Crit Rev Food Sci Nutr. 2019;59(4):704-714. doi: 10.1080/10408398.2017.1394815. Epub 2017 Nov 30.
- Pergola G, Foroni F, Mengotti P, Argiris G, Rumiati RI. A neural signature of food semantics is associated with body-mass index. Biol Psychol. 2017 Oct;129:282-292. doi: 10.1016/j.biopsycho.2017.09.001. Epub 2017 Sep 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2018
Primary Completion (Actual)
August 15, 2018
Study Completion (Anticipated)
August 30, 2019
Study Registration Dates
First Submitted
May 31, 2018
First Submitted That Met QC Criteria
January 28, 2019
First Posted (Actual)
January 30, 2019
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Food Allergy Elimination + Willis Exercise
-
The R2 InstituteUnknownVocal Cord Tension | Dysfluency DevelopmentalUnited States
-
Central Hospital, Nancy, FranceCompleted
-
Boston Children's HospitalMcMaster UniversityCompletedEvaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food AllergyHypersensitivity, FoodUnited States
-
Kent State UniversityRhode Island Hospital; University of MemphisCompletedChild, Only | Allergy;Food | Adherence, TreatmentUnited States
-
Children's National Research InstituteNational Institute of Allergy and Infectious Diseases (NIAID); Northwestern... and other collaboratorsRecruiting
-
Federico II UniversityRecruitingNon IgE Mediated Food Allergy | Food Protein-Induced Enteropathy | Food Protein-Induced Proctocolitis | Food Protein-Induced Enterocolitis Syndrome | Food Protein-induced Motility DisordersItaly
-
Children's Health IrelandCompletedImpact of an Educational Tool on Quality of Life and Anxiety in Parents of Children With Nut AllergyFood Allergy | Child AllergyIreland
-
University of Colorado, DenverNorthwestern University; Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawnEosinophilic Esophagitis