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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821818
• Other study ID #: 2018.04
• Status: Recruiting
• Start date: March 5, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2019
• Source: Galveston Clinical Research Foundation
• Contact: Frank B Willis, MBBS, PhD
• Phone: 409-457-7894
• Email: DocWillis[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2019
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Galveston Clinical Research Foundation	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galveston Clinical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hurtado-Barroso S, Tresserra-Rimbau A, Vallverdú-Queralt A, Lamuela-Raventós RM. Organic food and the impact on human health. Crit Rev Food Sci Nutr. 2017 Nov 30:1-11. doi: 10.1080/10408398.2017.1394815. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Torbahn G, Gellhaus I, Koch B, von Kries R, Obermeier V, Holl RW, Fink K, van Egmond-Fröhlich 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. — View Citation

Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	measure Kg	90-days
Secondary	Change in Body Fat %	Percentage of fat vs lean mass	90-days
Secondary	Change in Body Mass Index (BMI)	BMI calculation	90-days