Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study
NCT ID: NCT03821818
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2018-03-05
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control
Food Allergen Elimination only
No interventions assigned to this group
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
Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise \> 75% max heart rate, 5/day)
Interventions
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Food Allergy Elimination + Willis Exercise
Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise \> 75% max heart rate, 5/day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject has a BMI \> 30.
3. The subject is between the ages of 20 to 75 years of age.
Exclusion Criteria
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.
20 Years
75 Years
ALL
Yes
Sponsors
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Galveston Clinical Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Frank B Willis, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Galveston Clinical Research Foundation
Locations
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Galveston Clinical Research Foundation
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Tina West, RN
Role: backup
References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2018.04
Identifier Type: -
Identifier Source: org_study_id
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