<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821818</url>
  </required_header>
  <id_info>
    <org_study_id>2018.04</org_study_id>
    <nct_id>NCT03821818</nct_id>
  </id_info>
  <brief_title>Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study</brief_title>
  <official_title>Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galveston Clinical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galveston Clinical Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Screened subjects will be tested for hidden food allergies. Subjects will eliminate all food&#xD;
      that showed leukocyte reactions for 90-days. Subjects will then also be invited to use the&#xD;
      Willis Exercise protocol. Body composition testing and Body Mass Index calculation will be&#xD;
      accomplished at enrollment and after completion of the 90-day study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will first be screened for cardiovascular pathologies and then tested for hidden&#xD;
      food allergies. After the results subjects will eliminate all food that showed leukocyte&#xD;
      reactions for 90-days. Subjects will then also be invited to use the Willis Exercise protocol&#xD;
      (Aerobic-surge exercise &gt; 75% max heart rate, for 2-minutes, 5/day. Body composition testing&#xD;
      and Body Mass Index calculation will be accomplished at enrollment and after completion of&#xD;
      the 90-day study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>90-days</time_frame>
    <description>measure Kg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Fat %</measure>
    <time_frame>90-days</time_frame>
    <description>Percentage of fat vs lean mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>90-days</time_frame>
    <description>BMI calculation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Food Allergen Elimination only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allergen Elimination + Willis Exercise</arm_group_label>
    <description>Subjects will have food allergens eliminated and also perform Aerobic-surge, brief high intensity exercise &gt; 75% max HR), five times/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Food Allergy Elimination + Willis Exercise</intervention_name>
    <description>Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise &gt; 75% max heart rate, 5/day)</description>
    <arm_group_label>Allergen Elimination + Willis Exercise</arm_group_label>
    <other_name>Willis exercise</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy, obese subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is &gt; 20 years of age and is willing and able to provide signed informed&#xD;
             consent.&#xD;
&#xD;
          2. The subject has a BMI &gt; 30.&#xD;
&#xD;
          3. The subject is between the ages of 20 to 75 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiovascular Heart Disease and this includes but is not limited to history of&#xD;
             myocardial infarction, atrial fibrillation, etc.&#xD;
&#xD;
          2. History of cerebral vascular event (stroke), traumatic brain injury, Parkinson's&#xD;
             disease or any other neural injury or disease.&#xD;
&#xD;
          3. Diabetes Mellitus (Type I or II)&#xD;
&#xD;
          4. Pregnancy&#xD;
&#xD;
          5. Participation in any other weight loss protocols, diets, or medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank B Willis, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Galveston Clinical Research Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank B Willis, MBBS, PhD</last_name>
    <phone>409-457-7894</phone>
    <email>DocWillis@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tina West RN, RN</last_name>
    <phone>888-621-5557</phone>
    <email>TinaWestRN@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Galveston Clinical Research Foundation</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77551</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr FB Willis, MBBS, PhD</last_name>
      <phone>409-457-7894</phone>
      <email>DocWillis@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Tina West, RN</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20647174</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23216231</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21906302</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29084405</PMID>
  </reference>
  <reference>
    <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. doi: 10.1111/j.1600-0838.1996.tb00469.x.</citation>
    <PMID>8960647</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26489022</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27537411</PMID>
  </reference>
  <reference>
    <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. doi: 10.1001/jama.289.3.323.</citation>
    <PMID>12525233</PMID>
  </reference>
  <reference>
    <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. doi: 10.1111/j.1753-4887.2006.tb00235.x.</citation>
    <PMID>16532900</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22648463</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27139723</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16534088</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19826285</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24257725</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25282294</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29190113</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28899747</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>May 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food Hypersensitivity</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03821818/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821818
org study id: 2018.04
nct id: NCT03821818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Change in Body Weight
time frame: 90-days
description: measure Kg
measure: Change in Body Fat %
time frame: 90-days
description: Percentage of fat vs lean mass
measure: Change in Body Mass Index (BMI)
time frame: 90-days
description: BMI calculation
arm group label: Control
description: Food Allergen Elimination only
arm group label: Allergen Elimination + Willis Exercise
description: Subjects will have food allergens eliminated and also perform Aerobic-surge, brief high intensity exercise > 75% max HR), five times/day.
intervention type: Behavioral
intervention name: Food Allergy Elimination + Willis Exercise
description: Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)
arm group label: Allergen Elimination + Willis Exercise
other name: Willis exercise
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank B Willis, MBBS, PhD
role: Principal Investigator
affiliation: Galveston Clinical Research Foundation
last name: Frank B Willis, MBBS, PhD
phone: 409-457-7894
email: DocWillis@yahoo.com
last name: Tina West RN, RN
phone: 888-621-5557
email: TinaWestRN@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: 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.
PMID: 20647174
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.
PMID: 23216231
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.
PMID: 21906302
citation: 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.
PMID: 29084405
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. doi: 10.1111/j.1600-0838.1996.tb00469.x.
PMID: 8960647
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.
PMID: 26489022
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.
PMID: 27537411
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. doi: 10.1001/jama.289.3.323.
PMID: 12525233
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. doi: 10.1111/j.1753-4887.2006.tb00235.x.
PMID: 16532900
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.
PMID: 22648463
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.
PMID: 27139723
citation: 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.
PMID: 16534088
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.
PMID: 19826285
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.
PMID: 24257725
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.
PMID: 25282294
citation: 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.
PMID: 29190113
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.
PMID: 28899747
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No
provided document: 