<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/NCT03241238</url>
  </required_header>
  <id_info>
    <org_study_id>UTK IRB-17-03817-XP</org_study_id>
    <nct_id>NCT03241238</nct_id>
  </id_info>
  <brief_title>The Effect of Dietary Fiber on Food Liking</brief_title>
  <official_title>The Effect of Dietary Fiber on Food Liking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</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>
      This study will investigate the effects of different fermenting fibers on liking of foods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to one of three orders to reduce the possibility of an order&#xD;
      effect.The participants will be given a brownie specific for the condition they are in and&#xD;
      then will be instructed to eat the brownie in 10 minutes. Twenty minutes after consuming the&#xD;
      brownie participants will be served a lunch. Dependent variables will be food liking.&#xD;
&#xD;
      At the start of the session the participant will be asked to recall all foods and beverages&#xD;
      consumed 24 hours prior to the scheduled appointment. During this recall if a participant&#xD;
      reports consuming any foods or beverages besides water within 3 hours of the appointment, the&#xD;
      appointment will be rescheduled. Participants will also be asked if they have participated in&#xD;
      any physical activity 24 hours prior to their scheduled appointment. If the participant&#xD;
      answers &quot;yes,&quot; then the appointment will be rescheduled.&#xD;
&#xD;
      After completing hunger and fullness VAS, participants will be presented with a preload of&#xD;
      brownie, β-glucan brownie, or psyllium brownie. The brownie will be prepared from the same&#xD;
      base recipe, thus be of the same approximate energy and macronutrient composition, but differ&#xD;
      in amount and type of dietary fiber. The base recipe will use a box of Pillsbury™ dark&#xD;
      chocolate brownie mix, two eggs, ¼ cup water and 2/3 cup of Food Club™ unsweetened&#xD;
      applesauce. The regular brownie will not contain any fiber, while the β-glucan and psyllium&#xD;
      brownie will contain about 6 grams of their respective fiber: Bulk Supplements™ β-glucan and&#xD;
      Frontier™ Psyllium Husk Powder. An additional tablespoon of water will be added to the&#xD;
      β-glucan brownie mix. The brownie will be presented warm, with two tablespoons of Cool Whip™&#xD;
      fat free spread on top, with 6 ounces of water. The participants will be told to consume all&#xD;
      of the brownie and toping, and to drink all of the 6 oz of water within 10 minutes. Next,&#xD;
      participants will rate their hunger and fullness again with the VAS and sit quietly for 20&#xD;
      minutes reading current magazines (i.e., People, Entertainment Weekly). After 20 minutes, the&#xD;
      participants will be presented with a sandwich (turkey or ham), chips, and grapes.The&#xD;
      sandwich will be cut into quarters on a plate, the chips and grapes will be presented in two&#xD;
      separate bowls. Following the presentation of the meal, participants will be instructed that&#xD;
      they will have 20 minutes to eat as much or as little as they would like of the meal provided&#xD;
      until satisfied, however they need to at least taste each of the foods. At the completion of&#xD;
      20 minutes, the lunch will be removed and the participant will be asked to complete a scale&#xD;
      for evaluating levels of hunger, fullness, and liking of the foods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No effect was found&#xD;
  </why_stopped>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hunger</measure>
    <time_frame>Change across the meal, 20 minutes</time_frame>
    <description>100 mm Visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fullness</measure>
    <time_frame>Change across the meal, 20 minutes</time_frame>
    <description>100 mm Visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liking</measure>
    <time_frame>Change across the meal, 20 minutes</time_frame>
    <description>100 mm Visual analog scale</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Different Fermentable Fiber</condition>
  <condition>Satiation</condition>
  <arm_group>
    <arm_group_label>Regular Brownie</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psyllium Brownie</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>β-glucan Brownie</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eating</intervention_name>
    <description>Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).</description>
    <arm_group_label>Psyllium Brownie</arm_group_label>
    <arm_group_label>Regular Brownie</arm_group_label>
    <arm_group_label>β-glucan Brownie</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 to 24.9 kg/m^2&#xD;
&#xD;
          -  Unrestrained eater (&lt;12 on Three Factor Eating Questionnaire [TFEQ])&#xD;
&#xD;
          -  report liking turkey or ham sandwiches, brownies, grapes, and potato chips (rate all&#xD;
             items &gt;50mm on a visual analogue scale [VAS]).&#xD;
&#xD;
          -  Report regularly eating before 10 am&#xD;
&#xD;
          -  Can completed all sessions within 6 weeks of the screening session.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report binge eating&#xD;
&#xD;
          -  Report a medical condition that influences eating&#xD;
&#xD;
          -  Report food allergies to the study foods&#xD;
&#xD;
          -  Currently smoke&#xD;
&#xD;
          -  Report dietary restrictions&#xD;
&#xD;
          -  Report not liking brownies&#xD;
&#xD;
          -  Report currently taking a medication that effects appetite&#xD;
&#xD;
          -  Report being pregnant or breast-feeding&#xD;
&#xD;
          -  Report being an athlete in training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Healthy Eating and Activity Laboratory, University of Tennessee</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Raynor HA, Epstein LH. Effects of sensory stimulation and post-ingestive consequences on satiation. Physiol Behav. 2000 Sep 15;70(5):465-70. doi: 10.1016/s0031-9384(00)00291-2.</citation>
    <PMID>11110999</PMID>
  </reference>
  <reference>
    <citation>Rebello CJ, O'Neil CE, Greenway FL. Dietary fiber and satiety: the effects of oats on satiety. Nutr Rev. 2016 Feb;74(2):131-47. doi: 10.1093/nutrit/nuv063. Epub 2016 Jan 2.</citation>
    <PMID>26724486</PMID>
  </reference>
  <reference>
    <citation>Brum JM, Gibb RD, Peters JC, Mattes RD. Satiety effects of psyllium in healthy volunteers. Appetite. 2016 Oct 1;105:27-36. doi: 10.1016/j.appet.2016.04.041. Epub 2016 May 7.</citation>
    <PMID>27166077</PMID>
  </reference>
  <reference>
    <citation>Delargy HJ, O'Sullivan KR, Fletcher RJ, Blundell JE. Effects of amount and type of dietary fibre (soluble and insoluble) on short-term control of appetite. Int J Food Sci Nutr. 1997 Jan;48(1):67-77. doi: 10.3109/09637489709006965.</citation>
    <PMID>9093551</PMID>
  </reference>
  <reference>
    <citation>McRorie JW Jr, McKeown NM. Understanding the Physics of Functional Fibers in the Gastrointestinal Tract: An Evidence-Based Approach to Resolving Enduring Misconceptions about Insoluble and Soluble Fiber. J Acad Nutr Diet. 2017 Feb;117(2):251-264. doi: 10.1016/j.jand.2016.09.021. Epub 2016 Nov 15.</citation>
    <PMID>27863994</PMID>
  </reference>
  <reference>
    <citation>Ridgway PS, Jeffrey DB. A comparison of the Three-Factor Eating Questionnaire and the Restraint Scale and consideration of Lowe's Three-Factor Model. Addict Behav. 1998 Jan-Feb;23(1):115-8. doi: 10.1016/s0306-4603(97)00031-2.</citation>
    <PMID>9468749</PMID>
  </reference>
  <reference>
    <citation>Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.</citation>
    <PMID>3981480</PMID>
  </reference>
  <reference>
    <citation>Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.</citation>
  </reference>
  <reference>
    <citation>Overweight and Obesity Statistics. (2012). Retrieved February 10, 2017, from https://www.niddk.nih.gov/health-information/health-statistics/Pages/overweight-obesity-statistics.aspx</citation>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 13, 2019</last_update_submitted>
  <last_update_submitted_qc>July 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Faculty Advisor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03241238
org study id: UTK IRB-17-03817-XP
nct id: NCT03241238
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effects of different fermenting fibers on liking of foods.
Participants will be randomized to one of three orders to reduce the possibility of an order
      effect.The participants will be given a brownie specific for the condition they are in and
      then will be instructed to eat the brownie in 10 minutes. Twenty minutes after consuming the
      brownie participants will be served a lunch. Dependent variables will be food liking.

      At the start of the session the participant will be asked to recall all foods and beverages
      consumed 24 hours prior to the scheduled appointment. During this recall if a participant
      reports consuming any foods or beverages besides water within 3 hours of the appointment, the
      appointment will be rescheduled. Participants will also be asked if they have participated in
      any physical activity 24 hours prior to their scheduled appointment. If the participant
      answers "yes," then the appointment will be rescheduled.

      After completing hunger and fullness VAS, participants will be presented with a preload of
      brownie, β-glucan brownie, or psyllium brownie. The brownie will be prepared from the same
      base recipe, thus be of the same approximate energy and macronutrient composition, but differ
      in amount and type of dietary fiber. The base recipe will use a box of Pillsbury™ dark
      chocolate brownie mix, two eggs, ¼ cup water and 2/3 cup of Food Club™ unsweetened
      applesauce. The regular brownie will not contain any fiber, while the β-glucan and psyllium
      brownie will contain about 6 grams of their respective fiber: Bulk Supplements™ β-glucan and
      Frontier™ Psyllium Husk Powder. An additional tablespoon of water will be added to the
      β-glucan brownie mix. The brownie will be presented warm, with two tablespoons of Cool Whip™
      fat free spread on top, with 6 ounces of water. The participants will be told to consume all
      of the brownie and toping, and to drink all of the 6 oz of water within 10 minutes. Next,
      participants will rate their hunger and fullness again with the VAS and sit quietly for 20
      minutes reading current magazines (i.e., People, Entertainment Weekly). After 20 minutes, the
      participants will be presented with a sandwich (turkey or ham), chips, and grapes.The
      sandwich will be cut into quarters on a plate, the chips and grapes will be presented in two
      separate bowls. Following the presentation of the meal, participants will be instructed that
      they will have 20 minutes to eat as much or as little as they would like of the meal provided
      until satisfied, however they need to at least taste each of the foods. At the completion of
      20 minutes, the lunch will be removed and the participant will be asked to complete a scale
      for evaluating levels of hunger, fullness, and liking of the foods.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Hunger
time frame: Change across the meal, 20 minutes
description: 100 mm Visual analog scale
measure: Fullness
time frame: Change across the meal, 20 minutes
description: 100 mm Visual analog scale
measure: Liking
time frame: Change across the meal, 20 minutes
description: 100 mm Visual analog scale
arm group label: Regular Brownie
arm group type: Other
description: Regular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later.
arm group label: Psyllium Brownie
arm group type: Other
description: For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later.
arm group label: β-glucan Brownie
arm group type: Other
description: For the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later
intervention type: Other
intervention name: Eating
description: Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
arm group label: Psyllium Brownie
arm group label: Regular Brownie
arm group label: β-glucan Brownie
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Raynor HA, Epstein LH. Effects of sensory stimulation and post-ingestive consequences on satiation. Physiol Behav. 2000 Sep 15;70(5):465-70. doi: 10.1016/s0031-9384(00)00291-2.
PMID: 11110999
citation: Rebello CJ, O'Neil CE, Greenway FL. Dietary fiber and satiety: the effects of oats on satiety. Nutr Rev. 2016 Feb;74(2):131-47. doi: 10.1093/nutrit/nuv063. Epub 2016 Jan 2.
PMID: 26724486
citation: Brum JM, Gibb RD, Peters JC, Mattes RD. Satiety effects of psyllium in healthy volunteers. Appetite. 2016 Oct 1;105:27-36. doi: 10.1016/j.appet.2016.04.041. Epub 2016 May 7.
PMID: 27166077
citation: Delargy HJ, O'Sullivan KR, Fletcher RJ, Blundell JE. Effects of amount and type of dietary fibre (soluble and insoluble) on short-term control of appetite. Int J Food Sci Nutr. 1997 Jan;48(1):67-77. doi: 10.3109/09637489709006965.
PMID: 9093551
citation: McRorie JW Jr, McKeown NM. Understanding the Physics of Functional Fibers in the Gastrointestinal Tract: An Evidence-Based Approach to Resolving Enduring Misconceptions about Insoluble and Soluble Fiber. J Acad Nutr Diet. 2017 Feb;117(2):251-264. doi: 10.1016/j.jand.2016.09.021. Epub 2016 Nov 15.
PMID: 27863994
citation: Ridgway PS, Jeffrey DB. A comparison of the Three-Factor Eating Questionnaire and the Restraint Scale and consideration of Lowe's Three-Factor Model. Addict Behav. 1998 Jan-Feb;23(1):115-8. doi: 10.1016/s0306-4603(97)00031-2.
PMID: 9468749
citation: Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
PMID: 3981480
citation: Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
citation: Overweight and Obesity Statistics. (2012). Retrieved February 10, 2017, from https://www.niddk.nih.gov/health-information/health-statistics/Pages/overweight-obesity-statistics.aspx
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Faculty Advisor