<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/NCT04507399</url>
  </required_header>
  <id_info>
    <org_study_id>SCFP 32/20</org_study_id>
    <nct_id>NCT04507399</nct_id>
  </id_info>
  <brief_title>Investigating Consumers Perception and Acceptance of Whey Beverages</brief_title>
  <official_title>Investigating Consumers Perception and Acceptance of Whey Beverages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Reading</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>
      Brief Summary: This study aims to investigate whether protein fortification of beverages&#xD;
      causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate whether whey protein beverages causes mouthdrying and reduces acceptability&#xD;
      compared with a control beverage (whey permeate beverage) and to determine whether&#xD;
      manipulating salivary flow rates influences mouthdrying.&#xD;
&#xD;
      To determine whether mucoadhesion is a probable cause of mouthdrying.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</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>
    <intervention_model_description>This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mucoadhesion and Mouthdrying</measure>
    <time_frame>Saliva collection and mouthdrying scoring throughout visits, 2 days</time_frame>
    <description>Following swallowing of different whey beverage samples (whey protein / whey permeate), volunteers will be asked either to rate samples for mouthdrying or to spit their saliva into a tube at specific timepoints (15s &amp; 60s) with appropriate rest periods. The rating and spitting times will be set within a balanced order protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mouthdrying from whey beverages</measure>
    <time_frame>1 day (Sampled at study visit one)</time_frame>
    <description>Perceived mouth drying from whey beverages (whey permeate / whey protein) using data from sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;). Scale for scoring is the gLMS scale (general linear magnitude scale); higher value is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manipulating saliva flow and mouthdrying from whey beverages</measure>
    <time_frame>1 day (Sampled at study visit one)</time_frame>
    <description>Volunteers will be asked to manipulate their saliva flow and consume whey beverages (whey permeate / whey protein) and score perceived mouth drying (data will be collected from sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva collection</measure>
    <time_frame>1 day (Sampled at study visit two)</time_frame>
    <description>Salivary flow rates from unstimulated and stimulated saliva samples.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Individual Difference</condition>
  <condition>Food Sensitivity</condition>
  <condition>Food Preferences</condition>
  <arm_group>
    <arm_group_label>Protein Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whey Protein Beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whey Permeate Beverage</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Liquid Model</intervention_name>
    <description>To study the perception of whey beverages using sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;)&#xD;
Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein and whey permeate beverages.</description>
    <arm_group_label>Control Beverage</arm_group_label>
    <arm_group_label>Protein Beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  No food allergies or intolerances&#xD;
&#xD;
          -  Non smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking prescribed medication that could influence study outcomes (such as saliva flow)&#xD;
&#xD;
          -  Relevant food allergies or intolerances&#xD;
&#xD;
          -  Outside age criteria&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Had oral surgery or a stroke&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Anyone who currently has COVID-19 symptoms or who has had COVID-19 within the last 4&#xD;
             weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Methven</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Reading</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom</name>
      <address>
        <city>Reading</city>
        <zip>RG66UR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008.</citation>
    <PMID>28260840</PMID>
  </reference>
  <reference>
    <citation>Withers CA, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e.</citation>
    <PMID>24092277</PMID>
  </reference>
  <reference>
    <citation>Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12.</citation>
    <PMID>26456531</PMID>
  </reference>
  <reference>
    <citation>Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17.</citation>
    <PMID>24440265</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Reading</investigator_affiliation>
    <investigator_full_name>Lisa Methven</investigator_full_name>
    <investigator_title>Head of Sensory Science</investigator_title>
  </responsible_party>
  <keyword>Mouthdrying</keyword>
  <keyword>Saliva Flow</keyword>
  <keyword>Mucoadhesion</keyword>
  <keyword>Oral Nutritional Supplements</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.</ipd_description>
  </patient_data>
  <!-- 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/NCT04507399
org study id: SCFP 32/20
nct id: NCT04507399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Brief Summary: This study aims to investigate whether protein fortification of beverages
      causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.
To investigate whether whey protein beverages causes mouthdrying and reduces acceptability
      compared with a control beverage (whey permeate beverage) and to determine whether
      manipulating salivary flow rates influences mouthdrying.

      To determine whether mucoadhesion is a probable cause of mouthdrying.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.
primary purpose: Other
masking: Single (Participant)
measure: Mucoadhesion and Mouthdrying
time frame: Saliva collection and mouthdrying scoring throughout visits, 2 days
description: Following swallowing of different whey beverage samples (whey protein / whey permeate), volunteers will be asked either to rate samples for mouthdrying or to spit their saliva into a tube at specific timepoints (15s & 60s) with appropriate rest periods. The rating and spitting times will be set within a balanced order protocol.
measure: Mouthdrying from whey beverages
time frame: 1 day (Sampled at study visit one)
description: Perceived mouth drying from whey beverages (whey permeate / whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying"). Scale for scoring is the gLMS scale (general linear magnitude scale); higher value is worse outcome.
measure: Manipulating saliva flow and mouthdrying from whey beverages
time frame: 1 day (Sampled at study visit one)
description: Volunteers will be asked to manipulate their saliva flow and consume whey beverages (whey permeate / whey protein) and score perceived mouth drying (data will be collected from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
measure: Saliva collection
time frame: 1 day (Sampled at study visit two)
description: Salivary flow rates from unstimulated and stimulated saliva samples.
arm group label: Protein Beverage
arm group type: Experimental
description: Whey Protein Beverage
arm group label: Control Beverage
arm group type: Experimental
description: Whey Permeate Beverage
intervention type: Behavioral
intervention name: Liquid Model
description: To study the perception of whey beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein and whey permeate beverages.
arm group label: Control Beverage
arm group label: Protein Beverage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Methven
role: Principal Investigator
affiliation: University of Reading
facility: 
country: United Kingdom
citation: Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008.
PMID: 28260840
citation: Withers CA, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e.
PMID: 24092277
citation: Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12.
PMID: 26456531
citation: Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17.
PMID: 24440265
responsible party type: Principal Investigator
investigator affiliation: University of Reading
investigator full name: Lisa Methven
investigator title: Head of Sensory Science
mesh term: Hypersensitivity
sharing ipd: No
ipd description: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.