<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/NCT03798730</url>
  </required_header>
  <id_info>
    <org_study_id>UREC 18/46</org_study_id>
    <nct_id>NCT03798730</nct_id>
  </id_info>
  <brief_title>Investigation of the Perception of Protein Fortified Foods and Beverages</brief_title>
  <official_title>Investigation of the Perception of Protein Fortified Foods and 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>
      This study aims to investigate whether protein fortification of foods and beverages causes&#xD;
      mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To investigate, by using protein fortified foods and beverages, whether mucoadhesion to&#xD;
           the oral cavity is greater for older adults compared to younger adults and determine&#xD;
           whether it is related to salivary flow rate.&#xD;
&#xD;
        2. To determine whether protein fortification of foods and beverages causes mouthdrying and&#xD;
           whether perception and acceptance are influenced by age and individual differences in&#xD;
           saliva flow.&#xD;
&#xD;
      These aims will be investigated using two different models: a liquid model using whey protein&#xD;
      and a solid model using protein fortified biscuits and cakes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</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 (not fortified) and the protein fortified product with an appropriate break between the two sessions. It is also both a within and between groups design as the responses from the older participants will be compared to the younger participants. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all foods will be presented with random blinding codes.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All samples provided to the participant are labelled with 3 digit random codes</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)</measure>
    <time_frame>Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.</time_frame>
    <description>Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mouthdrying from cake</measure>
    <time_frame>At one time point (visit 3) reported at 1 year.</time_frame>
    <description>Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mouthdrying from biscuits</measure>
    <time_frame>At one time point (visit 2) reported at 1 year.</time_frame>
    <description>Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mouthdrying from whey protein</measure>
    <time_frame>At one time point (visit 1) reported at 1 year.</time_frame>
    <description>Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data 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>Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)</time_frame>
    <description>Salivary flow rates from unstimulated and stimulated saliva samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>At one time point (visit 1) reported at 1 year.</time_frame>
    <description>Dental status and mouth behaviour categorisation via a questionnaire. Category data (ie participants check boxes that apply). The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status. The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Individual Difference</condition>
  <condition>Food Sensitivity</condition>
  <condition>Food Preferences</condition>
  <arm_group>
    <arm_group_label>Solid Model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cake&#xD;
-Control Vanilla Cake and Protein Fortified Vanilla Cake&#xD;
Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liquid Model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whey Protein Beverages&#xD;
Native sample (protein unheated)&#xD;
Denatured whey protein (protein heated to denature)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Solid Model</intervention_name>
    <description>Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests &quot;which is the stronger in drying&quot;)</description>
    <arm_group_label>Solid Model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Liquid Model</intervention_name>
    <description>Intervention Description: To study the effect of protein denaturation on perception of whey protein beverages using sensory methods (rating drying as well as discrimination tests &quot;which is the stronger in drying&quot;). Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein beverages.</description>
    <arm_group_label>Liquid Model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-30 years or over 65 years&#xD;
&#xD;
          -  Self reported as healthy (no specific disease states)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitively impaired&#xD;
&#xD;
          -  Allergies or intolerances that include coeliac disease, lactose or gluten intolerance&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Had oral surgery&#xD;
&#xD;
          -  Had stroke&#xD;
&#xD;
          -  Smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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 Sciences, University of Reading</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>R66 6UR</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>Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. doi: 10.1046/j.1365-2648.2003.02710.x.</citation>
    <PMID>12859786</PMID>
  </reference>
  <reference>
    <citation>Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22.</citation>
    <PMID>20861088</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>February 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</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>Professor in Food and Sensory Science</investigator_title>
  </responsible_party>
  <keyword>Older Adults</keyword>
  <keyword>Oral Nutritional Supplements</keyword>
  <keyword>Saliva Flow</keyword>
  <keyword>Mucoadhesion</keyword>
  <keyword>Mouthdrying</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/NCT03798730
org study id: UREC 18/46
nct id: NCT03798730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate whether protein fortification of foods and beverages causes
      mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.
1. To investigate, by using protein fortified foods and beverages, whether mucoadhesion to
           the oral cavity is greater for older adults compared to younger adults and determine
           whether it is related to salivary flow rate.

        2. To determine whether protein fortification of foods and beverages causes mouthdrying and
           whether perception and acceptance are influenced by age and individual differences in
           saliva flow.

      These aims will be investigated using two different models: a liquid model using whey protein
      and a solid model using protein fortified biscuits and cakes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study involves both a crossover design where each participant tastes both the control product (not fortified) and the protein fortified product with an appropriate break between the two sessions. It is also both a within and between groups design as the responses from the older participants will be compared to the younger participants. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all foods will be presented with random blinding codes.
primary purpose: Other
masking: Single (Participant)
masking description: All samples provided to the participant are labelled with 3 digit random codes
measure: Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
time frame: Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
description: Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion)
measure: Mouthdrying from cake
time frame: At one time point (visit 3) reported at 1 year.
description: Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
measure: Mouthdrying from biscuits
time frame: At one time point (visit 2) reported at 1 year.
description: Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
measure: Mouthdrying from whey protein
time frame: At one time point (visit 1) reported at 1 year.
description: Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
measure: Saliva Collection
time frame: Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)
description: Salivary flow rates from unstimulated and stimulated saliva samples.
measure: Questionnaire
time frame: At one time point (visit 1) reported at 1 year.
description: Dental status and mouth behaviour categorisation via a questionnaire. Category data (ie participants check boxes that apply). The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status. The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods.
arm group label: Solid Model
arm group type: Experimental
description: Cake
-Control Vanilla Cake and Protein Fortified Vanilla Cake
Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit
arm group label: Liquid Model
arm group type: Experimental
description: Whey Protein Beverages
Native sample (protein unheated)
Denatured whey protein (protein heated to denature)
intervention type: Behavioral
intervention name: Solid Model
description: Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests "which is the stronger in drying")
arm group label: Solid Model
intervention type: Behavioral
intervention name: Liquid Model
description: Intervention Description: To study the effect of protein denaturation on perception of whey protein 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 beverages.
arm group label: Liquid Model
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. doi: 10.1046/j.1365-2648.2003.02710.x.
PMID: 12859786
citation: Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22.
PMID: 20861088
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: Professor in Food and 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.