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Investigation of the Perception of Protein Fortified Foods and Beverages

Primary Purpose

Individual Difference, Food Sensitivity, Food Preferences

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Solid Model
Liquid Model
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Individual Difference focused on measuring Older Adults, Oral Nutritional Supplements, Saliva Flow, Mucoadhesion, Mouthdrying

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-30 years or over 65 years
  • Self reported as healthy (no specific disease states)

Exclusion Criteria:

  • Cognitively impaired
  • Allergies or intolerances that include coeliac disease, lactose or gluten intolerance
  • Diabetic
  • Had oral surgery
  • Had stroke
  • Smoker

Sites / Locations

  • Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Solid Model

Liquid Model

Arm Description

Cake -Control Vanilla Cake and Protein Fortified Vanilla Cake Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit

Whey Protein Beverages Native sample (protein unheated) Denatured whey protein (protein heated to denature)

Outcomes

Primary Outcome Measures

Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
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)

Secondary Outcome Measures

Mouthdrying from cake
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")
Mouthdrying from biscuits
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")
Mouthdrying from whey protein
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")
Saliva Collection
Salivary flow rates from unstimulated and stimulated saliva samples.
Questionnaire
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.

Full Information

First Posted
December 18, 2018
Last Updated
February 11, 2020
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT03798730
Brief Title
Investigation of the Perception of Protein Fortified Foods and Beverages
Official Title
Investigation of the Perception of Protein Fortified Foods and Beverages
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individual Difference, Food Sensitivity, Food Preferences
Keywords
Older Adults, Oral Nutritional Supplements, Saliva Flow, Mucoadhesion, Mouthdrying

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
All samples provided to the participant are labelled with 3 digit random codes
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solid Model
Arm Type
Experimental
Arm Description
Cake -Control Vanilla Cake and Protein Fortified Vanilla Cake Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit
Arm Title
Liquid Model
Arm Type
Experimental
Arm Description
Whey Protein Beverages Native sample (protein unheated) Denatured whey protein (protein heated to denature)
Intervention Type
Behavioral
Intervention Name(s)
Solid Model
Intervention 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")
Intervention Type
Behavioral
Intervention Name(s)
Liquid Model
Intervention 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.
Primary Outcome Measure Information:
Title
Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
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)
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.
Secondary Outcome Measure Information:
Title
Mouthdrying from cake
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")
Time Frame
At one time point (visit 3) reported at 1 year.
Title
Mouthdrying from biscuits
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")
Time Frame
At one time point (visit 2) reported at 1 year.
Title
Mouthdrying from whey protein
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")
Time Frame
At one time point (visit 1) reported at 1 year.
Title
Saliva Collection
Description
Salivary flow rates from unstimulated and stimulated saliva samples.
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.)
Title
Questionnaire
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.
Time Frame
At one time point (visit 1) reported at 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-30 years or over 65 years Self reported as healthy (no specific disease states) Exclusion Criteria: Cognitively impaired Allergies or intolerances that include coeliac disease, lactose or gluten intolerance Diabetic Had oral surgery Had stroke Smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Methven
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
R66 6UR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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.
Citations:
PubMed Identifier
28260840
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.
Results Reference
background
PubMed Identifier
24092277
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.
Results Reference
background
PubMed Identifier
26456531
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.
Results Reference
background
PubMed Identifier
12859786
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.
Results Reference
background
PubMed Identifier
20861088
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.
Results Reference
background
PubMed Identifier
24440265
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.
Results Reference
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Investigation of the Perception of Protein Fortified Foods and Beverages

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