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Investigating the Influence of Age and Saliva Flow on 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)
  • Healthy

Exclusion Criteria:

  • Cognitively impaired
  • Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance)
  • Suffer from diabetes
  • Oral surgery
  • Stroke
  • Smoker
  • Cancer

Sites / Locations

  • Sensory Science Centre, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Solid Model

Liquid Model

Arm Description

Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake

Whey Protein Beverage

Outcomes

Primary Outcome Measures

Mucoadhesion
Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion)

Secondary Outcome Measures

Mouthdrying from cupcakes
Perceived mouth drying from protein fortified lemon cupcake and whey permeate lemon cupcake using data from repeated consumption sensory methods (rating drying on line scales)
Mouthdrying from whey protein beverages
Perceived mouth drying from whey protein beverage using data from repeated consumption sensory methods (rating drying on line scales)
Saliva Collection
Salivary flow rates from unstimulated and stimulated saliva samples
Questionnaire
Dental status, mouth behaviour, attitudes and portion size data via a questionnaire

Full Information

First Posted
February 11, 2020
Last Updated
March 11, 2021
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT04302779
Brief Title
Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages
Official Title
Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (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
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 whether whey protein beverages cause mouthdrying in older adults and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow. To investigate whether protein fortification of cupcakes causes mouthdrying and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow in a home environment. To investigate whether mucoadhesion is present within different food models, if sensitivity to mucoadhesion increases with age and to determine if a reduced salivary flow results in strengthened mucoadhesion.

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 2 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
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solid Model
Arm Type
Experimental
Arm Description
Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake
Arm Title
Liquid Model
Arm Type
Experimental
Arm Description
Whey Protein Beverage
Intervention Type
Behavioral
Intervention Name(s)
Solid Model
Intervention Description
Cupcakes will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating drying and discrimination tests 'which is the stronger in drying'). Measuring mucoadhesion via protein content remaining in saliva samples following consumption of cupcakes.
Intervention Type
Behavioral
Intervention Name(s)
Liquid Model
Intervention Description
To study the perception of whey protein beverages using repeated consumption sensory methods (e.g. rating mouthdrying over repeated sips of the drink).
Primary Outcome Measure Information:
Title
Mucoadhesion
Description
Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion)
Time Frame
Change in protein left in mouth over from baseline to after consumption (45s)
Secondary Outcome Measure Information:
Title
Mouthdrying from cupcakes
Description
Perceived mouth drying from protein fortified lemon cupcake and whey permeate lemon cupcake using data from repeated consumption sensory methods (rating drying on line scales)
Time Frame
Change in perceived mouthdruing from baseline over consumption (5 minutes)
Title
Mouthdrying from whey protein beverages
Description
Perceived mouth drying from whey protein beverage using data from repeated consumption sensory methods (rating drying on line scales)
Time Frame
Change in perceived mouthdruing from baseline over consumption (20 minutes)
Title
Saliva Collection
Description
Salivary flow rates from unstimulated and stimulated saliva samples
Time Frame
Days 1 and 2
Title
Questionnaire
Description
Dental status, mouth behaviour, attitudes and portion size data via a questionnaire
Time Frame
Day 1

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) Healthy Exclusion Criteria: Cognitively impaired Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance) Suffer from diabetes Oral surgery Stroke Smoker Cancer
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, University of Reading
City
Reading
ZIP/Postal Code
RG66UR
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
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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
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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
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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
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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
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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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Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages

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