Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages

March 11, 2021 updated by: Lisa Methven, University of Reading
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Reading, United Kingdom, RG66UR
        • Sensory Science Centre, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solid Model
Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake
Behavioral: Solid Model
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.
Experimental: Liquid Model
Whey Protein Beverage
Behavioral: Liquid Model
To study the perception of whey protein beverages using repeated consumption sensory methods (e.g. rating mouthdrying over repeated sips of the drink).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucoadhesion
Time Frame: Change in protein left in mouth over from baseline to after consumption (45s)
Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion)
Change in protein left in mouth over from baseline to after consumption (45s)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouthdrying from cupcakes
Time Frame: Change in perceived mouthdruing from baseline over consumption (5 minutes)
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)
Change in perceived mouthdruing from baseline over consumption (5 minutes)
Mouthdrying from whey protein beverages
Time Frame: Change in perceived mouthdruing from baseline over consumption (20 minutes)
Perceived mouth drying from whey protein beverage using data from repeated consumption sensory methods (rating drying on line scales)
Change in perceived mouthdruing from baseline over consumption (20 minutes)
Saliva Collection
Time Frame: Days 1 and 2
Salivary flow rates from unstimulated and stimulated saliva samples
Days 1 and 2
Questionnaire
Time Frame: Day 1
Dental status, mouth behaviour, attitudes and portion size data via a questionnaire
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

March 19, 2020

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC 19/67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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