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Completed

NCT Number: NCT04302779

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

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.

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Key information

Conditions

Individual Difference Behavior Feeding Behavior Food Intolerance Food Preferences Food Sensitivity Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sensory Science Centre, University of Reading

Reading, RG66UR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solid Model

Behavioral

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.

Liquid Model

Behavioral

To study the perception of whey protein beverages using repeated consumption sensory methods (e.g. rating mouthdrying over repeated sips of the drink).

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Saliva Collection

    Time frame: Days 1 and 2

    Salivary flow rates from unstimulated and stimulated saliva samples

  4. Questionnaire

    Time frame: Day 1

    Dental status, mouth behaviour, attitudes and portion size data via a questionnaire

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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