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Completed

NCT Number: NCT03798730

Investigation of the Perception of Protein Fortified Foods and Beverages

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, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, R66 6UR, United Kingdom

About this study

  • 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.

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
  • 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

Treatment and study plan

Solid Model

Behavioral

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")

Liquid Model

Behavioral

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 outcomes

  1. 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.

    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 outcomes

  1. Mouthdrying from cake

    Time frame: At one time point (visit 3) reported at 1 year.

    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")

  2. Mouthdrying from biscuits

    Time frame: At one time point (visit 2) reported at 1 year.

    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")

  3. Mouthdrying from whey protein

    Time frame: At one time point (visit 1) reported at 1 year.

    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")

  4. 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.)

    Salivary flow rates from unstimulated and stimulated saliva samples.

  5. Questionnaire

    Time frame: At one time point (visit 1) reported at 1 year.

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Feb 12, 2020

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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