Clinical trial NCT04302779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Individual Difference
Food Sensitivity
Food Preferences
Keywords: Older adults
Oral Nutritional Supplements
Saliva Flow
Mucoadhesion
Mouthdrying
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mucoadhesion
timeFrame: Change in protein left in mouth over from baseline to after consumption (45s)
Secondary outcomes:
measure: Mouthdrying from cupcakes
timeFrame: Change in perceived mouthdruing from baseline over consumption (5 minutes)
measure: Mouthdrying from whey protein beverages
timeFrame: Change in perceived mouthdruing from baseline over consumption (20 minutes)
measure: Saliva Collection
timeFrame: Days 1 and 2
measure: Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Sensory Science Centre, University of Reading
Study officials:
affiliation: University of Reading
name: Lisa Methven
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.