Clinical trial NCT03798730: Investigation of the Perception of Protein Fortified Foods and Beverages
Official title: Investigation of 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: 2019-01-10
Enrollment: 84
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 3 study visits and all foods will be presented with random blinding codes.
Primary purpose: OTHER

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: 1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
timeFrame: Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
Secondary outcomes:
measure: Mouthdrying from cake
timeFrame: At one time point (visit 3) reported at 1 year.
measure: Mouthdrying from biscuits
timeFrame: At one time point (visit 2) reported at 1 year.
measure: Mouthdrying from whey protein
timeFrame: At one time point (visit 1) reported at 1 year.
measure: Saliva Collection
timeFrame: 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.)
measure: Questionnaire
timeFrame: At one time point (visit 1) reported at 1 year.
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
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.