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

NCT04302779 | Completed

• 1 other identifier: UREC 19/67
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Individual Difference; Food Sensitivity; Food Preferences

Keywords

Older adults; Oral Nutritional Supplements; Saliva Flow; Mucoadhesion; Mouthdrying

Outcome Measures

Primary Outcomes (1)

• Mucoadhesion

  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 Outcomes (4)

• Mouthdrying from cupcakes

  Change in perceived mouthdruing from baseline over consumption (5 minutes)

• Mouthdrying from whey protein beverages

  Change in perceived mouthdruing from baseline over consumption (20 minutes)

• Saliva Collection

  Days 1 and 2

• Questionnaire

  Day 1

Study Arms (2)

Solid Model

EXPERIMENTAL

Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake

Behavioral: Solid Model

Liquid Model

EXPERIMENTAL

Whey Protein Beverage

Behavioral: Liquid Model

Interventions

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.

Solid Model

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).

Liquid Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age (18-30 years or over 65 years)
• Healthy

You may not qualify if:

• Cognitively impaired
• Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance)
• Suffer from diabetes
• Oral surgery
• Stroke
• Smoker
• Cancer

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Sensory Science Centre, University of Reading

Reading, RG66UR, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 28260840 BACKGROUND

• 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.

  PMID: 24092277 BACKGROUND

• 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.

  PMID: 26456531 BACKGROUND

• 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.

  PMID: 12859786 BACKGROUND

• 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.

  PMID: 20861088 BACKGROUND

• 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.

  PMID: 24440265 BACKGROUND

MeSH Terms

Conditions

Food Intolerance; Food Preferences

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Lisa Methven

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All samples provided to the participant are labelled with 3 digit random codes
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: March 10, 2020
• Study Start: February 13, 2020
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)