Investigation of the Perception of Protein Fortified Foods and Beverages

NCT03798730 | Completed

• 1 other identifier: UREC 18/46
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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)

• Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)

  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)

  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 (5)

• Mouthdrying from cake

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

• Mouthdrying from biscuits

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

• Mouthdrying from whey protein

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

• Saliva Collection

  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.)

• Questionnaire

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

Study Arms (2)

Solid Model

EXPERIMENTAL

1. Cake -Control Vanilla Cake and Protein Fortified Vanilla Cake 2. Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit

Behavioral: Solid Model

Liquid Model

EXPERIMENTAL

Whey Protein Beverages * Native sample (protein unheated) * Denatured whey protein (protein heated to denature)

Behavioral: Liquid Model

Interventions

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")

Solid Model

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.

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
• Self reported as healthy (no specific disease states)

You may not qualify if:

• Cognitively impaired
• Allergies or intolerances that include coeliac disease, lactose or gluten intolerance
• Diabetic
• Had oral surgery
• Had stroke
• Smoker

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, R66 6UR, 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 in Food and Sensory Science

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 3 study visits and all foods will be presented with random blinding codes.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 10, 2019
• Study Start: January 7, 2019
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)