Investigation of the Perception of Protein Fortified Foods and Beverages

NCT ID: NCT03798730

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2019-07-10

Brief Summary

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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

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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.

Conditions

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Individual Difference Food Sensitivity Food Preferences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
All samples provided to the participant are labelled with 3 digit random codes

Study Groups

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Solid Model

1. Cake

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

Group Type EXPERIMENTAL

Solid Model

Intervention Type 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

Whey Protein Beverages

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

Group Type EXPERIMENTAL

Liquid Model

Intervention Type 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.

Interventions

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Solid Model

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")

Intervention Type BEHAVIORAL

Liquid Model

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Lisa Methven

Professor in Food and Sensory Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Methven

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28260840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24092277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26456531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12859786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20861088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24440265 (View on PubMed)

Other Identifiers

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UREC 18/46

Identifier Type: -

Identifier Source: org_study_id

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