Modifying Whey Protein Fortified Drinks and Foods

• Sponsor: University of Reading (Other)
• Overall Status: Completed
• CT.gov ID: NCT04869722
• Collaborator: Volac International Limited (Other)
• Enrollment: 116
• Location: 1
• Arms: 2
• Actual Duration (Days): 24
• Patients Per Site Per Month: 147.1

Study Details

Study Description

Brief Summary

This study aims to investigate whether consumers differ in mouthdrying sensitivity and if mouthdrying can be modulated.

Condition or Disease	Intervention/Treatment	Phase
Individual Difference; Food Sensitivity; Food Preferences	Behavioral: Liquid Model; Behavioral: Solid Model	N/A

Detailed Description

1. To investigate whether older adults are more sensitive to whey protein derived mouthdrying compared with younger adults

2. To investigate whether increasing fat levels in a solid whey protein model influences mouthdrying perception

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This study involves both a crossover design where each participant tastes different protein fortified products with an appropriate break between the tasting. It is also both a within and between groups design as the responses from the older volunteers will be compared with the younger volunteers. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 1 study visits and all products will be presented with random blinding codes.This study involves both a crossover design where each participant tastes different protein fortified products with an appropriate break between the tasting. It is also both a within and between groups design as the responses from the older volunteers will be compared with the younger volunteers. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 1 study visits and all products will be presented with random blinding codes.
• Masking: Single (Participant)
• Masking Description: All samples provided to the participant are labelled with 3 digit random codes
• Primary Purpose: Other
• Official Title: Modifying Whey Protein Fortified Drinks and Foods to Improve Perception, Whilst Accounting for Individual Differences in Age (At Home Study)
• Actual Study Start Date: Apr 21, 2021
• Actual Primary Completion Date: May 15, 2021
• Actual Study Completion Date: May 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liquid Model Whey protein beverages varying in protein levels	Behavioral: Liquid Model; Whey protein beverages will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.
Experimental: Solid Model Protein fortified scones varying in fat levels	Behavioral: Solid Model; Protein fortified scones will be used, with the amount of fat varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.

Outcome Measures

Primary Outcome Measures

1. Whey Protein Beverages Mouthdrying Just Noticeable Difference Threshold [1 hour (sampled at visit one)]

   Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (discrimination tests asking "which sample is more mouthdrying" in each pair)

Secondary Outcome Measures

1. Whey Protein Beverages Mouthdrying Ratings [1 hour (sampled at visit one)]

   Perceived mouthdrying from whey protein beverages varying in protein levels using data from sensory methods (rating mouthdrying)

2. Modulating mouthdrying [1 hour (sampled at visit one)]

   Perceived mouthdrying from protein fortified scones varying in fat levels using data from sensory methods (rating mouthdrying as well as discrimination tests "which sample is more mouthdrying")

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age (18-30 years or over 65 years)

• Healthy

Exclusion Criteria:

• Relevant food allergies or intolerance

• Outside age criteria

• Diabetic

• Had oral surgery

• Had a stroke

• Smoker

• Cancer Taking prescribed medication that could influence study outcomes Anyone who currently has COVID-19 symptoms or who has had COVID-19 within the last 4 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom	Reading		United Kingdom	RG66UR

Sponsors and Collaborators

• University of Reading
• Volac International Limited

Investigators

• Principal Investigator: Lisa Methven, University of Reading

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Norton V, Lignou S, Bull SP, Gosney MA, Methven L. An Investigation of the Influence of Age and Saliva Flow on the Oral Retention of Whey Protein and Its Potential Effect on the Perception and Acceptance of Whey Protein Beverages. Nutrients. 2020 Aug 19;12(9). pii: E2506. doi: 10.3390/nu12092506.
• Norton V, Lignou S, Bull SP, Gosney MA, Methven L. Consistent Effects of Whey Protein Fortification on Consumer Perception and Liking of Solid Food Matrices (Cakes and Biscuits) Regardless of Age and Saliva Flow. Foods. 2020 Sep 21;9(9). pii: E1328. doi: 10.3390/foods9091328.
• 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.

• Responsible Party: Lisa Methven, Professor in Food and Sensory Science, University of Reading
• ClinicalTrials.gov Identifier: NCT04869722
• Other Study ID Numbers: UREC 20/35
• First Posted: May 3, 2021
• Last Update Posted: May 27, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lisa Methven, Professor in Food and Sensory Science, University of Reading: Older adults; Mouthdrying; Protein fortified foods and beverages
• Additional relevant MeSH terms: Hypersensitivity

Study Results

No Results Posted as of May 27, 2021