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Modifying Whey Protein Fortified Drinks and Foods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869722
Recruitment Status : Completed
First Posted : May 3, 2021
Last Update Posted : May 27, 2021
Sponsor:
Collaborator:
Volac International Limited
Information provided by (Responsible Party):
Lisa Methven, University of Reading

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : April 21, 2021
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 15, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Whey Protein Beverages Mouthdrying Just Noticeable Difference Threshold [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869722


Locations
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United Kingdom
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
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Principal Investigator: Lisa Methven University of Reading
More Information
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Publications:

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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    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Methven, University of Reading:
Older adults
Mouthdrying
Protein fortified foods and beverages
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases