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Investigation of the Perception of Protein Fortified Foods and Beverages

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03798730
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Reading
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lisa Methven
Principal Investigator Affiliation University of Reading
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Individual Difference, Food Sensitivity, Food Preferences
Additional Details

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.

Arms & Interventions

Arms

Experimental: Solid Model

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

Experimental: Liquid Model

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

Interventions

Behavioral: - 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")

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.

Contact a Trial Team

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International Sites

Reading, Berkshire, United Kingdom

Status

Recruiting

Address

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

Reading, Berkshire, R66 6UR

Site Contact

Lisa Methven

l.methven@reading.ac.uk

+44(0) 118 378 8714

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