- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04302779
Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
To investigate whether whey protein beverages cause mouthdrying in older adults and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow.
To investigate whether protein fortification of cupcakes causes mouthdrying and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow in a home environment.
To investigate whether mucoadhesion is present within different food models, if sensitivity to mucoadhesion increases with age and to determine if a reduced salivary flow results in strengthened mucoadhesion.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Reading, Storbritannien, RG66UR
- Sensory Science Centre, University of Reading
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age (18-30 years or over 65 years)
- Healthy
Exclusion Criteria:
- Cognitively impaired
- Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance)
- Suffer from diabetes
- Oral surgery
- Stroke
- Smoker
- Cancer
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Solid Model
Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake
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Cupcakes will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating drying and discrimination tests 'which is the stronger in drying').
Measuring mucoadhesion via protein content remaining in saliva samples following consumption of cupcakes.
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Experimentell: Liquid Model
Whey Protein Beverage
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To study the perception of whey protein beverages using repeated consumption sensory methods (e.g.
rating mouthdrying over repeated sips of the drink).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mucoadhesion
Tidsram: Change in protein left in mouth over from baseline to after consumption (45s)
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Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion)
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Change in protein left in mouth over from baseline to after consumption (45s)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mouthdrying from cupcakes
Tidsram: Change in perceived mouthdruing from baseline over consumption (5 minutes)
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Perceived mouth drying from protein fortified lemon cupcake and whey permeate lemon cupcake using data from repeated consumption sensory methods (rating drying on line scales)
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Change in perceived mouthdruing from baseline over consumption (5 minutes)
|
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Mouthdrying from whey protein beverages
Tidsram: Change in perceived mouthdruing from baseline over consumption (20 minutes)
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Perceived mouth drying from whey protein beverage using data from repeated consumption sensory methods (rating drying on line scales)
|
Change in perceived mouthdruing from baseline over consumption (20 minutes)
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|
Saliva Collection
Tidsram: Days 1 and 2
|
Salivary flow rates from unstimulated and stimulated saliva samples
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Days 1 and 2
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Questionnaire
Tidsram: Day 1
|
Dental status, mouth behaviour, attitudes and portion size data via a questionnaire
|
Day 1
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UREC 19/67
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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