- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04302779
Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Reading, Det Forenede Kongerige, RG66UR
- Sensory Science Centre, University of Reading
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Solid Model
Whey Permeate Lemon Cupcake and Protein Fortified Lemon Cupcake
|
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.
|
|
Eksperimentel: Liquid Model
Whey Protein Beverage
|
To study the perception of whey protein beverages using repeated consumption sensory methods (e.g.
rating mouthdrying over repeated sips of the drink).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mucoadhesion
Tidsramme: Change in protein left in mouth over from baseline to after consumption (45s)
|
Ex-vivo analysis using cupcakes (whey permeate and whey protein) (expectorated saliva collection to analyse protein for the extent of mucoadhesion)
|
Change in protein left in mouth over from baseline to after consumption (45s)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mouthdrying from cupcakes
Tidsramme: Change in perceived mouthdruing from baseline over consumption (5 minutes)
|
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)
|
Change in perceived mouthdruing from baseline over consumption (5 minutes)
|
|
Mouthdrying from whey protein beverages
Tidsramme: Change in perceived mouthdruing from baseline over consumption (20 minutes)
|
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)
|
|
Saliva Collection
Tidsramme: Days 1 and 2
|
Salivary flow rates from unstimulated and stimulated saliva samples
|
Days 1 and 2
|
|
Questionnaire
Tidsramme: Day 1
|
Dental status, mouth behaviour, attitudes and portion size data via a questionnaire
|
Day 1
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UREC 19/67
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Solid Model
-
University of ReadingVolac International LimitedAfsluttetIndividuel forskel | Madpræferencer | FødevarefølsomhedDet Forenede Kongerige
-
European Institute of OncologyRekruttering
-
University of StrathclydeUkendtSlag | HemiplegiDet Forenede Kongerige
-
Johnson & Johnson Surgical Vision, Inc.Afsluttet
-
National University, SingaporeUkendt
-
Johnson & Johnson Surgical Vision, Inc.Afsluttet
-
University of PittsburghPatient-Centered Outcomes Research InstituteAfsluttet
-
CORD, LLCAfsluttetGrå stærForenede Stater
-
Hospital Universitario La PazUniversity of MalagaRekrutteringTransplantationsrelateret lidelseSpanien
-
University of ParmaAfsluttetMotorisk aktivitet | Hemiplegisk cerebral pareseItalien