Investigation of the Perception of Protein Fortified Foods and Beverages
11. februar 2020 oppdatert av: Lisa Methven, University of Reading
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
- 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.
- 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.
Studietype
Intervensjonell
Registrering (Faktiske)
84
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Berkshire
-
Reading, Berkshire, Storbritannia, R66 6UR
- Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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")
|
|
Eksperimentell: Liquid Model
Whey Protein Beverages
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion)
Tidsramme: Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
|
Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion)
|
Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mouthdrying from cake
Tidsramme: At one time point (visit 3) reported at 1 year.
|
Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
|
At one time point (visit 3) reported at 1 year.
|
|
Mouthdrying from biscuits
Tidsramme: At one time point (visit 2) reported at 1 year.
|
Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
|
At one time point (visit 2) reported at 1 year.
|
|
Mouthdrying from whey protein
Tidsramme: At one time point (visit 1) reported at 1 year.
|
Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
|
At one time point (visit 1) reported at 1 year.
|
|
Saliva Collection
Tidsramme: Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)
|
Salivary flow rates from unstimulated and stimulated saliva samples.
|
Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.)
|
|
Questionnaire
Tidsramme: At one time point (visit 1) reported at 1 year.
|
Dental status and mouth behaviour categorisation via a questionnaire.
Category data (ie participants check boxes that apply).
The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status.
The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods.
|
At one time point (visit 1) reported at 1 year.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. januar 2019
Primær fullføring (Faktiske)
10. juli 2019
Studiet fullført (Faktiske)
10. juli 2019
Datoer for studieregistrering
Først innsendt
18. desember 2018
Først innsendt som oppfylte QC-kriteriene
8. januar 2019
Først lagt ut (Faktiske)
10. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UREC 18/46
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .