Cross-linked Emulsion Study
21. juni 2012 oppdatert av: Quadram Institute Bioscience
A Pilot Study on the Effect of Protein Cross-linking on Gastric Layering and Emptying of a Food Emulsion
This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of two food emulsions.
Two types of milk protein stabilised food emulsion will be compared, one standard emulsion preparation and one emulsion preparation cross-linked with microbial transglutaminase.
The information from this study will then be compared to data on satiety and endocrine hormones from a parallel study undertaken in Finland using the same two meal formulations.
The drinks will be labeled with a stable isotope of carbon and samples of breath collected every 20 minutes after consumption of the drink.
This will allow gastric residence time to be calculated.
The pilot will also fulfill two secondary objectives.
At the same time as the breath samples are collected MRI scans of the upper abdomen will be made so that gastric volumes can be measured in order to compare the two methods of measuring gastric emptying rates.
Additionally, samples of saliva will also be collected after every MRI scan for subsequent mass spectrometry analysis.
These are to assess the efficacy of mass spectrometry analysis for detection of the presence of specific digestion related hormones such as ghrelin.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
4
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Norfolk
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Norwich, Norfolk, Storbritannia, NR4 7UA
- IFR
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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
20 år til 50 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Male (hormonal status of women would introduce more variation within small group)
- Age 20-50 years
- BMI 19-30
- Apparently healthy
- Normally eat lunch
- Willing to eat the "milkshake" style emulsion
- Provides written informed consent
Exclusion Criteria:
- You have an allergy or intolerance to rape seed oil, milk or milk proteins including lactose
- Smokers or smoked within the last year (smoking affects satiety/hunger)
- Diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease
- Have had surgery on the stomach or intestine or suffered from gastrointestinal disease, whether diagnosed or self reported
- A history of TB or hepatitis.
- Regular (more than once in 10 days) use of antacids, laxatives
- Diagnosis with any mouth, dental, throat or digestive problem that may affect normal eating and digestion of food.
- Take prescription medication for digestive or gastrointestinal conditions.
- Volunteers taking part in another study (other than a questionnaire based study).
- Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
- Individuals with special dietary requirements (eg vegetarians)
- People with eating disorders (eg. anorexia, bulimia)
- If any of the clinical screening results are indicative of a health problem which would affect the volunteers well-being or which would affect the study data.
- Refusal to give permission to inform GP of participation in study
- Allergic to any of the constituents of the test meal
- Recent unexplained weight gain or loss
- History of back problems or any other condition which limit ability to repeatedly sit up and lie down
- Hiatus Hernia
MRI scanning specific exclusion criteria
- Cardiac pacemaker or artificial heart valve
- Any surgery in the last 6 months
- Aneurysm clips (metal clips from surgery)
- Implant, pump or any medical device in the body (eg cochlear implant, neurostimulator, intra-ventricular shunt)
- Worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings
- Have artificial eyes or limbs
- Have been injured with shrapnel or bullets
- Suffer from fits, blackouts or epilepsy
- Claustrophobia sufferer
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: transglutaminase cross-linking of emulsion
The impact of enzyme cross linking of the protein stabilising the test emulsion on gastric emptying rate will be assessed.
In this crossover study the subjects will also consume ( on a separate day)an emulsion of the same formulation but not cross-linked.
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This study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Rate of gastric emptying by MRI
Tidsramme: 20 minute intervals over 3 hours
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rate measured from MRI images of gastric contents
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20 minute intervals over 3 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Gastric emptying by C13
Tidsramme: every 20 minutes over 3 hours
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compare gastric emptying rates measured by MRI with those measured by 13C acetic acid breath tests.
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every 20 minutes over 3 hours
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mass spectrometry detection of GI tract hormones in saliva
Tidsramme: every 20 minutes over 3 hours
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every 20 minutes over 3 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alan R Mackie, PhD, Quadram Institute Bioscience
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
1. november 2010
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
8. april 2011
Først innsendt som oppfylte QC-kriteriene
8. april 2011
Først lagt ut (Anslag)
11. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. juni 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juni 2012
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IFR04/2010
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. .