- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01042418
Appetite Profile After Intake of Rye Breakfast Meal
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The aim of the present study was to investigate if rye grain structure influence perceived appetite. A comparison of whole rye kernels and milled rye kernels were done in two study parts. In the first part the rye was served as porridge breakfasts and in the second one milled and whole kernels were included into bread breakfasts. In order to observe potential effects that would arise when the remains of the meal reaches the colon, the period of measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.
A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals on subjective appetite during 8 h after consumption.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 20 and 60 years;
- body mass index (BMI) 18-27 kg/m2;
- habit of consuming breakfast, lunch and dinner every day
- willingness to comply with the study procedures
Exclusion Criteria:
- intake of medicine likely to affect appetite or food intake;
- any medical condition involving the gastrointestinal tract;
- eating disorder;
- smoking;
- consumption of more than three cups of coffee per day;
- change of body weight more than 10% three months prior to screening;
- consumption of any restricted diet such as vegan, gluten free, slimming etc.;
- pregnancy, lactation or wish to become pregnant during the study period
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Whole kernel breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
|
Placebo komparator: Wheat reference breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
|
Aktiv komparator: Milled kernel breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Subjective appetite (hunger, satiety, desire to eat)
Tidsramme: 8 hours
|
8 hours
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RPM537
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