The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
21. oktober 2013 opdateret af: Isabella Lee, Swedish University of Agricultural Sciences
The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products.
The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein.
The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design.
Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread.
Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast.
The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour.
Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels.
The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids.
Gastric emptying rate will also be evaluated using paracetamol as an indicator.
Hormonal responses, changes in the metabolome and fermentation products will be related to subjective appetite and to differences in composition of the breakfasts.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Uppsala, Sverige, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Women must be post-menopausal or habitually take hormonal contraceptives
- Habitual breakfast eaters
Exclusion Criteria:
- Non-contraceptive use among pre-menopausal women
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
- Hyperinsulinemic
- Thyroid disease
- Metabolic issues
- Diabetes
- Physical or psychological problems eating
- Food intolerances/allergies to foods included in the study
- Vegetarians
- Intolerance/allergy to paracetamol
- Heavy smokers
- Recent or concurrent participation in an intervention research study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Rye + high dose inulin + low dose gluten
Rye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Eksperimentel: Rye + equal doses of inulin & gluten
Rye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Eksperimentel: Rye + low dose inulin + high dose gluten
Rye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten.
|
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Eksperimentel: Large non-supplemented rye
Large portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Eksperimentel: Small non-supplemented rye
Small portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Aktiv komparator: Refined wheat bread
Refined wheat bread.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective appetite profiles
Tidsramme: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).
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8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Breath hydrogen and methane response
Tidsramme: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).
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8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Gastric emptying rate
Tidsramme: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Paracetamol (1 g) was taken with breakfast.
The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose and hormonal response
Tidsramme: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Metabolic profiles
Tidsramme: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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The flux of nutrients is measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre
Tidsramme: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Ad libitum food intake
Tidsramme: 8 h after breakfast (480 min)
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Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.
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8 h after breakfast (480 min)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2013
Primær færdiggørelse (Faktiske)
1. august 2013
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
16. september 2013
Først indsendt, der opfyldte QC-kriterier
15. oktober 2013
Først opslået (Skøn)
18. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. oktober 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SLU-IL-S1
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 .
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