- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01965210
The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
21 oktober 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Uppsala, Sverige, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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|
Experimentell: 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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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Subjective appetite profiles
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Breath hydrogen and methane response
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2013
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
16 september 2013
Först inskickad som uppfyllde QC-kriterierna
15 oktober 2013
Första postat (Uppskatta)
18 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 oktober 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 oktober 2013
Senast verifierad
1 oktober 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SLU-IL-S1
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