The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
21. Oktober 2013 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
22
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Uppsala, Schweden, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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.
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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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Experimental: 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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Experimental: 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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Aktiver 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Subjective appetite profiles
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Breath hydrogen and methane response
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2013
Primärer Abschluss (Tatsächlich)
1. August 2013
Studienabschluss (Tatsächlich)
1. August 2013
Studienanmeldedaten
Zuerst eingereicht
16. September 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Oktober 2013
Zuerst gepostet (Schätzen)
18. Oktober 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
22. Oktober 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Oktober 2013
Zuletzt verifiziert
1. Oktober 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- SLU-IL-S1
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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