Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
29 juni 2022 bijgewerkt door: Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
17
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Lund, Zweden
- Aventure AB
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
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Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Reference
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This intervention is based on white rice.
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Actieve vergelijker: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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Actieve vergelijker: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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Actieve vergelijker: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postprandial capillary blood glucose iAUC (0-120 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postprandial capillary blood glucose Cmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose Tmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting capillary blood glucose
Tijdsspanne: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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Postprandial capillary blood glucose iAUC (0-60 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin iAUC(0-120 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin Cmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial Insulin Tmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting Insulin
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial insulin iAUC (0-60 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fasting GLP-1
Tijdsspanne: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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GLP-1 iAUC(0-120 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 iAUC(0-60 min)
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Cmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Tmax
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting PYY
Tijdsspanne: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting PYY the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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PYY 2-hour mean concentration
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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PYY 1-hour mean concentration
Tijdsspanne: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
17 maart 2022
Primaire voltooiing (Werkelijk)
13 juni 2022
Studie voltooiing (Werkelijk)
13 juni 2022
Studieregistratiedata
Eerst ingediend
14 maart 2022
Eerst ingediend dat voldeed aan de QC-criteria
14 maart 2022
Eerst geplaatst (Werkelijk)
23 maart 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 juli 2022
Laatste update ingediend die voldeed aan QC-criteria
29 juni 2022
Laatst geverifieerd
1 maart 2022
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- TSP2201
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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