Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
29 juni 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
17
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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Lund, Sverige
- Aventure AB
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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
35 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Reference
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This intervention is based on white rice.
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Aktiv komparator: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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Aktiv komparator: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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Aktiv komparator: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postprandial capillary blood glucose iAUC (0-120 min)
Tidsram: 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.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postprandial capillary blood glucose Cmax
Tidsram: 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 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial capillary blood glucose Tmax
Tidsram: 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 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Fasting capillary blood glucose
Tidsram: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
|
Postprandial capillary blood glucose iAUC (0-60 min)
Tidsram: 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 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 capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Tidsram: 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.
|
|
Postprandial Insulin iAUC(0-120 min)
Tidsram: 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 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.
|
|
Postprandial Insulin Cmax
Tidsram: 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 Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial Insulin Tmax
Tidsram: 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 Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Fasting Insulin
Tidsram: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial insulin iAUC (0-60 min)
Tidsram: 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)
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fasting GLP-1
Tidsram: 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.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
|
GLP-1 iAUC(0-120 min)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Fasting PYY
Tidsram: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting PYY the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
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PYY 2-hour mean concentration
Tidsram: 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
Tidsram: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Samarbetspartners och utredare
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Sponsor
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 (Faktisk)
17 mars 2022
Primärt slutförande (Faktisk)
13 juni 2022
Avslutad studie (Faktisk)
13 juni 2022
Studieregistreringsdatum
Först inskickad
14 mars 2022
Först inskickad som uppfyllde QC-kriterierna
14 mars 2022
Första postat (Faktisk)
23 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- TSP2201
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
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