Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
keskiviikko 29. kesäkuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
17
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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-
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Lund, Ruotsi
- Aventure AB
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
35 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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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Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Placebo Comparator: Reference
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This intervention is based on white rice.
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Active Comparator: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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Active Comparator: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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Active Comparator: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Postprandial capillary blood glucose iAUC (0-120 min)
Aikaikkuna: 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 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Postprandial capillary blood glucose Cmax
Aikaikkuna: 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.
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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
Aikaikkuna: 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.
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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
Aikaikkuna: 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.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
|
Postprandial capillary blood glucose iAUC (0-60 min)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Fasting GLP-1
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
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Fasting PYY
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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