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Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals

28. juni 2021 opdateret af: Aventure AB
In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Lund, Sverige
        • Aventure AB

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or Female, 35 to 65 years of age
  2. BMI 22-29 (±0.5) kg/m2
  3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
  4. Healthy as determined by medical history and information provided by the volunteer.
  5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
  6. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

  1. Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1 or 2)
  2. Women who are pregnant or breast feeding
  3. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
  4. 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.
  5. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
  6. Use of antibiotics within 2 weeks of enrollment
  7. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  8. Allergy to ingredients included in investigational product, placebo, or standardized meal
  9. Participants restricted to a vegetarian or vegan diet
  10. Intolerance to gluten
  11. Individuals who are averse to capillary blood sampling
  12. Currently active smokers (or using other tobacco products, and e-cigarettes)
  13. Unstable medical conditions as determined by QI
  14. Participation in other clinical research trials
  15. Individuals who are cognitively impaired and/or who are unable to give informed consent
  16. Acute infection
  17. 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Reference
This intervention is a rice-based breakfast product.
Aktiv komparator: Whole grain breakfast product
This intervention is a whole grain-based breakfast product containing oats and barley.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The difference in capillary blood glucose between whole grain product and reference in the total incremental area under the curve iAUC(0-120 min) for all three meals (Breakfast iAUC0-120 min + Lunch iAUC0-120 min.+ Dinner iAUC0-120 min).
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))

Sekundære resultatmål

Resultatmål
Tidsramme
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the breakfast meal.
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the lunch meal.
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in the 1 and 2-hour incremental area under the curve (iAUC0-60 min and iAUC0-120 min) after the dinner meal.
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast, lunch and dinner meals respectively.
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast, lunch and dinner meals respectively.
Tidsramme: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Kristina Andersson, PhD, Aventure AB

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2021

Primær færdiggørelse (Faktiske)

15. juni 2021

Studieafslutning (Faktiske)

15. juni 2021

Datoer for studieregistrering

Først indsendt

4. maj 2021

Først indsendt, der opfyldte QC-kriterier

10. maj 2021

Først opslået (Faktiske)

17. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TSP2101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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