Clinical trial NCT05291806: Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
Official title: Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose Response
Lead sponsor: Aventure AB
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 17
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male or Female, 35 to 65 years of age
2. BMI 18.5-29.9 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, 2, 3 or 4)
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, reference, or standardized meal
9. Participants restricted to a vegetarian or vegan diet
10. Intolerance to gluten
11. Individuals who are averse to venous catheterization or 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

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Primary outcomes:
measure: Postprandial capillary blood glucose iAUC (0-120 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Secondary outcomes:
measure: Postprandial capillary blood glucose Cmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial capillary blood glucose Tmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Fasting capillary blood glucose
timeFrame: Outcome measures will be assessed just before the standardized meal is consumed.
measure: Postprandial capillary blood glucose iAUC (0-60 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial Insulin iAUC(0-120 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial Insulin Cmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial Insulin Tmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Fasting Insulin
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial insulin iAUC (0-60 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Other outcomes:
measure: Fasting GLP-1
timeFrame: Outcome measures will be assessed just before the standardized meal is consumed.
measure: GLP-1 iAUC(0-120 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: GLP-1 iAUC(0-60 min)
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: GLP-1 Cmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: GLP-1 Tmax
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: Fasting PYY
timeFrame: Outcome measures will be assessed just before the standardized meal is consumed.
measure: PYY 2-hour mean concentration
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
measure: PYY 1-hour mean concentration
timeFrame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Locations:
city: Lund
country: Sweden
facility: Aventure AB
Study officials:
References: