Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

Not Applicable

Completed

• Conditions: Blood Glucose Response
• Interventions: Other: Reference Product; Other: Wholegrain product Dose A, cut kernels; Other: Wholegrain product Dose A; Other: Wholegrain product Dose B

• Registration Number: NCT05291806
• Lead Sponsor: Aventure AB

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study Start: 2022-03-17
• Study First Posted: 2022-03-23
• Primary Completion: 2022-06-13
• Study Completion: 2022-06-13
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	Reference Product	-
Cut cereal kernels Dose A	Wholegrain product Dose A, cut kernels	-
Whole cereal kernels Dose A	Wholegrain product Dose A	-
Whole cereal kernels Dose B	Wholegrain product Dose B	-

Primary Outcome Measures

Name	Time	Method
Postprandial capillary blood glucose iAUC (0-120 min)	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.

Secondary Outcome Measures

Name	Time	Method
Fasting capillary blood glucose	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.
Postprandial Insulin Cmax	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.
Postprandial Insulin Tmax	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.
Postprandial insulin iAUC (0-60 min)	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.
Postprandial capillary blood glucose Cmax	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.
Postprandial capillary blood glucose iAUC (0-60 min)	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.
Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)	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.
Postprandial Insulin iAUC(0-120 min)	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.
Fasting Insulin	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.
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)	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.
Postprandial capillary blood glucose Tmax	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.

Trial Locations

Locations (1)

Aventure AB; 🇸🇪 Lund, Sweden