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

Blood Glucose Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291806
• Other study ID #: TSP2201
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: June 13, 2022

Study information

• Verified date: March 2022
• Source: Aventure AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Blood Glucose Response

Intervention

Other:
• Reference Product
This intervention is based on white rice.
• Wholegrain product Dose A
This wholegrain intervention contains whole cereal kernels.
• Wholegrain product Dose B
This wholegrain intervention contains whole cereal kernels.
• Wholegrain product Dose A, cut kernels
This wholegrain intervention contains cut cereal kernels.

Locations

Country	Name	City	State
Sweden	Aventure AB	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Aventure AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting GLP-1	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.
Other	GLP-1 iAUC(0-120 min)	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.
Other	GLP-1 iAUC(0-60 min)	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.
Other	GLP-1 Cmax	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.
Other	GLP-1 Tmax	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.
Other	Fasting PYY	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.
Other	PYY 2-hour mean concentration	The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.	Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Other	PYY 1-hour mean concentration	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.
Primary	Postprandial capillary blood glucose iAUC (0-120 min)	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.
Secondary	Postprandial capillary blood glucose Cmax	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.
Secondary	Postprandial capillary blood glucose Tmax	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.
Secondary	Fasting capillary blood glucose	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.
Secondary	Postprandial capillary blood glucose iAUC (0-60 min)	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.
Secondary	Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)	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.
Secondary	Postprandial Insulin iAUC(0-120 min)	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.
Secondary	Postprandial Insulin Cmax	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.
Secondary	Postprandial Insulin Tmax	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.
Secondary	Fasting Insulin	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.
Secondary	Postprandial insulin iAUC (0-60 min)	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.
Secondary	Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)	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.