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

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose Response
• Intervention / Treatment: Other: Reference Product; Other: Wholegrain product Dose A; Other: Wholegrain product Dose B; Other: Wholegrain product Dose A, cut kernels

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Aventure AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Reference	Other: Reference Product; This intervention is based on white rice.
Active Comparator: Whole cereal kernels Dose A	Other: Wholegrain product Dose A; This wholegrain intervention contains whole cereal kernels.
Active Comparator: Whole cereal kernels Dose B	Other: Wholegrain product Dose B; This wholegrain intervention contains whole cereal kernels.
Active Comparator: Cut cereal kernels Dose A	Other: Wholegrain product Dose A, cut kernels; This wholegrain intervention contains cut cereal kernels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Aventure AB

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TSP2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No