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

NCT ID: NCT05291806

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-06-13

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.

Conditions

Blood Glucose Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Reference

Group Type: PLACEBO_COMPARATOR

Reference Product

Intervention Type: OTHER

This intervention is based on white rice.

Whole cereal kernels Dose A

Group Type: ACTIVE_COMPARATOR

Wholegrain product Dose A

Intervention Type: OTHER

This wholegrain intervention contains whole cereal kernels.

Whole cereal kernels Dose B

Group Type: ACTIVE_COMPARATOR

Wholegrain product Dose B

Intervention Type: OTHER

This wholegrain intervention contains whole cereal kernels.

Cut cereal kernels Dose A

Group Type: ACTIVE_COMPARATOR

Wholegrain product Dose A, cut kernels

Intervention Type: OTHER

This wholegrain intervention contains cut cereal kernels.

Interventions

Reference Product

This intervention is based on white rice.

Intervention Type: OTHER

Wholegrain product Dose A

This wholegrain intervention contains whole cereal kernels.

Intervention Type: OTHER

Wholegrain product Dose B

This wholegrain intervention contains whole cereal kernels.

Intervention Type: OTHER

Wholegrain product Dose A, cut kernels

This wholegrain intervention contains cut cereal kernels.

Intervention Type: OTHER

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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• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aventure AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aventure AB

Lund, , Sweden

Countries

Sweden

Other Identifiers

TSP2201

Identifier Type: -

Identifier Source: org_study_id