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

Aventure

Status: Completed

Conditions: Blood Glucose Response

Treatments: Other: Wholegrain product Dose A, cut kernels; Other: Wholegrain product Dose B; Other: Reference Product; Other: Wholegrain product Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05291806

TSP2201

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 4 patient groups, including a placebo group

Reference

Placebo Comparator group

Treatment:

Other: Reference Product

Whole cereal kernels Dose A

Active Comparator group

Treatment:

Other: Wholegrain product Dose A

Whole cereal kernels Dose B

Active Comparator group

Treatment:

Other: Wholegrain product Dose B

Cut cereal kernels Dose A

Active Comparator group

Treatment:

Other: Wholegrain product Dose A, cut kernels