Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals

Aventure

Status: Completed

Conditions: Blood Glucose

Treatments: Other: Breakfast product: Reference; Other: Breakfast product: Whole grain

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04888559

TSP2101

Details and patient eligibility

About

In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population.

Enrollment: 10 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 22-29 (±0.5) 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 or 2)
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, placebo, or standardized meal
9. Participants restricted to a vegetarian or vegan diet
10. Intolerance to gluten
11. Individuals who are averse to 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: Single Blind

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10 participants in 2 patient groups, including a placebo group

Whole grain breakfast product

Active Comparator group

Treatment:

Other: Breakfast product: Whole grain

Reference

Placebo Comparator group

Treatment:

Other: Breakfast product: Reference