Healthy
Conditions
Brief summary
The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.
Detailed description
Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.
Interventions
OTHERProduct 1: Milk
Developed reference product based on milk
OTHERProduct 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
OTHERProduct 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
OTHERBread reference
Commercially available white wheat bread
OTHERProduct 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Sponsors
Aventure AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 20 to 40 years of age 2. BMI 20-27 (±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 (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5) 2. Elevated fasting insulin (above 25 mIE/L) 3. Women who are pregnant or breast feeding 4. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI 5. 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 SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician. 6. Known Type I or Type II diabetes, including women who previously have had gestational diabetes. 7. Use of antibiotics within 2 weeks of enrollment 8. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.) 9. Allergy to ingredients included in investigational product, placebo or standardized meal 10. Participants restricted to a vegetarian or vegan diet 11. Intolerance to lactose or gluten 12. Individuals who are averse to venous catheterization or capillary blood sampling 13. Currently active smokers (or using other tobacco products, and e-cigarettes) 14. Unstable medical conditions as determined by SI 15. Participation in other clinical research trials 16. Individuals who are cognitively impaired and/or who are unable to give informed consent 17. Acute infection 18. Any other condition which in the SI'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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycaemia capillary | 0-120 min after consumption | Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Cmax capillary glucose | 0-180 min | The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference. |
| Postprandial Cmax venous glucose | 0-180 min | The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference. |
| Postprandial glycaemia capillary | 0-180 min | The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference. |
| Postprandial glycaemia venous | 0-180 min | The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference. |
| Postprandial glycaemia Tmax capillary | 0-180 min | The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference. |
| Postprandial glycaemia Tmax venous | 0-180 min | The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference. |
| Postprandial glycaemia intravenous | 0-120 min | The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference. |
| Postprandial insulinaemia Cmax | 0-180 min | The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference. |
| Postprandial insulinaemia Tmax | 0-180 min | The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference. |
| Postprandial GLP-1 bread reference | 0-60 min | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference. |
| Postprandial GLP-1, yoghurt control | 0-60 min | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1. |
| Postprandial GLP-1 Cmax bread reference | 0-60 min | The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference. |
| Postprandial GLP-1 Cmax yoghurt control | 0-60 min | The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1. |
| Postprandial insulinaemia | 0-180 min | The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference. |
Countries
Sweden
Outcome results
None listed